Delivery Method:VIA ELECTRONIC MAIL READ/DELIVERY RECEIPT REQUESTEDProduct:DrugsRecipient:Lean Rx, Inc. dba SkinnyRx2108 N St Ste NSacramento,CA95816United Statessupport@skinnyrx.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERFebruary 20, 2026SkinnyRx:This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website content at the internet address https://skinnyrx.com, in December 2025, and has observed that your website offers compounded drug products, including semaglutide and tirzepatide drug products.1As described below, your website’s false or misleading claims concerning compounded semaglutide and tirzepatide products under sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act (FDCA) [21 U.S.C. §§ 352(a) and 352(bb)], result in products being introduced or delivered for introduction into interstate commerce in violation of section 301(a) of the FDCA [21 U.S.C. § 331(a)].Under section 502(a) of the FDCA [21 U.S.C. § 352(a)] a drug is misbranded if its labeling is false or misleading in any particular. Furthermore, under section 502(bb) of the FDCA [21 U.S.C. § 352(bb)], a compounded drug is misbranded if its advertising or promotion is false or misleading in any particular.The compounded semaglutide and tirzepatide products displayed on your website identify “SkinnyRx” on the pictured label, suggesting SkinnyRx is the compounder of those drugs when in fact it is not.2Accordingly, the representations on your website that SkinnyRx is the compounder of these drug products are false or misleading, and the products are therefore misbranded under sections 502(a) and 502(bb) of the FDCA [21 U.S.C. §§ 352(a) and (bb)].Additionally, the following claims concerning compounded semaglutide and tirzepatide products appear on your website:“from the same family as GLP-1 treatments like Mounjaro® and Zepbound®”“Get access to the same active ingredient as name-brand GLP-1 medications”“It contains the same active ingredient as FDA-approved medications”Compounded drug products are not FDA-approved. Your claims imply that your products have been FDA-approved or otherwise evaluated for safety and effectiveness when they have not. As a result, these claims are false or misleading and your products are therefore misbranded under sections 502(a) and 502(bb) of the FDCA [21 U.S.C. §§ 352(a) and (bb)].The introduction or delivery for introduction into interstate commerce of these misbranded products is a prohibited act under section 301(a) of the FDCA [21 U.S.C. § 331(a)]. The representations and claims identified in this letter put you on notice of our concerns but do not represent an exhaustive list of violations.For the reasons discussed above, your compounded semaglutide and tirzepatide products are misbranded drugs under sections 502(a) and 502(bb) of the FDCA [21 U.S.C. §§ 352(a) and 352(bb)], introduced or delivered for introduction into interstate commerce in violation of section 301(a) of the FDCA [21 U.S.C. § 331(a)]. Please be advised, the receipt in interstate commerce of misbranded drugs, and the delivery or proffered delivery thereof, is also a violation of section 301(c) of the FDCA [21 U.S.C. § 331(c)].As previously stated, the violations cited in this letter are not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your operations comply with all requirements of federal law, including FDA regulations. For example, compounded drug products must meet the conditions in sections 503A or 503B of the FD&C Act [21 U.S.C. §§ 353a or 353b] in order to be exempt from certain requirements under the Act, including the new drug approval requirements.You should take immediate action to address any violations. Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.Within fifteen (15) working days of receipt of this letter, please provide a written response to the Office of Compounding Quality and Compliance (OCQC) within the Center for Drug Evaluation and Research (CDER)’s Office of Compliance describing the specific steps you have taken to address any violations. Please include an explanation of each step being taken to prevent the recurrence of any violations, as well as copies of related documentation. Such steps may include:1) Identifying the entities that produce the compounded products offered on your website;2) Providing a representative sample of labeling for such products; and3) Addressing the basis for other website claims that could be construed as false or misleading or demonstrating that such claims have been modified or removed in light of FDCA §§ 502(a) and 502(bb)) [21 U.S.C. §§ 352(a) and (bb)].This letter notifies you of our concerns and provides you an opportunity to address them. In your written response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices. If you cannot completely address this matter within fifteen (15) working days, state the reason for the delay and the time within which you will do so.If you are not located in the U.S., please note that products that appear to be misbranded may be detained or refused admission. We may advise the appropriate regulatory officials in the country from which you operate that your products referenced above appear to be misbranded products that cannot be legally sold to consumers in the U.S.All correspondence should include a subject line that clearly identifies the submission as a Response to Warning Letter. If you have questions regarding the contents of this letter, please contact compoundinginspections@fda.hhs.gov.Sincerely,/S/Matthew J. LashActing DirectorOffice of Compounding Quality and ComplianceOffice of ComplianceCenter for Drug Evaluation and Research______________________1The semaglutide and tirzepatide products offered on your website are drugs within the meaning of section 201(g) of the FDCA [21 U.S.C. § 321(g)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases and/or because they are intended to affect the structure or any function of the body. Further, they are “new drugs” within the meaning of section 201(p) of the FDCA [21 U.S.C. § 321(p)] because they are not generally recognized as safe and effective for their labeled uses.2See also 21 CFR § 201.1(h)(2) (“The appearance on a drug product label of a person’s name without qualification is a representation that the named person is the sole manufacturer of the product. That representation is false and misleading, and the drug product is misbranded under section 502(a) of the act, if the person is not the manufacturer of the product in accordance with this section.”); FDCA §503(b) [21 § U.S.C. 353(b)], FDCA §503B(a)(10)(A)(ii) [21 U.S.C. § 353b(a)(10)(A)(ii)]. We note that 21 CFR § 201.1(a) does not apply to drug products dispensed in accordance with section 503(b)(1) of the FDCA [21 USC § 353(b)(1)]. However, see 45 Fed. Reg. 25760, 25765 (Apr. 15, 1980) (“…if the label of a prescription drug product dispensed by a pharmacist does contain a representation as to the manufacturer, packer, or distributor, it must comply with all the provisions of § 201.1…”). In addition, the labels of your drug products as depicted on the website do not indicate that they are dispensed under section 503(b)(1) of the FDCA [21 USC § 353(b)(1)], nor do they appear to comply with the requirements of section 503(b)(2) [21 USC § 353(b)(2)].

Delivery Method:VIA ELECTRONIC MAIL READ/DELIVERY RECEIPT REQUESTEDProduct:DrugsRecipient:Peaks Curative, LLC dba PeaksUnited Statescontact@peakscurative.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERFebruary 20, 2026Peaks:This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website content at the internet address https://peakscurative.com, in December 2025, and has observed that your website offers compounded drug products, including semaglutide drug products.1As described below, your website’s false or misleading claims concerning compounded semaglutide products under sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act (FDCA) [21 U.S.C. §§ 352(a) and 352(bb)], result in products being introduced or delivered for introduction into interstate commerce in violation of section 301(a) of the FDCA [21 U.S.C. § 331(a)].Under section 502(a) of the FDCA [21 U.S.C. § 352(a)] a drug is misbranded if its labeling is false or misleading in any particular. Furthermore, under section 502(bb) of the FDCA [21 U.S.C. § 352(bb)], a compounded drug is misbranded if its advertising or promotion is false or misleading in any particular.The compounded semaglutide products displayed on your website identify “Peak Now” on the pictured label, suggesting Peak Now is the compounder of those drugs when in fact it is not.2Accordingly, the representations on your website that Peak Now is the compounder of these drug products are false or misleading, and the products are therefore misbranded under sections 502(a) and 502(bb) of the FDCA [21 U.S.C. §§ 352(a) and (bb)].Additionally, the following claims concerning compounded semaglutide products appear on your website:“This FDA-approved treatment promotes safe, effective weight loss, helping you reduce up to 20% of your body weight and maintain long-term results.”“Clinically proven to aid in significant weight loss in overweight adults.”“Safe, affordable, and effective.”“The compounded products offered on PeaksCurative.com use FDA approved active pharmaceutical ingredients (API).”Compounded drug products are not FDA-approved. Your claims imply that your products have been FDA-approved or otherwise evaluated for safety and effectiveness when they have not. As a result, these claims are false or misleading and your products are therefore misbranded under sections 502(a) and 502(bb) of the FDCA [21 U.S.C. §§ 352(a) and (bb)].The introduction or delivery for introduction into interstate commerce of these misbranded products is a prohibited act under section 301(a) of the FDCA [21 U.S.C. § 331(a)]. The representations and claims identified in this letter put you on notice of our concerns but do not represent an exhaustive list of violations.For the reasons discussed above, your compounded semaglutide products are misbranded drugs under sections 502(a) and 502(bb) of the FDCA [21 U.S.C. §§ 352(a) and 352(bb)], introduced or delivered for introduction into interstate commerce in violation of section 301(a) of the FDCA [21 U.S.C. § 331(a)]. Please be advised, the receipt in interstate commerce of misbranded drugs, and the delivery or proffered delivery thereof, is also a violation of section 301(c) of the FDCA [21 U.S.C. § 331(c)].As previously stated, the violations cited in this letter are not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your operations comply with all requirements of federal law, including FDA regulations. For example, compounded drug products must meet the conditions in sections 503A or 503B of the FD&C Act [21 U.S.C. §§ 353a or 353b] in order to be exempt from certain requirements under the Act, including the new drug approval requirements.You should take immediate action to address any violations. Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.Within fifteen (15) working days of receipt of this letter, please provide a written response to the Office of Compounding Quality and Compliance (OCQC) within the Center for Drug Evaluation and Research (CDER)’s Office of Compliance describing the specific steps you have taken to address any violations. Please include an explanation of each step being taken to prevent the recurrence of any violations, as well as copies of related documentation. Such steps may include:1) Identifying the entities that produce the compounded products offered on your website;2) Providing a representative sample of labeling for such products; and3) Addressing the basis for other website claims that could be construed as false or misleading or demonstrating that such claims have been modified or removed in light of FDCA §§ 502(a) and 502(bb)) [21 U.S.C. §§ 352(a) and (bb)].This letter notifies you of our concerns and provides you an opportunity to address them. In your written response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices. If you cannot completely address this matter within fifteen (15) working days, state the reason for the delay and the time within which you will do so.If you are not located in the U.S., please note that products that appear to be misbranded may be detained or refused admission. We may advise the appropriate regulatory officials in the country from which you operate that your products referenced above appear to be misbranded products that cannot be legally sold to consumers in the U.S.All correspondence should include a subject line that clearly identifies the submission as a Response to Warning Letter. If you have questions regarding the contents of this letter, please contact compoundinginspections@fda.hhs.gov.Sincerely,/S/Matthew J. LashActing DirectorOffice of Compounding Quality and ComplianceOffice of ComplianceCenter for Drug Evaluation and Research___________________1The semaglutide products offered on your website are drugs within the meaning of section 201(g) of the FDCA [21 U.S.C. § 321(g)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases and/or because they are intended to affect the structure or any function of the body. Further, they are “new drugs” within the meaning of section 201(p) of the FDCA [21 U.S.C. § 321(p)] because they are not generally recognized as safe and effective for their labeled uses.2See also 21 CFR § 201.1(h)(2) (“The appearance on a drug product label of a person’s name without qualification is a representation that the named person is the sole manufacturer of the product. That representation is false and misleading, and the drug product is misbranded under section 502(a) of the act, if the person is not the manufacturer of the product in accordance with this section.”); FDCA §503(b) [21 § U.S.C. 353(b)], FDCA §503B(a)(10)(A)(ii) [21 U.S.C. § 353b(a)(10)(A)(ii)]. We note that 21 CFR § 201.1(a) does not apply to drug products dispensed in accordance with section 503(b)(1) of the FDCA [21 USC § 353(b)(1)]. However, see 45 Fed. Reg. 25760, 25765 (Apr. 15, 1980) (“…if the label of a prescription drug product dispensed by a pharmacist does contain a representation as to the manufacturer, packer, or distributor, it must comply with all the provisions of § 201.1…”). In addition, the labels of your drug products as depicted on the website do not indicate that they are dispensed under section 503(b)(1) of the FDCA [21 USC § 353(b)(1)], nor do they appear to comply with the requirements of section 503(b)(2) [21 USC § 353(b)(2)].

Delivery Method:VIA ELECTRONIC MAIL READ/DELIVERY RECEIPT REQUESTEDProduct:DrugsRecipient:Simal Patel, MDChief Executive OfficerStrut Health, LLC dba Strut701 Commerce StDallas,TX75202United Statescare@struthealth.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERFebruary 20, 2026Dr. Patel:This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website content at the internet address https://www.struthealth.com, in December 2025, and has observed that your website offers compounded drug products, including semaglutide and tirzepatide drug products.1As described below, your website’s false or misleading claims concerning compounded semaglutide and tirzepatide products under sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act (FDCA) [21 U.S.C. §§ 352(a) and 352(bb)], result in products being introduced or delivered for introduction into interstate commerce in violation of section 301(a) of the FDCA [21 U.S.C. § 331(a)].Under section 502(a) of the FDCA [21 U.S.C. § 352(a)] a drug is misbranded if its labeling is false or misleading in any particular. Furthermore, under section 502(bb) of the FDCA [21 U.S.C. § 352(bb)], a compounded drug is misbranded if its advertising or promotion is false or misleading in any particular.The compounded semaglutide and tirzepatide products displayed on your website identify “Strut” on the pictured label, suggesting Strut is the compounder of those drugs when in fact it is not.2Accordingly, the representations on your website that Strut is the compounder of these drug products are false or misleading, and the products are therefore misbranded under sections 502(a) and 502(bb) of the FDCA [21 U.S.C. §§ 352(a) and (bb)].Additionally, the following claims concerning compounded semaglutide and tirzepatide products appear on your website:“Generic Zepbound, Mounjaro”“Semaglutide is the active ingredient in the brand medications.”“Tirzepatide is the active ingredient in the brand medications Zepbound® and Mounjaro®.”Compounded drug products are not FDA-approved. Your claims imply that your products have been FDA-approved or otherwise evaluated for safety and effectiveness when they have not. As a result, these claims are false or misleading and your products are therefore misbranded under sections 502(a) and 502(bb) of the FDCA [21 U.S.C. §§ 352(a) and (bb)].The introduction or delivery for introduction into interstate commerce of these misbranded products is a prohibited act under section 301(a) of the FDCA [21 U.S.C. § 331(a)]. The representations and claims identified in this letter put you on notice of our concerns but do not represent an exhaustive list of violations.For the reasons discussed above, your compounded semaglutide and tirzepatide products are misbranded drugs under sections 502(a) and 502(bb) of the FDCA [21 U.S.C. §§ 352(a) and 352(bb)], introduced or delivered for introduction into interstate commerce in violation of section 301(a) of the FDCA [21 U.S.C. § 331(a)]. Please be advised, the receipt in interstate commerce of misbranded drugs, and the delivery or proffered delivery thereof, is also a violation of section 301(c) of the FDCA [21 U.S.C. § 331(c)].As previously stated, the violations cited in this letter are not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your operations comply with all requirements of federal law, including FDA regulations. For example, compounded drug products must meet the conditions in sections 503A or 503B of the FD&C Act [21 U.S.C. §§ 353a or 353b] in order to be exempt from certain requirements under the Act, including the new drug approval requirements.You should take immediate action to address any violations. Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.Within fifteen (15) working days of receipt of this letter, please provide a written response to the Office of Compounding Quality and Compliance (OCQC) within the Center for Drug Evaluation and Research (CDER)’s Office of Compliance describing the specific steps you have taken to address any violations. Please include an explanation of each step being taken to prevent the recurrence of any violations, as well as copies of related documentation. Such steps may include:1) Identifying the entities that produce the compounded products offered on your website;2) Providing a representative sample of labeling for such products; and3) Addressing the basis for other website claims that could be construed as false or misleading or demonstrating that such claims have been modified or removed in light of FDCA §§ 502(a) and 502(bb)) [21 U.S.C. §§ 352(a) and (bb)].This letter notifies you of our concerns and provides you an opportunity to address them. In your written response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices. If you cannot completely address this matter within fifteen (15) working days, state the reason for the delay and the time within which you will do so.If you are not located in the U.S., please note that products that appear to be misbranded may be detained or refused admission. We may advise the appropriate regulatory officials in the country from which you operate that your products referenced above appear to be misbranded products that cannot be legally sold to consumers in the U.S.All correspondence should include a subject line that clearly identifies the submission as a Response to Warning Letter. If you have questions regarding the contents of this letter, please contact compoundinginspections@fda.hhs.gov.Sincerely,/S/Matthew J. LashActing DirectorOffice of Compounding Quality and ComplianceOffice of ComplianceCenter for Drug Evaluation and Research__________________1The semaglutide and tirzepatide products offered on your website are drugs within the meaning of section 201(g) of the FDCA [21 U.S.C. § 321(g)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases and/or because they are intended to affect the structure or any function of the body. Further, they are “new drugs” within the meaning of section 201(p) of the FDCA [21 U.S.C. § 321(p)] because they are not generally recognized as safe and effective for their labeled uses.2See also 21 CFR § 201.1(h)(2) (“The appearance on a drug product label of a person’s name without qualification is a representation that the named person is the sole manufacturer of the product. That representation is false and misleading, and the drug product is misbranded under section 502(a) of the act, if the person is not the manufacturer of the product in accordance with this section.”); FDCA §503(b) [21 § U.S.C. 353(b)], FDCA §503B(a)(10)(A)(ii) [21 U.S.C. § 353b(a)(10)(A)(ii)]. We note that 21 CFR § 201.1(a) does not apply to drug products dispensed in accordance with section 503(b)(1) of the FDCA [21 USC § 353(b)(1)]. However, see 45 Fed. Reg. 25760, 25765 (Apr. 15, 1980) (“…if the label of a prescription drug product dispensed by a pharmacist does contain a representation as to the manufacturer, packer, or distributor, it must comply with all the provisions of § 201.1…”). In addition, the labels of your drug products as depicted on the website do not indicate that they are dispensed under section 503(b)(1) of the FDCA [21 USC § 353(b)(1)], nor do they appear to comply with the requirements of section 503(b)(2) [21 USC § 353(b)(2)].

Delivery Method:VIA ELECTRONIC MAIL READ/DELIVERY RECEIPT REQUESTEDProduct:DrugsRecipient:Kare Solutions, LLC dba Zappy7660H Fay Ave, Suite 504La Jolla,CA92037United Statescustomer@zappyhealth.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERFebruary 20, 2026Zappy:This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website content at the internet address https://zappyhealth.com, in December 2025, and has observed that your website offers compounded drug products, including semaglutide, tirzepatide, and liraglutide drug products.1As described below, your website’s false or misleading claims concerning compounded semaglutide, tirzepatide, and liraglutide products under sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act (FDCA) [21 U.S.C. §§ 352(a) and 352(bb)], result in products being introduced or delivered for introduction into interstate commerce in violation of section 301(a) of the FDCA [21 U.S.C. § 331(a)].Under section 502(a) of the FDCA [21 U.S.C. § 352(a)] a drug is misbranded if its labeling is false or misleading in any particular. Furthermore, under section 502(bb) of the FDCA [21 U.S.C. § 352(bb)], a compounded drug is misbranded if its advertising or promotion is false or misleading in any particular.The compounded semaglutide, tirzepatide, and liraglutide products displayed on your website identify “Zappy” on the pictured label, suggesting Zappy is the compounder of those drugs when in fact it is not.2Accordingly, the representations on your website that Zappy is the compounder of these drug products are false or misleading, and the products are therefore misbranded under sections 502(a) and 502(bb) of the FDCA [21 U.S.C. §§ 352(a) and (bb)].Additionally, the following claims concerning compounded semaglutide, tirzepatide, and liraglutide products appear on your website:“Semaglutide (Active Pharmaceutical Ingredient in Wegovy®)See Wegovy FDA Information” [sic]“Liraglutide (Active Pharmaceutical Ingredient in Saxenda®)See Saxenda FDA Information” [sic]“Tirzepatide (Active Pharmaceutical Ingredient in Zepbound®)See Zepbound FDA Information” [sic]“a proven medication”“Clinically studied and shown to deliver powerful results when combined with healthy habits.”Compounded drug products are not FDA-approved. Your claims imply that your products have been FDA-approved or otherwise evaluated for safety and effectiveness when they have not. As a result, these claims are false or misleading and your products are therefore misbranded under sections 502(a) and 502(bb) of the FDCA [21 U.S.C. §§ 352(a) and (bb)].The introduction or delivery for introduction into interstate commerce of these misbranded products is a prohibited act under section 301(a) of the FDCA [21 U.S.C. § 331(a)]. The representations and claims identified in this letter put you on notice of our concerns but do not represent an exhaustive list of violations.For the reasons discussed above, your compounded semaglutide, tirzepatide, and liraglutide products are misbranded drugs under sections 502(a) and 502(bb) of the FDCA [21 U.S.C. §§ 352(a) and 352(bb)], introduced or delivered for introduction into interstate commerce in violation of section 301(a) of the FDCA [21 U.S.C. § 331(a)]. Please be advised, the receipt in interstate commerce of misbranded drugs, and the delivery or proffered delivery thereof, is also a violation of section 301(c) of the FDCA [21 U.S.C. § 331(c)].As previously stated, the violations cited in this letter are not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your operations comply with all requirements of federal law, including FDA regulations. For example, compounded drug products must meet the conditions in sections 503A or 503B of the FD&C Act [21 U.S.C. §§ 353a or 353b] in order to be exempt from certain requirements under the Act, including the new drug approval requirements.You should take immediate action to address any violations. Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.Within fifteen (15) working days of receipt of this letter, please provide a written response to the Office of Compounding Quality and Compliance (OCQC) within the Center for Drug Evaluation and Research (CDER)’s Office of Compliance describing the specific steps you have taken to address any violations. Please include an explanation of each step being taken to prevent the recurrence of any violations, as well as copies of related documentation. Such steps may include:1) Identifying the entities that produce the compounded products offered on your website;2) Providing a representative sample of labeling for such products; and3) Addressing the basis for other website claims that could be construed as false or misleading or demonstrating that such claims have been modified or removed in light of FDCA §§ 502(a) and 502(bb)) [21 U.S.C. §§ 352(a) and (bb)].This letter notifies you of our concerns and provides you an opportunity to address them. In your written response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices. If you cannot completely address this matter within fifteen (15) working days, state the reason for the delay and the time within which you will do so.If you are not located in the U.S., please note that products that appear to be misbranded may be detained or refused admission. We may advise the appropriate regulatory officials in the country from which you operate that your products referenced above appear to be misbranded products that cannot be legally sold to consumers in the U.S.All correspondence should include a subject line that clearly identifies the submission as a Response to Warning Letter. If you have questions regarding the contents of this letter, please contact compoundinginspections@fda.hhs.gov.Sincerely,/S/Matthew J. LashActing DirectorOffice of Compounding Quality and ComplianceOffice of ComplianceCenter for Drug Evaluation and Research______________________1The semaglutide, tirzepatide, and liraglutide products offered on your website are drugs within the meaning of section 201(g) of the FDCA [21 U.S.C. § 321(g)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases and/or because they are intended to affect the structure or any function of the body. Further, they are “new drugs” within the meaning of section 201(p) of the FDCA [21 U.S.C. § 321(p)] because they are not generally recognized as safe and effective for their labeled uses.2See also 21 CFR § 201.1(h)(2) (“The appearance on a drug product label of a person’s name without qualification is a representation that the named person is the sole manufacturer of the product. That representation is false and misleading, and the drug product is misbranded under section 502(a) of the act, if the person is not the manufacturer of the product in accordance with this section.”); FDCA §503(b) [21 § U.S.C. 353(b)], FDCA §503B(a)(10)(A)(ii) [21 U.S.C. § 353b(a)(10)(A)(ii)]. We note that 21 CFR § 201.1(a) does not apply to drug products dispensed in accordance with section 503(b)(1) of the FDCA [21 USC § 353(b)(1)]. However, see 45 Fed. Reg. 25760, 25765 (Apr. 15, 1980) (“…if the label of a prescription drug product dispensed by a pharmacist does contain a representation as to the manufacturer, packer, or distributor, it must comply with all the provisions of § 201.1…”). In addition, the labels of your drug products as depicted on the website do not indicate that they are dispensed under section 503(b)(1) of the FDCA [21 USC § 353(b)(1)], nor do they appear to comply with the requirements of section 503(b)(2) [21 USC § 353(b)(2)].

Delivery Method:VIA Electronic MailProduct:DrugsRecipient:Samuel MironChief Executive OfficerGenoGenix LLC2840 NW 2nd Ave, Suites 204 & 205Boca Raton,FL33431-6692United StatesIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERWL # 718739January 20, 2026Dear Mr. Miron:You registered your facility with the U.S. Food and Drug Administration (FDA) as an outsourcing facility under section 503B of the Federal Food, Drug, and Cosmetic Act (FDCA) [21 U.S.C. § 353b]1on February 4, 2025. From July 14, 2025, to July 18, 2025, FDA investigators inspected your facility, GenoGenix LLC, located at 2840 NW 2nd Ave, Suites 204 & 205, Boca Raton, FL 33431. During the inspection, the investigators noted that drug products you produced failed to meet the conditions of section 503B of the FDCA necessary for drugs produced by an outsourcing facility to qualify for exemptions from certain provisions of the FDCA. In addition, the investigators noted serious deficiencies in your practices for producing drug products, which put patients at risk.FDA issued a Form FDA 483 to your facility on July 18, 2025, and issued an amended Form FDA 483 on July 31, 2025. We reviewed your August 29, 2025, September 30, 2025, October 31, 2025, and November 30, 2025, responses to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence. FDA acknowledges that your firm has ceased drug production and distribution. FDA also acknowledges that on July 30, 2025, your firm initiated a voluntary recall of drug products intended or expected to be sterile, within expiry, due to lack of sterility assurance or microbial contamination. Based on this inspection, it appears you produced drugs that violate the FDCA.A. Compounded Drug Products under the FDCAUnder section 503B(b) of the FDCA, a compounder can register as an outsourcing facility with FDA. Drug products compounded by or under the direct supervision of a licensed pharmacist in an outsourcing facility qualify for exemptions from the drug approval requirements in section 505 of the FDCA [21 U.S.C. § 355(a)], the requirement in section 502(f)(1) of the FDCA [21 U.S.C. § 352(f)(1)] that labeling bear adequate directions for use and the Drug Supply Chain Security Act requirements in section 582 of the FDCA [21 U.S.C. § 360eee-1] if the conditions in section 503B of the FDCA are met.2An outsourcing facility, which is defined in section 503B(d)(4) of the FDCA [21 U.S.C. § 353b(d)(4)], is a facility at one geographic location or address that — (i) is engaged in the compounding of sterile drugs; (ii) has elected to register as an outsourcing facility; and (iii) complies with all of the requirements of this section. Outsourcing facilities must comply with other applicable provisions of the FDCA, including section 501(a)(2)(B) [21 U.S.C. § 351(a)(2)(B)], regarding current good manufacturing practice (CGMP), and section 501(a)(2)(A) [21 U.S.C. § 351(a)(2)(A)], regarding insanitary conditions. Generally, CGMP requirements for the preparation of drug products are established in Title 21 of the Code of Federal Regulations (CFR) parts 210 and 211.In addition, for a drug product compounded using bulk drug substances to qualify for exemptions under section 503B, the bulk drug substances that are used must appear on a list established by the Secretary identifying bulk drug substances for which there is a clinical need (“503B bulks list”), or the compounded drug must appear on the drug shortage list in effect under section 506E of the FDCA at the time of compounding, distribution, and dispensing (section 503B(a)(2)(A)(i) of the FDCA [21 U.S.C. § 353b(a)(2)(A)]).Furthermore, for a compounded drug product to qualify for the exemptions under section 503B, the labeling of the drug must include certain information (section 503B(a)(10) of the FDCA [21 U.S.C. §353b(a)(10)]).]Moreover, for a compounded drug product to qualify for the exemptions under section 503B, it must be compounded in an outsourcing facility that is in compliance with the registration and reporting requirements in section 503B(b), including the requirement to submit a report to FDA upon initially registering as an outsourcing facility, once in June of each year, and once in December of each year identifying the drug products compounded during the previous 6-month period (section 503B(b)(2) of the FDCA [21 U.S.C. §353b(b)(2)]), and the requirement to submit adverse event reports to FDA “in accordance with the content and format requirements established through guidance or regulation under section 310.305 of title 21, Code of Federal Regulations (or any successor regulations)” (section 503B(a)(1), (b)(5) of the FDCA [21 U.S.C. § 353b(a)(1), (b)(5)]).B. Failure to Meet the Conditions of Section 503BDuring the inspection, the FDA investigators noted that drug products produced by your facility failed to meet the conditions of section 503B. For example, the investigators noted:1. Your facility compounded drug products using bulk drug substances that are not eligible for the use in compounding under section 503B, including 5-amino-1-methylquinolinium iodide (5-Amino-1MQ) and nicotinamide adenine dinucleotide (NAD+). Drug products compounded using 5-Amino-1MQ and NAD+ are not eligible for the exemptions provided by section 503B, because 5-Amino-1MQ and NAD+ do not appear on the 503B bulks list and are not used to compound a drug that appears on the drug shortage list.32. Some of your facility’s drug products did not include the following required information on the label:a. The statement “this is a compounded drug.” Examples include Glutathione Magnesium, Reconstitution Solution, and Epithalon.b. The name, address, and phone number of the outsourcing facility. Examples include Glutathione Magnesium, Reconstitution Solution, and Epithalon.c. The established name of the drug. Examples include Rapamycin, Clear Mind 150, and LIPO (MIC) + B.d. The dosage form of the drug. Examples include LIPO (MIC) + B, Ascorbic Acid Vitamin C, Alpha Lipoic Acid, and Epithalon.e. Storage and handling instructions. Examples include Epithalon.f. The statement “Not for resale,” and, if the drug is dispensed or distributed other than pursuant to a prescription for an individual identified patient, the statement “Office Use Only.” Examples include Glutathione Magnesium, Reconstitution Solution, and Epithalon.3. Some of your facility’s drug products did not include a list of active and inactive ingredients, identified by established name and the quantity or proportion of each ingredient on the label or container. Examples include Rapamycin, Clear Mind 150, Alpha Lipoic Acid, and Epithalon.4. Some of your facility’s drug products did not include the following information on the container:a. Information to facilitate adverse event reporting: www.fda.gov/medwatch and 1-800-FDA-1088.b. Directions for use, including, as appropriate, dosage and administration.Examples include Immune Defense Nasal Spray.5. Your facility failed to submit a report to FDA upon initially registering as an outsourcing facility in February 2025 and in June 2025 identifying the drug products that you compounded during the previous 6-month period.6. Your facility did not submit adverse event reports to FDA in accordance with the content and format requirements established through guidance or regulation under section 310.305 of title 21, Code of Federal Regulations (or any successor regulations).4Specifically, you do not have any documented procedures for reporting adverse events.Because your compounded drug products have not met all of the conditions of section 503B, they are not eligible for the exemptions in that section from the FDA approval requirements of section 505, the requirement under section 502(f)(1) that labeling bear adequate directions for use, and the Drug Supply Chain Security Act requirements described in section 582 of the FDCA.Specific violations are described below.C. Violations of the FDCAAdulterated Drug ProductsFDA investigators noted that drug products intended or expected to be sterile were prepared, packed, or held under insanitary conditions, whereby they may have become contaminated with filth or rendered injurious to health, causing your drug products to be adulterated under section 501(a)(2)(A) of the FDCA. For example, the investigators observed that:1. An operator blocked first air by placing gloved hands directly over open sterile containers.2. An operator manually touched a product contact surface by reaching into a bag of stoppers with gloved hands, then hand stoppered vials of drug product.3. Operators did not disinfect materials at each transition from areas of lower quality air to areas of higher quality air.4. An operator placed components within the ISO(b)(4)hood that had the potential to block the movement of first air to critical in-process operations.5. Personnel engaged in aseptic processing while exposing skin within the ISO(b)(4)aseptic processing area.6. Personnel performing sterile operations never conducted media fills. Therefore, there is a lack of assurance that your firm can aseptically produce drug products within your facility.7. Your firm lacks adequate routine environmental monitoring. Specifically, your firm has never performed personnel or environmental monitoring during the production of drug products.8. Your firm failed to conduct(b)(4)testing on(b)(4)used to sterilize drug products. Therefore, you do not have assurance that the(b)(4)throughout use.9. Your firm failed to perform adequate smoke studies under dynamic conditions to demonstrate unidirectional airflow within the ISO(b)(4)area. Therefore, your products intended to be sterile are produced in an environment that may not provide adequate protection against the risk of contamination.10. Your cleanroom is outfitted with HEPA filters directly adjacent to the return vents in the ceiling. This design may prevent the dilution of particle-laden air by HEPA filtered air. Therefore, your firm has no assurance of proper air circulation within your cleanroom where aseptic production occurs.11. Your production areas are difficult to clean and contain porous surfaces.12. Your facility is designed and operated in a way that may permit the influx of lesser quality air into a higher quality air area. Specifically, your cleanroom sliding glass doors have visible gaps that could compromise the integrity of the controlled environment. These openings create pathways for uncontrolled air movement and potential contamination transfer.13. Your firm handled hazardous drug products without providing adequate containment, segregation, or cleaning of work surfaces and utensils to prevent cross-contamination.14. Your firm produced drug products with materials that had not been verified to assure that they did not contribute endotoxin contamination that may be objectionable given the product’s intended use.FDA investigators also noted CGMP violations at your facility, that caused your drug products to be adulterated within the meaning of section 501(a)(2)(B) of the FDCA. The violations include, for example:1. Your firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes (21 CFR 211.113(b)).2. Your firm failed to establish an adequate quality unit and the responsibilities and procedures applicable to the quality control unit are not in writing and fully followed (21 CFR 211.22(a) and 211.22(d)).3. Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192).4. Your firm failed to establish a system for monitoring environmental conditions in aseptic processing areas (21 CFR 211.42(c)(10)(iv)).5. Your firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity (21 CFR 211.160(b)).6. Your firm failed to establish and follow written procedures prescribing a system for reprocessing batches that do not conform to standards or specifications and the steps to be taken to ensure that the reprocessed batches conform to all established standards, specifications, and characteristics (21 CFR 211.115(a)).7. Your firm failed to perform operations within specifically defined areas of adequate size and to have separate or defined areas or such other control systems necessary to prevent contamination or mix-ups in aseptic processing areas (21 CFR 211.42(c)(10)).8. Your firm failed to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality. Your firm also failed to validate and establish the reliability of your component supplier’s test analyses at appropriate intervals (21 CFR 211.84(d)(1) and 211.84(d)(2)).9. Your firm failed to prepare batch production and control records with complete information relating to the production and control of each batch of drug product produced (21 CFR 211.188).10. Your firm failed to exercise strict control over labeling issued for use in drug product labeling operations (21 CFR 211.125(a)).11. Your firm failed to establish written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(a)).12. Your firm failed to ensure that each person engaged in the manufacture, processing, packing, or holding of a drug product has the education, training, and experience, or any combination thereof, to enable that person to perform his or her assigned functions (21 CFR 211.25(a)).In addition, FDA investigators noted that your firm released and distributed several drug products in which the strength did not meet the label claim. For example, your firm released and distributed injectable methylcobalamin 5,000 mcg/mL, which was determined to have 65.3% the amount of methylcobalamin listed on the label, and injectable B Complex, which was determined to have 43.1% the amount of dexpanthenol listed on the label. Under section 501(c) of the FDCA [21 U.S.C. § 351(c)], a drug is deemed to be adulterated if it is unrecognized in an official compendium and its strength differs from, or its quality or purity falls below, that which it purports or is represented to possess. The strength of these compounded drug products differed from the strength represented on their labels, causing them to be adulterated under section 501(c) of the FDCA.Furthermore, FDA investigators noted your firm released and distributed a drug product that contained excessive bacterial endotoxins. More specifically, your firm initiated a complaint investigation after receiving a notification from a healthcare provider that three patients had developed adverse symptoms, including low blood pressure, uncontrollable shaking, shivers, and body aches shortly after or during the administration of a product compounded by your firm containing NAD+. According to the complaint report, these three patients received NAD+ Lot# GG121624-023 from the same vial and were directed to the emergency room. This product was compounded by your firm, but you did not perform any finished product testing prior to release. As part of your investigation, your firm sent the product in question to a contract laboratory for testing. An unopened vial from the same lot was found to contain excessive bacterial endotoxins with a reported value of 3,360 EU/mL. Under section 501(c) of the FDCA [21 U.S.C. § 351(c)], a drug is deemed to be adulterated if it is unrecognized in an official compendium and its strength differs from, or its quality or purity falls below, that which it purports or is represented to possess. Accordingly, your firm’s compounded product containing NAD+ is adulterated under section 501(c) of the FDCA.Outsourcing facilities must comply with CGMP requirements under section 501(a)(2)(B) of the FDCA. FDA’s regulations regarding CGMP requirements for the preparation of drug products have been established in 21 CFR parts 210 and 211. FDA intends to promulgate more specific CGMP regulations for outsourcing facilities. FDA has issued a revised draft guidance,Current Good Manufacturing Practice — Guidance for Human Drug Compounding Outsourcing Facilities under Section 503B of the FD&C Act. This draft guidance, when finalized, will describe FDA’s expectations regarding outsourcing facilities and the CGMP requirements in 21 CFR parts 210 and 211 until more specific CGMP regulations for outsourcing facilities are promulgated.Under section 301(a) of the FDCA [21 U.S.C. § 331(a)], the introduction or delivery for introduction into interstate commerce of any drug that is adulterated is a prohibited act. Further, it is a prohibited act under section 301(k) of the FDCA [21 U.S.C. § 331(k)] to do any act with respect to a drug, if such act is done while the drug is held for sale after shipment in interstate commerce and results in the drug being adulterated.Unapproved New Drug ProductsYou do not have any FDA-approved applications on file for drug products that you compound.5Furthermore, you do not have any FDA-approved applications on file for the drug products that you repackage, such as Semaglutide, Tirzepatide, and Retatrutide.6Under sections 505(a) and 301(d) of the FDCA [21 U.S.C. §§ 331(d)] a new drug may not be introduced into or delivered for introduction into interstate commerce unless an application approved by FDA under section 505 of the FDCA is in effect for the drug. Marketing of these products, or other applicable products, without an approved application violates these provisions of the FDCA.7In addition, you do not have any FDA-approved applications on file for certain other products that you manufacture, such as Thymosin Beta-4. Products such as Thymosin Beta-4 are unapproved new drugs under section 505 of the FDCA [21 U.S.C. § 355(a)] and also biological products under section 351 of the Public Health Service Act (PHS Act) [42 U.S.C. § 262]. In order to lawfully market a drug that is also a biological product, a valid biologics license application (BLA) must be in effect under the PHS Act. Your biological products, such as Thymosin Beta-4, are not the subject of an approved BLA. The introduction or delivery for introduction of these products into interstate commerce is prohibited under section 301(d) of the FDCA [21 U.S.C. § 331(d)].8Misbranded Drug ProductsYou compound drug products that are intended for conditions not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layman can use these products safely for their intended uses.You repackage drug products, such as Semaglutide, Tirzepatide, and Retatrutide, that are intended for conditions not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layman can use these products safely for their intended uses.You manufacture other products, such as Thymosin Beta-4, that are intended for conditions not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layman can use this product safely for their intended uses.Accordingly, the labeling of these products fails to bear adequate directions for their intended uses causing them to be misbranded under section 502(f)(1) of the FDCA.9In addition, the strength of compounded products, specifically injectable Methylcobalamin 5,000 mcg/mL and injectable B12 Complex, differed from and fell below their labeled strength. Under section 502(a) of the FDCA [21 U.S.C. § 352(a)], a drug is misbranded if its labeling is false or misleading in any particular. Because the labeling of these products is false, they are misbranded under section 502(a) of the FDCA.The introduction or delivery for introduction into interstate commerce of the aforementioned products violates section 301(a) of the FDCA. Further, it is also a prohibited act under section 301(k) of the FDCA to do any act with respect to a drug, if such act is done while the drug is held for sale after shipment in interstate commerce and results in the drug being misbranded.Failure to Report DrugsAs noted above, your facility failed to submit a report to FDA upon initial registration as an outsourcing facility in February 2025, and again in June 2025, identifying the drug products that you compounded during the previous 6-month period (section 503B(b)(2) of the FDCA). The failure to report drugs by an entity that is registered with FDA in accordance with section 503B(b) is a prohibited act under section 301(ccc)(3) of the FDCA [21 U.S.C. § 331(ccc)(3)].D. Corrective ActionsWe have reviewed your facility’s responses to the Form FDA 483. We acknowledge your firm has ceased drug production and distribution. We also acknowledge that on July 30, 2025, your firm initiated a voluntary recall of drug products intended or expected to be sterile, within expiry, due to lack of sterility assurance or microbial contamination.Your corrective and preventive actions (CAPA) and supporting documentation, including the deviation investigations, specific procedures, implementation plans, or timelines to address the violations, are inadequate. These documents lack sufficient detail regarding the actions you are currently taking to address each specific violation within the observations, including but not limited to your failure to expand your investigations to related and deficient practices. Furthermore, you have not provided documentation of these changes, including but not limited to approved revisions, qualifications, validations, training, or other corrective action plans.In addition to the issues discussed above, you should note that CGMP requires the implementation of quality oversight and controls over the manufacture of drugs, including the safety of raw materials, materials used in drug manufacturing, and finished drug products. See section 501 of the FDCA. If you choose to contract with a laboratory to perform some functions required by CGMP, it is essential that you select a qualified contractor and that you maintain sufficient oversight of the contractor’s operations to ensure that it is fully CGMP compliant. Regardless of whether you rely on a contract facility, you are responsible for assuring that drugs you produce are neither adulterated nor misbranded. [See 21 CFR 210.1(b), 21 CFR 200.10(b).]In addition, regarding issues related to the conditions of section 503B of the FDCA, we are unable to fully evaluate the following corrective actions due to lack of adequate supporting documentation:1. You state that you are “conducting a comprehensive review of all product formulations to verify that all raw materials, including bulk drug substances, are consistent with the requirements under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act).” You also state that “any in-house drug products that contain bulk drug substances subject to evaluation will be segregated and quarantined pending determination of the appropriate disposition under regulatory requirements and internal procedures” and that “a formal procedure will also be developed to ensure that all drug products and bulk drug substances are verified against section 503B requirements on an ongoing basis.” However, you have not provided documentation regarding the disposition of drug products containing 5-amino-1MQ (5-amino-1-methylquinolinium iodide) and NAD+ (nicotinamide adenine dinucleotide) or evidence that you have ceased compounding these products.2. While you acknowledge the importance of proper labeling and commit to developing procedures, your response lacks sufficient information. You have not provided a timeline for implementing corrective actions, stating only “TBD, depending on the timing of the(b)(4).” Additionally, you have not provided documentation demonstrating that your current labeling practices have been corrected.Regarding issues related to the conditions of section 503B of the FDCA, some of your corrective actions appear deficient:1. Your SOP for adverse event reporting does not adequately address adverse event reporting. For example:a. Your procedures do not adequately define what constitutes a “serious” adverse event;b. Your procedures do not define what constitutes an “unexpected” adverse event; andc. Your procedures do not adequately include a requirement to promptly investigate and submit a follow-up report regarding a serious, unexpected adverse event within 15 calendar days of receipt of new information or as requested by FDA.2. You have not submitted any report to FDA identifying the drug products that you compounded during the previous 6-month period.Should you continue to compound and distribute drug products that do not meet the conditions of section 503B, the compounding and distribution of your drugs would be subject to the new drug approval requirement, the requirement to label drug products with adequate directions for use, and the Drug Supply Chain Security Act requirements.FDA strongly recommends that if you decide to resume production of drugs your management first undertake a comprehensive assessment of operations, including facility design, procedures, personnel, processes, maintenance, materials, and systems. In particular, this review should assess your aseptic processing operations. A third-party consultant with relevant sterile drug manufacturing expertise should assist you in conducting this comprehensive evaluation.E. ConclusionThe violations cited in this letter are not intended to be an all-inclusive statement of violations at your facility. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.If you decide to resume operations to produce drugs, you should take prompt action to address any violations. Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to address any violations, or you may inform us that you do not intend to resume production of drugs. If you intend to resume production of drugs, please include an explanation of each step being taken to prevent the recurrence of any violations, as well as copies of related documentation. This letter notifies you of our concerns and provides you an opportunity to address them. If you believe your products are not in violation of the FDCA, include your reasoning and any supporting information for our consideration. In addition to taking appropriate corrective actions, you should notify this office fifteen (15) working days prior to resuming production of any drugs.All correspondence should refer to the Warning Letter Number above (# 718739) and include a subject line that clearly identifies the submission as a Response to Warning Letter. If you have questions regarding the contents of this letter, please contact compoundinginspections@fda.hhs.gov.Sincerely,/S/Matthew J. LashActing DirectorOffice of Compounding Quality and ComplianceOffice of ComplianceCenter for Drug Evaluation and Research___________________1See Pub. L. No. 113-54, § 102(a), 127 Stat. 587, 587-588 (2013).2We remind you that there are conditions, other than those discussed in this letter, that must be satisfied to qualify for the exemptions in section 503B of the FDCA.3These substances are also not eligible for the policy applicable to certain bulk drug substances described in the final guidance titled,Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act (Revision 1). This guidance describes FDA’s interim regulatory policy for outsourcing facilities registered under section 503B of the FDCA while the 503B bulks list is being developed. Specifically, the guidance sets out conditions under which FDA generally does not intend to take action against an outsourcing facility for compounding a drug product using a bulk drug substance that is not included on the 503B list where the drug product also does not appear on the drug shortage list in effect under section 506E at the time of compounding, distribution, and dispensing. These conditions include that the drug product appears on “503B Category 1 – Bulk Drug Substances Under Evaluation”, which includes substances that may be eligible for inclusion on the 503B bulks list, was nominated with adequate support for FDA to evaluate it, and has not been identified by FDA as a substance that appears to present significant safety risks pending further evaluation. For additional information, see the guidance at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM469122.pdf4For more information, see, FDA’s guidance, “Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act,” which can be found at https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM434188.pdf.5These specific products made by your firm are drugs within the meaning of section 201(g) of the FDCA [21 U.S.C. § 321(g)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases and/or because they are intended to affect the structure or any function of the body. Further, they are “new drugs” within the meaning of section 201(p) of the FDCA [21 U.S.C. § 321(p)] because they are not generally recognized as safe and effective for their labeled uses.6The products repackaged by your firm are drugs within the meaning of section 201(g) of the FDCA [21 U.S.C. § 321(g)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases and/or because they are intended to affect the structure or any function of the body. Further, they are “new drugs” within the meaning of section 201(p) of the FDCA [21 U.S.C. 321(p)] because they are not generally recognized as safe and effective for their labeled uses.7Drugs that are repackaged are not eligible for the exemptions for compounded drugs under sections 503A and 503B of the FDCA. For additional information, you may wish to review FDA’s 2017 guidance document, “Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities.” More specifically, the guidance sets forth conditions under which FDA does not intend to take action against drug products repackaged by pharmacies and outsourcing facilities for certain violations of the FDCA. Such conditions include, but are not limited to, the drug product that is being repackaged is a prescription drug product that (1) is approved under section 505 of the FDCA; or (2) is an unapproved drug product that appears on the drug shortage list in effect under section 506E of the FDCA, and the repackaged drug product is distributed during any period in which it is listed on that drug shortage list or during the 30 days following such period.8Biological products subject to licensure under section 351 of the PHS Act are not eligible for the exemptions for compounded drugs under sections 503A and 503B of the FDCA. For additional information, you may wish to review FDA’s 2018 guidance document, “Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application.” More specifically, the guidance sets forth conditions under which FDA does not intend to take action for certain violations of the FDCA when certain biological products are mixed, diluted, or repackaged in a manner not described in their approved labeling. This guidance addresses the mixing, diluting, or repackaging of a licensed biological product, not a biological product licensed for further manufacturing use only or a bulk drug substance. The policies expressed in this guidance do not extend to any person or entity that mixes, dilutes, or repackages a biological product from any other starting material.9Your compounded, repackaged and manufactured drug products are not exempted from the requirements of section 502(f)(1) of the FDCA by regulations issued by the FDA (see, e.g., 21 CFR 201.115).

Delivery Method:VIA Electronic MailProduct:Medical DevicesRecipient:Sean SaintChief Executive OfficerBeta Bionics, Inc.11 HughesIrvine,CA92618United States(b)(6)@betabionics.comIssuing Office:Center for Devices and Radiological HealthUnited StatesWARNING LETTERCMS #717927January 28, 2026Dear Mr. Saint:During an inspection of your firm located in Irvine, CA from June 9, 2025, through June 26, 2025, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures the iLet Dosing Decision Software and the iLet ACE Pump, which are part of the iLet Bionic Pancreas System. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.Quality System Regulation ViolationsThis inspection revealed that these devices are adulterated within the meaning of section 501(h) of the Act, 21 U.S.C. § 351(h), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at Title 21,Code of Federal Regulations(CFR), Part 820.We received responses from Neal Grant, Director, Quality Systems dated July 18, 2025, August 29, 2025, and October 29, 2025, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, that was issued to your firm. We address this response below, in relation to each of the noted violations. These violations include, but are not limited to, the following:1. Failure to adequately establish and maintain procedures for corrective and preventive action, as required by 21 CFR 820.100(a). For example:A. Your firm failed to adequately analyze quality data, such as complaints, to identify existing and potential causes of nonconforming product or other quality problems and utilize appropriate statistical methodology to detect recurring quality problems. For example:i. Your firm failed to implement corrective and preventive actions (CAPA) for complaints related to device malfunctions that led to serious adverse health outcomes, as required by Section 6.1.3 (Section 1.4 of Revs G and H) of your firm's corrective and preventive action procedure, Corrective and Preventive Actions, SOP05, Rev I, Section 6.1 (Section 6.6 of Rev I) of the firm's complaint handling procedure, Product Complaints, SOP13, Rev H, and Section 9 (Section 6.9 Rev I) of the firm's complaint handling procedure, Product Complaints, SOP13, Rev H.a. Investigators observed(b)(4)complaints reporting Faulty Motors, including one reporting the patient suffered Diabetic Ketoacidosis, confirmed by your firm to be device malfunctions, where you took no corrective actions and provided no justification for inaction, despite identified safety risks.b. Investigators observed(b)(4)complaints reporting hypoglycemic episodes that were attributed to Use Error – Unintended Insulin Delivery associated with the patients’ incorrectly changing the insulin cartridges. 107 complaints were submitted to the FDA as serious injury Medical Device Reports for severe hypoglycemia or intervention required to prevent severe hypoglycemia. Your firm's User-Related Risk Analysis, RA000021, identified that use errors with the iLet Bionic Pancreas System could trigger unintended insulin doses potentially large enough to cause death (classified as the highest risk level, Severity(b)(4)). Despite this identified safety risk, your firm closed 56 related complaints without implementing corrective actions to address the identified use errors or documenting justification for why corrective actions were deemed unnecessary.ii. Your firm conducts complaint trending through your risk management procedure, Risk Management Review, SOP 14.1, Rev B, Release Date 2023-03-13, to determine if escalation to corrective and preventive action (CAPA) is warranted. Your firm’s complaint trending process is inadequate, in that:a. Inconsistencies were observed between what your firm claims to analyze versus what is documented in your trending analysis. For example:1. Your firm’s complaint trending provided uses “As Reported Complaint Code: Term” and the part of the system (e.g., iLet device, luer connector, cartridge, etc.), but it does not trend complaints by “Complaint Conclusion” unless there was an associated MDR. Your firm’s Vice President of Quality Assurance stated that they also look at complaint conclusions on everything (with the exception of “not our product”) but that it was just not in the presentation.2. Multiple codes with identical or nearly identical meanings were found (e.g., "Use Error – User Did Not Announce Meals" vs. "User Error – Did Not Announce Meals"). Similar codes could dilute trending data for specific complaint types like meal announcements.b. Your firm uses multiple trending rates for complaint analysis that could lead to underestimation of meal announcement complaint rates, potentially affecting safety signals and risk assessment accuracy. For example: Your firm’s complaint trending uses trending rates, such as quantity of complaints per month and as a percentage of the total iLet shipments within a given time period. Your firm’s Vice President of Quality Assurance explained that they also use rates per opportunity. For example, users have approximately ten (10) opportunities to change their cartridge per month, so your firm will trend the percentage by(b)(4). A second example is that users have approximately 90 opportunities to meal announce (three times a day over 30 days), so your firm will trend the same as previous except(b)(4). Your trending rate for meal announcements (90 per month) is not representative of all users’ eating habits and as such might be affecting the rate at which your firm is trending meal announcement related complaints. In addition, your firm’s instructions state that “If you eat a very low carb diet or no carbs at all, you should not announce meals.”B. Your firm's verification of effectiveness (VOE) for CAPA 0050 is inadequate, in that, it tested(b)(4)employees on updated training materials, rather than actual iLet users, which was not representative of user population base (e.g. people 6 years of age or older with diabetes mellitus). Additionally, your CAPA 0050 does not address the allegations of hypoglycemia during the adaptation phase of initial use of the iLet.Your firm opened CAPA 0050 to investigate hypoglycemia allegations during the iLet Bionic Pancreas System's initial adaptation phase. Your firm determined that the root cause was users' inadequate understanding of diabetes management while using the device, leading to maladaptive behaviors and misuses. Your firm documented the related misuses in RA000021, Rev. E, User-Related Risk Analysis. Your firm initiated preventive actions for CAPA 0050, to include: 1) Holding office hours for health care providers; 2) Improving user training materials; 3) Creating information materials for users transitions from hybrid closed-loop systems and for users new to pump therapy; and 4) Improving guidance materials for health care providers.Additionally, Section 2.8.3 of your firm's corrective and preventive action procedure, Corrective and Preventive Actions, SOP05, Rev H, Release Date 2024-01-09, and section 1.1 of your firm’s work instruction, CAPA Process, WI000053, Rev C, Release Date 2024-01-09, state that an independent investigator and not the CAPA owner is responsible for executing the verification of effectiveness plan and documenting such activity. However, your firm’s CAPA owner also completed the verification of effectiveness activities for CAPA 0050.C. Your firm’s procedure, Corrective and Preventive Actions, SOP05, Revs G – I, states that CAPA requests are warranted for systemic issues that affect the quality of products or services, especially if: an incident caused injury or death; there are multiple occurrences of the same event, typically three within a rolling(b)(4)period; or a risk assessment identifies the issue as critical. Your firm failed to maintain records to demonstrate that the cause of nonconformities was investigated; the appropriate action(s) needed to correct and prevent recurrence of nonconforming product were identified; actions taken were verified or validated to ensure the actions were effective and did not adversely affect the products; changes in methods and procedures were implemented; and that information related to the nonconforming products was disseminated to those directly responsible for assuring the quality of the products or prevention of such products.Specifically, investigators observed 15 complaints (dated from July 2023 – December 2023) reporting damaged pump displays, where your firm's product evaluation confirmed the screens were bowed or delaminated. Per your firm’s System Risk Analysis, iLet Bionic Pancreas System, DeLorean (Insulin), RA000005, the risk to patients from being unable to read the display can result in hyper or hypoglycemia and is assigned a Severity of(b)(4)(Life-threatening serious injury that requires emergency professional medical intervention). Your firm implemented design changes to address these nonconformities (adding Vent to housing to vent internal volume of iLet to ambient pressure, per QP000171); however, no records were maintained to document any corrective actions or reference to CAPA records.D. Your firm failed to adequately document its investigation into device failures due to 5-minute delayed glucose readings instead of real-time data. Your associated Health Hazard Analysis, HHA-2024-002, dated 04/12/2024, states that this issue could potentially lead to the basal and/or correction controller not increasing insulin dosing for high or upward trending Continued Glucose Monitoring (CGM) values or the basal controller not reducing or suspending insulin based on downward trending CGM values. Reportedly, this issue was investigated in collaboration with your CGM supplier, resulting in your firm implementing a temporary software change on 04/05/2024 to mitigate patient risks, while your supplier implemented a permanent solution, however, your firm failed to document this investigation.We reviewed your firm’s responses dated July 18, 2025, August 29, 2025, and October 29, 2025, and conclude that they are not adequate. Your firm's assessment conducted in CAPA 0061 - CAPA VoE Review states, in relation to CAPA-0050, that the Verification of Effectiveness (VoE) was appropriate because it directly measured users' understanding after updated training, addressing the identified root cause, user knowledge gaps. The 100% pass rate on the assessment demonstrates that the revised training effectively improved comprehension related to safe iLet use. However, your firm also indicated in your response that you updated your VoE plan for CAPA-0050 and established a new plan to evaluate CGM-measured percent median time below 54 mg/dL in the user population before and after corrective measures implementation. Your success criteria was established as a(b)(4)% or greater reduction in percent median time below 54 mg/dL, which you state would indicate effectiveness of the corrective measures. Supporting evidence of new CAPA-0050 Verification of Effectiveness (VoE) plan was not provided. The root cause determination and verification of effectiveness criteria for CAPA-0050 is deficient in that it fails to distinguish between system design issues versus user training deficiencies and subsequently the preventive actions were solely focused on training improvements without addressing potential device design issues. It is not clear if an evaluation was made of whether the iLet's design of device (e.g. user interface, alert systems, or other potential design issues) could have contributed to maladaptive behaviors.2. Failure to adequately establish and maintain procedures for validating the device design to include an adequate risk analysis, as required by 21 CFR 820.30(g). For example:Your firm’s risk management procedure, Risk Management Review, SOP 14.1, Rev B, Release Date: 2023-03-13 states in Sections 1.2 – 1.3 that the Head of QA has overall responsibility for collecting and reporting post market feedback information to management to determine if the product is performing within the risk profile as determined by the products risk management documentation. The following sources provide information that is assessed against the associated risk management documentation: Management Review, Design Testing (non-clinical), Regulatory affairs information pertinent to the bionic pancreas, Nonconforming Material Reports (NCMRs), Manufacturing Data (e.g., yields), Complaints, Health Hazard Assessments, Competitor Information, Published Literature, Customer Feedback including surveys, Clinical Investigations and Follow up. The review of design, production and post market surveillance data and its assessment against the risk profiles per the related risk management documentation shall occur(b)(4), at a minimum.Your firm's System Risk Analysis, RA000005, for your iLet Bionic Pancreas, failed to include post-market risks identified through your firm’s complaint data, as required by your procedure. Specifically,A. Your firm has failed to incorporate known post-market safety data into your risk management processes.i. Investigators observed(b)(4)complaints, dated October 2024 – June 2025, reporting various malfunctions of the iLet Bionic Pancreas Model TA000036 caused by failure of the devices’ printed circuit board assembly manufactured by a supplier. Your firm’s risk analysis does not assess, or control identified hardware hazards.ii. Investigators observed two complaints, received on 02/07/2024, and 01/01/2025, reporting over infusion of insulin resulting in severe hypoglycemia or hypoglycemia requiring medical intervention where the users reported involuntary meal announcements. Your firm’s risk analysis fails to assess hypoglycemia risk from involuntary meal announcements.B. Your firm’s risk management procedure, Risk Management Review, SOP 14.1, Rev B, Release Date: 2023-03-13 states in Section 4 – Unanticipated Risks that as a result of the risk management assessment per this SOP, any unanticipated events are assessed based upon the severity and occurrence of the associated harm and hazard. This assessment includes a review of prior Design Verification Testing (DVT) and/or Process Validation activities to verify potential, applicable risk mitigations previously established. Rationale for non-escalation shall be documented in the RMRR and approved by the Head of Quality.Your firm has identified a hazard; however, the risk control implementation and validation are absent in your firm’s risk analysis. Specifically,Complaint # COM-0000000790 was reviewed reporting a patient with dementia gave themselves multiple successive meal boluses, although they were not eating. The following morning the patient’s blood glucose was 40 mg/dl. The caregiver attempted to wake the patient, but the patient was unresponsive. While your firm’s System Risk Analysis identifies that vulnerable populations (patients with diminished capacity), might be making inappropriate therapy decisions, resulting in hyper or hypo glycemia, your risk analysis fails to: 1) Document any risk control measures to address this specific hazard; 2) Demonstrate calculation of post-mitigation risks; 3) Show how the identified risk is being adequately controlled.C. Despite approximately 529 complaints reporting insulin cartridges or cartridge connectors leaking while in use, your firm's System Risk Analysis, RA000005, for the iLet Bionic Pancreas does not evaluate the risk to patients from cartridges and cartridge connectors leaking during use.We reviewed your firm’s responses dated July 18, 2025, August 29, 2025, and October 29, 2025, and conclude that they are not adequate. Your firm’s response states that you plan to update your risk management procedures; however, it does not address whether and how data sources from your firm’s quality system, such as complaints, CAPAs, nonconforming product, etc., will interface with your firm’s risk analysis process to determine if further corrective actions or regulatory decisions are required.3. Failure to adequately establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a).A. Your firm failed to adequately investigate complaints involving the possible failure of a device, labeling, or packaging to meet any of its specifications. For example:i. Investigators review of complaint data from June 2023 – June 2025 found over 500 complaints reporting iLet Bionic Pancreas system insulin cartridges or cartridge connectors leaking. The System Risk Analysis, iLet Bionic Pancreas System, DeLorean (Insulin), RA000005, does not identify the risk to patient from cartridge/connector leaks leading to under delivery of insulin to patients; however, the Risk Analysis identifies the risk of system under-delivery of drug resulting in hyper or hypo glycemia due to administration sets leaking as Critical - Results in permanent impairment of life-threatening injury.Your firm did not adequately address 31 complaints relating to cartridge or connector leaking. Specifically, your firm closed these complaints without investigation, concluding that no product deficiencies or defects were indicated, and that the complaints did not warrant an investigation. Additionally, by not investigating these product failures, your firm failed to recognize safety risks that could cause adverse events. For example, 18 of the 31 complaints (e.g., COM-0000007869, COM-0000007398, and COM-0000007157) reported that patients experienced hyperglycemic health effects.ii. Investigators observed that your firm failed to adequately investigate 21 complaints involving bent cannulas or infusion set failures associated with reports of diabetic ketoacidosis (DKA). Your iLet Bionic Pancreas System is distributed to customers with Convatec Inset and Contact Detach infusion sets manufactured for you by your infusion set supplier. Your firm is responsible for intake of complaints for the infusion sets and forwarding them to Convatec. Review of your complaint data shows that approximately 33% of the complaints in your complaint database are related to failure of the infusion sets, with the top failures reported as bent cannula, adhesive issues, and infusion set failures, and with 99.7% of the affected sets not returned by the customers. However, your firm did not request the sets to be returned for further investigation by your infusion set supplier.B. Your firm failed to implement and maintain adequate complaint files, per your procedures.Specifically, investigators observed that your firm had not adequately implemented your complaint handling procedure, Product Complaints, SOP13, Rev H, Release Date 2023-01-28, which requires review of all reported product experiences within(b)(4)to determine if they constitute a complaint.(b)(4)is the electronic quality management system, used by your firm. Your firm’s work instruction, WI000085, provides instructions for completing the product complaint process. Section 6 of work instruction WI000085, Revs A-C, state that if a complaint was created via(b)(4)(e.g., Case), various fields such as Event as Reported, Event Date, Aware Date, etc. will be auto filled into(b)(4). It also describes how new complaints can be directly entered into(b)(4).For example, your firm did not adequately address a user reported hyperglycemic event,(b)(4)Case 00015304, involving your iLet device. Specifically, on June 3, 2024, a user reported hyperglycemic event requiring emergency room treatment and insulin administration. On June 5, 2024, the user provided additional details including blood glucose reached 476 mg/dl, stayed high for over 4 hours, and patient developed diabetic ketoacidosis (DKA). On June 5, 2024, your firm closed the case without proper evaluation to determine if it required escalating to a product complaint or if it required reporting. Your firm’s Vice President of Quality Assurance confirmed this was a complaint on June 11, 2025.The adequacy of your firm’s responses cannot be determined at this time, as corrective actions are ongoing. Your firm has committed to implementing a new complaint handling system by October 29, 2025. Corrective actions, such as a retrospective review of complaints, are ongoing, and your firm did not provide complete evidence of implementation of your new complaint handling system. Without this documentation in hand, FDA cannot make an assessment with respect to adequacy. Please continue to send updates regarding the implementation of your corrective actions.4. Failure to adequately establish and maintain procedures to control product that does not conform to specified requirements, as required by 21CFR 820.90(a). For example:Your firm failed to adequately control product that does not conform to specified requirements. Firm's procedure for controlling nonconforming product is SOP09, Nonconformance Reporting.Nonconformance Report NCR #191 was opened after 61 out of(b)(4)iLet Bionic Pancreas printed circuit board assembly (PCBA) Mainboards failed testing due to faulty(b)(4)connections. Your firm claimed to have investigated with their supplier, your Vice President of Quality Assurance acknowledged that this investigation was not documented, and no corrective action was taken from the supplier, because this was considered a first-time issue. Your firm later received 19 customer complaints related to iLet Bionic Pancreas Model TA000036 failures caused by defective PCBA Mainboards with improperly installed components.We reviewed your firm’s responses dated July 18, 2025, August 29, 2025, and October 29, 2025, and conclude that they are not adequate. Your firm’s CAPA 0064 NCR/SCAR Review table shows instances where your firm has decided no SCAR is to be opened. The justifications for the following instances are inadequate:Components no longer active (i.e. Component is no longer active in current iLet (TA000048) configuration). It is not clear if these non-conformances still being tracked and adequately investigated. Your response does not address if there are devices in the field that still contain this component or if the supplier still provides components that are active. There are repeated instances in table where the same supplier has sent mixed lots of components, manufactured to incorrect part number or sent mislabeled components, but no SCARs were issued.Component manufactured to incorrect Part Number or Revision (i.e. the components were found manufactured to the incorrect part number. […] No SCAR will be issued as the parts were manufactured using equivalent materials. […] No additional NCRs were issued for a similar incident.)Damage during transportation (i.e. Damage to external shippers). It is not clear if these non-conformances still being tracked and adequately investigated.Typographical errors (i.e. Expiration Date on CoC was incorrect. […] The incorrect expiration on the CoC was a typographical error. The CoC was updated to the correct expiration date that was stated on the product.)Medical Device Reporting (MDR) ViolationsOur inspection also revealed that your firm’s iLet Dosing Decision Software and the iLet ACE Pump are misbranded under section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that your firm failed or refused to furnish material or information respecting the device that is required by or under section 519 of the Act, 21 U.S.C. § 360i. 21 CFR Part 803 - Medical Device Reporting was promulgated under section 519 of the Act, among other provisions. Significant violations include, but are not limited to, the following:1. Failure to report to the FDA the information required by 21 CFR 803.52 in accordance with the requirements of § 803.12(a), no later than 30 calendar days after the day that your firm received or otherwise became aware of information, from any source, that reasonably suggests that a device that it markets may have caused or contributed to a death or serious injury, as required by 21 CFR 803.50(a)(1). Manufacturers should submit a separate report for each device that it markets that may have caused or contributed to a death or serious injury. For example,A. The information included for Complaint COM-0000008592 describes an event in which a patient experienced hyperglycemia and chest pains while using your firm’s iLet Dosing Decision Software and was subsequently treated with IV fluids and Insulin. The IV fluids rehydrated the patient and corrected electrolyte imbalances, while IV insulin provided a way to lower the high blood sugar (hyperglycemia). If left untreated, chronic hyperglycemia can lead to diabetes complications, such as cardiovascular disease, nerve damage, eye disease and kidney damage. Based on the information included for the complaint and the medical intervention given to the patient, we determined that your firm’s device may have caused or contributed to a serious injury as defined by 21 CFR 803.3(w)(3). The medical intervention was necessary to preclude permanent impairment of a body function or permanent damage to a body structure. Therefore, this event meets the definition of a MDR reportable event under 21 CFR 803.3(o)(2)(i) because the serious injury was or may have been attributed to the iLet Dosing Decision Software, or the iLet Dosing Decision Software was or may have been a factor in a serious injury. Your firm became aware of the event on August 19, 2024, when you acquired the information in this complaint that reasonably suggested a reportable event had occurred. However, no MDR was received by the FDA.B. The information included for Complaints COM-0000025536, COM-0000026475, COM-0000026763, COM-0000003142 and COM-0000005866 describe adverse events in which patients experienced hypoglycemia with blood sugar levels below 70 mg/dL, while using your firm’s iLet Dosing Decision Software, and were treated with glucose drink or candies to raise their blood glucose level. We determined that treatment for hypoglycemia that includes glucose drinks or candies is a medical intervention necessary to preclude permanent impairment of a body function or permanent damage to a body structure because, if left untreated, hypoglycemia can lead to confusion, shakiness, dizziness, and weakness, but if severe and untreated, it can progress to serious complications like seizures, loss of consciousness (fainting), brain damage, coma, and even death. Repeated episodes can also cause reduced cognitive function, cardiovascular issues, and increased risk for future severe lows. Therefore, based on the information included for the complaints involving your firm’s device and the medical intervention given to the patients, we determined that your firm’s device may have caused or contributed to a serious injury as defined by 21 CFR 803.3(w)(3). Each of these events therefore meet the definition of an MDR reportable event under 21 CFR 803.3(o)(2)(i) because the serious injury was or may have been attributed to the iLet Dosing Decision Software, or the iLet Dosing Decision Software was or may have been a factor in a serious injury. Your firm became aware of the information included for Complaint COM-0000025536, which reasonably suggests a reportable event has occurred, on April 23, 2025, and FDA received the corresponding MDR 3019004087-2025-00443 on July 14, 2025, which exceeds the required 30-calendar day timeframe in 21 CFR 803.50(a). Your firm became aware of the information included for Complaint COM-0000026475, which reasonably suggests a reportable event has occurred, on April 30, 2025, and FDA received the corresponding MDR 3019004087-2025-00461 on July 9, 2025, which exceeds the required 30-calendar day timeframe. Your firm became aware of the information corresponding to Complaint COM-0000026763, which reasonably suggests a reportable event has occurred, on May 3, 2025, and FDA received the corresponding MDR 3019004087-2025-00581 on June 10, 2025, which exceeds the required 30-calendar day timeframe. Your firm became aware of the information corresponding to Complaint COM-0000003142, which reasonably suggests a reportable event has occurred, on April 1, 2024, and FDA has not yet received an MDR. Your firm became aware of the information included for Complaint COM-0000005866 on June 20, 2024, however, FDA has not yet received an MDR.2. Failure to report to FDA the information required by 21 CFR 803.52 in accordance with the requirements of § 803.12(a), no later than 30 calendar days after the day that your firm received or otherwise became aware of information, from any source, that reasonably suggests that a device that it markets has malfunctioned and this device or a similar device that your firm markets would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur, as required by 21 CFR 803.50(a)(2).For example, the information included for complaints COM-0000004919, COM-0000008065 and COM-0000008452 reasonably suggests that the firm’s iLet ACE Pump malfunctioned (e.g. component failures: memory chips,) while in use, meaning the device failed to meet its performance specifications or otherwise perform as intended under 21 CFR 803.3(k). Specifically, complaint COM-0000004919 describes an “Alert 60 - Bluetooth Communication” error, complaint COM-0000008065 describes a “Touchscreen unresponsive” error, and complaint COM-0000008452 describes a sleep/wake button unresponsive” error. Although the malfunction alerts reference different alert codes, each malfunction is associated with a defective hoverboard. A device malfunction that is associated with a defective hoverboard has previously resulted in a patient sustaining a serious injury. (Refer to complaint COM-0000003142). This prior incident demonstrates that such a malfunction (i.e., one that is associated with a defective hoverboard) is linked to a serious injury. It is reasonable to conclude that a recurrence of these malfunctions that are associated with a defective hoverboard would therefore be likely to cause or contribute to a serious injury. As such, the malfunctions listed in these complaints represent MDR reportable events for which MDRs must be submitted. Your firm became aware of Complaint COM-0000004919 on 5/25/2024, Complaint COM-0000008065 on 8/8/2024 and Complaint COM-0000008065 on 8/8/2024 however, based on our records, FDA has not yet received an MDR for each of the referenced malfunction events.The adequacy of your firm’s response dated July 18, 2025, cannot be determined at this time. In the response, your firm noted it initiated corrective actions to address the reporting issue, including a retrospective review of complaints received since June 2023. However, documentation of these corrective actions was not provided, as they are still ongoing.The adequacy of your firm’s response dated August 28, 2025, cannot be determined at this time. Your firm’s response dated August 28, 2025, is a periodic update and did not include any additional new information.The adequacy of your firm’s response dated October 29, 2025, cannot be determined at this time. Your firm’s response dated October 29, 2025, noted that your firm has a three-phase plan to address the reporting issue. However, documentation of the completion of these corrective actions was not provided, as they are still ongoing.In addition, the inspection revealed that your firm failed to adequately develop, maintain, and implement written MDR procedures as required by 21 CFR 803.17(a)(1). For example, during the inspection, your firm presented a document titled “Guidelines for FDA Reporting”, SOP 13.1, Rev. A, dated 2023-10-23, as its MDR procedure. After reviewing the procedure, we conclude that the procedure does not establish internal systems that provide for timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements, as required by 21 CFR 803.17(a)(1). For example, there are inadequate definitions of what constitutes a reportable event under 21 CFR Part 803. The fact that the procedure does not include a definition from 21 CFR 803.3 for the term “cause or contributed” may lead your firm to make an incorrect reportability decision when evaluating a complaint that may meet the criteria for reporting under 21 CFR 803.50(a).Your firm’s response dated August 28, 2025, appears to be adequate. In the response, your firm included a copy of its revised MDR procedure titled “Guidelines for FDA Reporting”, Documents Number: SOP 13.1, Rev. B, dated 2025-07-16, along with staff training records. Upon review, the revised procedures have adequately addressed the deficiency described above.Corrections and Removals Violation(s)Our inspection also revealed that your firm’s iLet Dosing Decision Software and the iLet ACE Pump are misbranded under section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that your firm failed or refused to furnish material or information respecting the device that is required by or under section 519 of the Act, 21 U.S.C. § 360i. 21 CFR Part 806 – Medical Devices; Reports of Corrections and Removals was promulgated under section 519 of the Act, among other provisions. Significant violations include, but are not limited to, the following:Failure to submit to the FDA within 10 working days of initiating a correction or removal a report required by 21 CFR 806.10. For example:A. Your firm discovered that the iLet Dosing Decision Software had failures regarding glucose values that were 5 minutes old (delayed readings), instead of using new readings as expected. The iLet Dosing Decision Software autonomously determines and commands an increase, decrease, maintenance, or suspension of all basal doses of insulin and autonomously determines and commands correction doses of insulin based on glucose readings, and it autonomously determines, and commands meal doses of insulin based on meal announcements. Use of the delayed glucose readings resulted in your iLet Dosing Decision Software not performing as intended, not dosing insulin to the patient and patient experiencing elevated blood glucose levels that presents a risk to health. Your firm implemented a software change/release version 1.4.4 to mitigate the risk to health posed by your iLet Dosing Decision Software. The new software version was uploaded to the cloud and made available to the customers for download on 4/5/2024. This action constitutes a medical device correction or removal initiated to reduce a risk to health posed by your device or remedy a violation of the Act caused by your device which may present a risk to health, under 21 CFR 806.10(a). You have not already provided this information as set forth in 21 CFR 806.10(f) (see 21 CFR 806.10(a)(2)), nor was the correction or removal action exempt from the reporting requirements under 21 CFR 806.1(b) (see 21 CFR 806.10(a)(2)). You were therefore required to submit a Report of Correction or Removal to FDA within 10 working days of initiation, under 21 CFR 806.10(b).B. Your firm discovered that the iLet ACE Pump had cybersecurity vulnerability for the Limited Access feature of the iLet Bionic Pancreas System, which is used as a security measure to prevent unwanted access to the pump controls. When either the lockscreen or Limited Access Passcode screen is viewed on the iLet display, other icons are present and active, and(b)(4). This results in unsecured access to change settings, including stopping insulin delivery or giving boluses inappropriately, both of which present a risk to health. Your firm implemented a software fix via DCO #3203 and released Software Version 1.4.3 on 3/26/2024. Beta Bionics sent an email to all customers on 4/1/2024, titled “iLet Software Update”, notifying them that Beta Bionics, Inc. released an iLet Bionic Pancreas Software update. This action constitutes a medical device correction or removal initiated to reduce a risk to health posed by the device or remedy a violation of the Act caused by the device which may present a risk to health, under 21 CFR 806.10(a). You have not already provided this information as set forth in 21 CFR 806.10(f) (see 21 CFR 806.10(a)(2)), nor was the correction or removal action exempt from the reporting requirements under 21 CFR 806.1(b) (see 21 CFR 806.10(a)(2)). You were therefore required to submit a Report of Correction or Removal to FDA within 10 working days of initiation, under 806.10(b).Your firm’s responses to the FDA-483, dated July 18, 2025, August 29, 2025, and October 29, 2025, are not adequate. For the issue related to delayed glucose readings described in paragraph A above, you categorized your action as a device enhancement, stating that the change was to improve a non-violative device’s safety or performance. Even if you categorized the software update as a “device enhancement,” the evidence still indicates that a report of correction or removal was required to have been submitted to FDA because you initiated the correction (i.e., updated the software) in order to reduce a risk to health posed by the device (i.e., inaccurate insulin dosing). The fact that the issue might have also involved a third-party CGM does not change the fact that you initiated the correction to reduce a risk to health posed by your device. Furthermore, there is no evidence that you designed and tested the iLet device to function with the particular CGM at issue.For the issue related to the cybersecurity vulnerability for the Limited Access feature described in paragraph B above, your firm alleges that the issue is non-reportable. We do not agree with this assessment. The evidence indicates that a report of correction or removal was required to have been submitted to FDA because you initiated the correction (i.e., updated the software) in order to reduce a risk to health posed by the device (i.e., prevent unsecured access to the pump controls).In addition, regarding your statement that your firm was conducting a Class III recall, we note that a recall’s classification is assigned by FDA, not the recalling firm (e.g., 21 CFR 7.3(m) and 7.41(b)), and that conducting a voluntary recall does not exempt a firm from the requirement to submit a report of correction or removal under Part 806 (e.g., 21 CFR 806.10(a)(2)). As explained above, you were required to submit a report of correction or removal to FDA.You have not submitted Reports of Correction or Removal to FDA as of 01/15/2026 for either of the failures listed above.Your firm should take prompt action to address any violations identified in this letter. Failure to adequately address this matter may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties.Other federal agencies may take your compliance with the FD&C Act and its implementing regulations into account when considering the award of federal contracts. Additionally, should FDA determine that you have Quality System regulation violations that are reasonably related to premarket approval applications for Class III devices, such devices will not be approved until the violations have been addressed. Should FDA determine that your devices or facilities do not meet the requirements of the Act, requests for Certificates to Foreign Governments (CFG) may not be granted.Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to address the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (which should address systemic problems) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm’s response should be comprehensive and address any violations included in this Warning Letter. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration as part of your response.Your firm’s response should be sent via email to CDRHEnforcement@fda.hhs.gov. Please include in the subject line, “CMS Case 717927” when replying. If you have any questions about the contents of this letter, please contact: Shaquenta Perkins at shaquenta.perkins@fda.hhs.gov.Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility or concerning your firm’s devices. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of any violations and take prompt actions to address any violations and bring the products into compliance.Sincerely,/S/Barbara C. MarsdenActing DirectorOffice of Regulatory ProgramsOffice of Product Evaluation and QualityCenter for Devices and Radiological Health

Delivery Method:VIA Electronic MailProduct:Medical DevicesRecipient:Monica F. AbelesOwner and PresidentDiasol, Inc.310 S. 43rd Ave., Ste. BPhoenix,AZ85009United States(b)(6)@diasol.comIssuing Office:Center for Devices and Radiological HealthUnited StatesWARNING LETTERCMS #719460January 29, 2026Dear Ms. Abeles:During an inspection of your firm located in Phoenix, AZ from July 21, 2025, through August 19, 2025, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures disinfectants used to disinfect dialysate delivery systems and water purification systems used in hemodialysis (i.e. Diasol Bicarb, Diasol Concentrate, Diasol Additives, and CirtiSol Concentrate) for treatment of patients with renal failures or toxemic conditions. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or are intended to affect the structure or function of the body.Unapproved Device ViolationOur inspection revealed that your solutions of Citric Acid in 50% and 20% concentrations indicated for use in the cleaning, decalcification, and heat disinfection of hemodialysis machines are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not for these devices have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g). These devices are also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), because your firm did not timely notify the agency of its intent to begin the introduction or delivery for introduction into interstate commerce for commercial distribution of the devices, as required by section 510(k) of the Act, 21 U.S.C. § 360(k). While you do have a clearance under section 510(k), K020231, for a Citric Acid product intended for use with sorbent regenerated dialysis to allow physicians to customize the dialysate to meet patients’ needs, that product is not intended for use in the disinfection of hemodialysis machines. Accordingly, you were required to submit a premarket notification (510(k)) for your solutions of Citric Acid in 50% and 20% concentrations indicated for use in the cleaning, decalcification, and heat disinfection of hemodialysis machines (see 21 CFR 807.81(a)(3)(ii)).For a device requiring premarket approval, the notification required by section 510(k) of the Act, 21 U.S.C. § 360(k), is deemed satisfied when a PMA is pending before the agency. [21 CFR 807.81(b)(1)(i)]. The kind of information that your firm needs to submit in order to obtain approval or clearance for the devices is described on the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm. The FDA will evaluate the information that your firm submits and respond as appropriate.Quality System Regulation Violation(s)This inspection revealed that these devices are adulterated within the meaning of section 501(h) of the Act (21 U.S.C. § 351(h)), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820.We received your email responses dated September 10, 2025, October 8, 2025, and November 21, 2025, concerning our investigator’s observations noted on the Form FDA 483, List of Inspectional Observations (FDA 483) that was issued to your firm on August 19, 2025. We address the responses below, in relation to each of the noted violations. These violations include, but are not limited to, the following:1. Failure to adequately establish procedures for finished device acceptance, as required by 21 CFR § 820.80(d).Specifically, according to your procedure for Final Acceptance, SOP 80.001, Rev. 03, your firm did not adequately implement final testing activities. For example:A. Your firm claims compliance to following(b)(4)(currently(b)(4)). The standard requires all electrolytes identified on the label must be within(b)(4)of the labeled value, except sodium, which must be within(b)(4), or(b)(4), whichever is greater. However, the acceptability range in your DMR and Device History Records (DHRs) does not meet this requirement. For example:i. The acceptable range for formulations with 1K Potassium is(b)(4)mEq/L per the standard; however, your firm’s specified range for 1K Potassium is established at(b)(4)mEq/L, as documented in your DMR and DHRs. Nine (9) DHRs reviewed from March 2024 to July 2025 for dialysate acid concentrate products labeled as having(b)(4)mEq/L of Potassium showed that they were released with Potassium concentration results of(b)(4)mEq/L, which exceeds the acceptable range in(b)(4)standard of(b)(4)mEq/L.ii. According to(b)(4)standard, the minimum acceptable level of Calcium should be(b)(4)mEq/L; however, your firm’s acceptance criteria for formulations requires(b)(4)mEq/L of Calcium, set between(b)(4)mEq/L as documented in your DMR and DHRs. Out of 23 Device History Records (DHRs) reviewed from March 2024 to July 2025 for acid concentrate labeled as(b)(4)mEq/L of Calcium, 15 DHRs were released with Calcium results at(b)(4)mEq/L, which is below the allowed range established by the(b)(4)standard.B. Your firm’s In-Process and Final Batch Testing Procedure, WI 80.004, Rev. 3 and the procedure for Final Acceptance, SOP 80.001, Rev. 3, requires that Dextrose (Glucose) is tested on the(b)(4)container for each batch in accordance with the specifications in your Device History Records (DHRs). Your firm did not implement these procedures or its process for releasing finished products. Your firm released 4 out of 34 DHRs without Dextrose (Glucose) test results. Your firm began distributing three batches (Batch #’s 3170, 3168, and 3166) of the Diasol Acid Concentrates without Dextrose results on 7/14/2025; and one batch (Batch #DCS16) of the Dry Citrisol product without Dextrose result on 08/05/2025.Your response is inadequate. We understand that you entered into an agreement with(b)(4)to perform testing side-by-side with other labs such as(b)(4)and(b)(4)to determine the test result error for specific flagged batches, or to determine if it is your firm’s production error, with the electrolyte ranges not meeting the(b)(4)standard. Your firm should also recognize that your specification ranges are not compliant, instead of solely concentrating on determining if the laboratory testing method ((b)(4)method) is accurate. You should demonstrate that your specifications meet the relevant(b)(4)standard your firm has selected to follow and FDA requirements for their intended use. The lab-to-lab comparison studies should be reviewed in combination after updating your Device Master Records (DMRs) to comply with(b)(4)standard. Your firm should confirm which specific analytical methods the labs use to ensure adherence to the standard.Please provide documented evidence that your firm is committed to updating your DMRs to comply with the applicable standards. You should be specific in your Final Acceptance Procedure and DMR/DHRs that the electrolyte ranges are compliant. Your firm should not use the current non-compliant electrolyte ranges pending additional testing. Changing laboratories may not address the main problem that your specifications do not meet the required(b)(4)standard. All electrolyte ranges should reflect the requirements of the standard you have chosen to follow. Finally, all results for the batches noted in the FDA 483 for observation 1A, should be reviewed to conform with the(b)(4)standard.Furthermore, regarding observation 1B, we understand that you are performing glucose testing on retained samples from the affected lots and your procedures (WI 80.004 and SOP 80.001) have been updated to include QA review and signoff for glucose testing prior to release. Also, you have planned to conduct(b)(4)audits of DHRs and batch release documentation and conduct CAPA effectiveness review. Please provide evidence of these corrective actions. Your firm should provide justification demonstrating how weight verification substitutes for chemical testing requirements for glucose content or perform the required chemical testing. Without such written justification, your response is inadequate. Furthermore, you may need to reassess the risk analysis if you find that this testing substitution was inadequate for glucose content.2. Failure to adequately validate a process whose results cannot be fully verified by subsequent inspection and test according to established procedures, as required by 21 CFR § 820.75(a). Specifically,A. Your firm conducted a cleaning validation for the re-usable(b)(4)drums under Drum Cleaning Validation (Protocol #75.007, dated 09/04/2019). The reusable(b)(4)drums are cleaned with(b)(4)water using a(b)(4)prior to filling them with a new batch of acid concentrate after they are returned from your customers and stored in your warehouse for an undetermined amount of time. The cleaning validation and re-validation of the drums are inadequate. For example,i. The study did not demonstrate there are no chemical residues from the earlier batches to prevent cross contamination. These drums are used to package and distribute Diasol and Citrisol acid concentrates that are made with differing raw materials such as acetic acid and citric acid. Also, the study does not evaluate that the reusable drums can be re-used indefinitely considering the processes, reuse, storage and solvents used in these drums.ii. The Validation Report generated on 10/07/2019 was not accompanied by the raw data for drums(b)(4)to support the conclusion presented, and the data could not be provided upon investigator’s request.iii. Data for re-validation dated 10/09/2020 using(b)(4)drums showed conductivity and pH tests failed on all(b)(4)drums after wash. There was no documented deviation or evidence of an investigation of these failures.iv. Re-validation data of(b)(4)drums dated 07/19/2021 did not include total plate count results for microbiological testing on 4 of the(b)(4)drums after wash.Also, your firm’s Work Instruction, Drum Washing, WI 70.003, Rev. 2, requires re-validation of the washing method(b)(4)but no revalidation has been conducted since 2023.B. Your firm utilizes both a(b)(4)and a(b)(4)mixing tank to mix dialysate acid concentrates. The validation protocols and reports (#75.005 and #75.006) for the mixing process for(b)(4)tanks are inadequate. For example,i. The mixer speed is one of the six key parameters for homogeneity of the finished product, according to your mixing validation but neither the protocol nor the report specifies the mixing speed of the tank mixers.ii. Temperature is stated to affect mixing time in the batch production work instruction (WI 70.007, Batch Assembly, Rev. 2), and all lots produced for both validations show(b)(4); however, there is no specified acceptable temperature range or assessment of the duration of mixing affects the quality of your product.iii. Sample sizes are not justified in multiple testing areas for your products while mixing. There is no rationale for the sample size and the method of collecting(b)(4)from the(b)(4)of the mixing tanks to determine homogeneity of the batch during this mixing validation. Currently, your firm collects three production samples from the(b)(4), and(b)(4)to test the composition of the dialysate concentrate. However, the glucose level is(b)(4). This practice of using(b)(4)production samples was not included in your mixing process validation to demonstrate your batch is uniform across all filled(b)(4).iv. The reports state that longer mixing times does not affect the batch, but your firm did not provide adequate scientific rationale with supporting evidence for the maximum mixing time, or how you reached this conclusion.Additionally, the mixing validation for the(b)(4)tank confirmed the mixing process with a mixer and a recirculation pump; however, the mixer in the firm’s(b)(4)mixing tank has not been operational since around 2022, and since then, the batches have only been mixed using the recirculation pump system, but this new mixing process has not been validated.C. The(b)(4), which was installed in your facility in(b)(4)to produce water for dialysate concentrate was not adequately validated. For example, your firm could not show that components were installed as per the piping and instrumentation diagram; that controls and alarms were configured correctly, and that critical process parameters and their operating ranges were properly established and controlled. Your firm could not provide a schematic showing how the components were installed and how the specifications for the operating parameters were determined.D. Your firm conducts total viable counts to monitor the microbiological quality of the(b)(4)water used to prepare dialysate concentrates, following the Microbiological Testing Procedure, WI 80.002, Rev. 5 using(b)(4)plate technique on(b)(4)plates incubated at(b)(4)for(b)(4). However, in practice your firm has incubated(b)(4)plates for up to(b)(4)at temperatures up to(b)(4). This test method has not been validated to confirm its effectiveness in recovering microorganisms from the(b)(4)water samples.The adequacy of your response cannot be determined at this time. We understand you developed a new drum cleaning validation protocol and report (SOP No. 75.007, Rev. 2).You also agreed to implement related procedures, perform retrospective review and CAPA for failed pH/conductivity tests and missing microbial data, conduct re-validation of cleaning process using newly installed(b)(4), retrain employees on cleaning procedures, and schedule(b)(4)audits to ensure compliance with cleaning validation procedures. Please ensure that you have addressed any cross-contamination risks between Diasol and Dryasol (Acetic Acid), and Citrisol (Citric Acid) products for using reusable drums. Your firm claims that life span of the(b)(4)drums is between(b)(4), but cleaning validation should still evaluate the effect on containers when deterioration is anticipated. There is no raw/historical data for drums(b)(4)to support the validation report generated on 10/7/2019, but your firm plans to implement SOPs for retention and traceability of raw validation data.Regarding observation 2B, your CAPA plan involves carrying out new mixing validation runs for each tank using the mixer and recirculating pump separately. Your firm is planning to conduct in-process and final acceptance testing on samples and assessing homogeneity by taking samples and conducting analytical tests (pH, conductivity, and concentration). Also, you’ve stated you plan to retrain QA and validation personnel on the revised documentation. Please ensure that you have documented the actual mixer speeds used when conducting the validation studies which appears to be the main issue with the process parameters (omitting the mixer speed in your previous validation report). The mixer speed is a critical parameter that directly impacts the homogeneity and consistency of dialysate acid concentrates. Your firm claims that temperature variation has minimal impact on your mixing process and that you have little control over(b)(4)water temperature(b)(4). A lack of control over the water temperature does not eliminate validation requirements. Your firm should include acceptable ranges prior to executing your validation because temperature is a critical parameter among pH, conductivity, specific gravity, and mixing time. The adequacy of this response cannot be determined at this time.Regarding observation 2C, your firm committed to ensuring that all water purification systems meet expectations for validation, documentation, and control. Your response stated that the(b)(4)installation and setup followed the manufacturer’s guidelines and that all(b)(4)parameters and(b)(4)log were configured according to the manufacturer’s instruction for starting the(b)(4)water system. Your firm claims that these requirements and the drawing of(b)(4)components are adequate. The(b)(4)manufacturers guidelines do not substitute for formal validation protocols (IQ/OQ/PQ). You should demonstrate that the validation requirements are met, ensuring that the water system is suitable for your use and complies with the specifications, in addition to installation adhering to the manufacturer’s guidelines. Also, your(b)(4)water system has been in use since(b)(4)without proper validation which represents(b)(4)years of unvalidated operations. The adequacy of this response cannot be determined at this time since corrective actions are in progress.Regarding observation 2D, your firm’s CAPA plan is for all microbial testing of(b)(4)water to revert to the validated method outlined in your Microbial Testing (WI 80.002. Rev. 5) procedure. You stated a formal study will be conducted to assess the impact of the modified method, and that the validation will follow USP 61, USP 62, and(b)(4)guidelines. Also, your procedure will be revised if the modified method is successful and is validated. Your firm said that your incubators with temperature spike occurred because an air conditioner in the facility broke down causing the temperature to rise, and the QC operator did not know how to lower the temperature. The environmental explanations do not justify using unvalidated methods and you should have stopped testing until the conditions were corrected. Your firm claims that temperature spike was resolved “2 days later” and your firm purchased “(b)(4)new incubators” and will assess plates for impact. Your firm has not addressed why you continued to use the(b)(4)plates that were held outside labeled conditions or did not provide validation for the modified conditions. The adequacy of this response cannot be determined at this time as corrective actions are in progress.3. Failure to adequately establish process control procedures that describe any process controls necessary to ensure conformance to specifications, as required by 21 CFR § 820.70(a). Specifically,A. Your firm has not adequately implemented its procedure for Microbiological Testing, WI 80.002, Rev. 5. The microbiological sampling and testing of(b)(4)water, which is used to prepare the acid concentrate products, has not been adequately implemented due to the following conditions: For example,i. The exact location of the sampling port location for collecting the(b)(4)water and the identity of the person collecting samples are not documented. The(b)(4)water sample is taken from one of(b)(4)sampling ports.ii. The sampling port used on the(b)(4)water system does not represent actual point-of-use conditions where the water will be utilized in manufacturing.iii. Samples are collected using non-sterile containers, introducing potential contamination that could affect test results.iv. Samples are plated using non-sterile(b)(4)syringes that expired in June 2016.v. The incubator temperature for incubating the(b)(4)plates to measure the total microbial count of the(b)(4)water sample should be maintained between(b)(4). On 07/21/2025 and 07/24/2025, the thermometer showed temperatures of 41°C and 42°C on 07/23/2025, respectively.vi.(b)(4)plates from(b)(4)samples are read on the(b)(4), exceeding the required incubation at(b)(4)for(b)(4).vii. The Laboratory Record-Culture Reading sheets do not include the start and end times for incubation, which makes it impossible to confirm that the minimum requirement of(b)(4)has been met.viii. The Laboratory Record-(b)(4)sheets reviewed for endotoxin tests lack the start and end times for incubation, which does not show compliance with the necessary incubation periods.B. The monitoring and disinfection of the(b)(4)is not being conducted appropriately per the(b)(4)and(b)(4)Instructions for use and Maintenance, WI 70.001, Rev. 2 For example, your procedure requires(b)(4)monitoring of specific parameters including pressures, flow rates, water quality measurements (TDS, pH, conductivity, hardness), and system performance metrics, whereas:i. The temperature, conductivity, pH, prefilter outlet pressure, and reject % of the(b)(4)water system currently used to manufacture the acid concentrate products is not being adequately monitored(b)(4). A review of the(b)(4)for 2024 and 2025 found the pH and conductivity of the(b)(4)water has not been measured(b)(4), the temperature is not a monitored parameter, the(b)(4)has not been documented as the gauge is broken, and the feed conductivity and Reject % has not been monitored since the(b)(4)water system panel has not worked since on or about 06/21/2022.ii. The disinfection process fails to include the complete(b)(4)water system. The pipes carrying(b)(4)water to mixing tanks and washing areas are not included in disinfection procedures, creating potential microbial contamination pathways that could compromise product quality.C. The temperature of the warehouse where finished product and raw materials are stored is not monitored adequately per your procedure, Facility Maintenance - Cleaning and Pest Control, WI 71.002, Rev. 2. For example,i. WI 71.002 specifies air conditioning settings of(b)(4)(summer) and(b)(4)(winter), but the Temperature Log (WI Form 71.002) allows an "Acceptable Range" of(b)(4). There is no documented rationale, or testing to support storage of finished products at temperatures up to(b)(4). Also, the USP grade raw material labels require that Potassium Chloride is kept in “dry and room temperature” storage conditions; Calcium Chloride require “cold, dry” storage conditions; and Citric Acid requires “dry, cool” storage conditions.ii. Warehouse humidity is not measured despite raw materials requiring dry storage conditions.iii. Per SOP 72.001, Rev. 1, calibrated thermometers are required for monitoring warehouse temperatures; however, uncalibrated thermometers are used in where raw materials are stored and dispensed in the warehouse without proper temperature control.iv. Temperature is only measured at one location outside the mixing area, but the facility is approximately(b)(4)square feet and has multiple designated storage areas for raw materials and finished products. The different storage areas have independent HVAC systems but lack individual monitoring.On 7/29/25, the investigators observed the thermometer in the warehouse showed 90°F, while the mixing room near the drum filling areas reached 98°F. The temperature in the warehouse, where the finished products are stored prior to loading trucks, is not monitored. It was also observed the bay door was open on most days during the inspection, with outside temperatures reaching over 100°F.The adequacy of your response cannot be determined at this time. Regarding observation 3A, we acknowledge that your firm initiated a CAPA plan to address microbiological testing procedures and(b)(4)water system standardization. These include revision of Microbiological Testing procedure (WI 80.002, Rev. 5) to require proper documentation of sampling ports, and implementation of standardized(b)(4)water system protocols. Your firm agreed to update your sampling location by transition from using the "farthest point" to identifying true point-of-use locations for(b)(4)water sampling. Your firm should demonstrate the requirements to validate new sampling locations to ensure they are truly representative of actual use points. You should also establish specifications that clean(b)(4)should be used when adding(b)(4)water samples to(b)(4)plates and ensure that sterile equipment is mandatory for contamination control principles and the use of expired syringes should not be allowed. Despite your equipment upgrades and procedural improvements, we recommend that while the immediate technical issues may be resolved, the root cause of the monitoring and detection failures has not been adequately addressed.Regarding observation 3B, your firm has committed to repairing the broken pressure gauge and restoring(b)(4)water system panel functionality. You stated that you have hired a third-party to conduct a comprehensive system audit to identify additional potential failures, along with employee retraining on updated SOPs and implementation of a preventive maintenance schedule. Please explain the 3-year delay in addressing the(b)(4)panel failure that has existed since 2022. There is no proper justification why(b)(4)monitoring of the(b)(4)water system was not maintained, identified, or corrected during the equipment failure period. Also, we understand that you have taken corrective actions to address disinfection protocols for your entire(b)(4)water system. Please revise your(b)(4)-004 to include a full system disinfection procedure, covering all piping, valves, and endpoints. Finally, you indicated that training will be provided to employees on updated procedures and implement a verification checklist to ensure all components are disinfected. Your response cannot be adequately determined without a follow-up inspection to verify the repairs you completed at your facility.Regarding observation 3C, your firm has implemented corrections to address the temperature in the warehouse where finished product and raw materials are stored. Please provide adequate evidence demonstrating proper relocation of temperature-sensitive materials to cooler conditions per USP requirements and any evaluation of the products left over that had been stored there. There is lack of justification for storage of temperature-sensitive raw materials requiring "cold, dry" or "cool, dry" conditions. The adequacy of this response cannot be determined at this time. Please provide supporting documents and detail the actions taken to resolve the improper storage of your products and raw materials, as well as documentation demonstrating actions you have taken to address the temperature and humidity issues.4. Failure to appropriately design, construct, and install equipment used in the manufacturing process to facilitate maintenance, adjustment, cleaning, and use, as required by 21 CFR § 820.70(g). Specifically,The following conditions of your production equipment were observed throughout the inspection. For example,A.(b)(4)water system(b)(4)is used to manufacture the Diasol products, and Citrisol Acid Concentrates, and Citric Acid. The inspection found deficiencies including:i. Water leaking from(b)(4)housing and hoses, creating potential contamination risks.ii. The(b)(4)water system control panel is inoperable eliminating the ability to monitor critical water quality parameters (conductivity, reject percentage)iii. 12-inch dead leg in water piping to mixing tanks and drum washing area can harbor microbial growth.iv. Missing the(b)(4)pressure gauge needle, bent and inoperable pump feed pressure gauge, and uncalibrated gauges and flowmeters throughout the system.B. The mixing and drum filling area deficiencies include:i. Leaking pipefitting at base of(b)(4)tank in the filling line for dialysate acid concentrates.ii. Inoperable motor for(b)(4)tank mixing blades, forcing reliance solely on recirculating pump for mixing.iii. Drum filling hose observed touching the floor during operations.iv. Both electrical control panels are inoperable including flow meter displays for both(b)(4)and(b)(4)tanks.C. It was observed that the conditions of the equipment in the drum washing area raised contamination concerns. The drums are cleaned with(b)(4)water using a(b)(4)before they are used, and the caps are cleaned by placing them in a bucket filled with(b)(4)water before use. For example:i. Hoses and(b)(4)hose are stored inside water-filled bucket creating potential for microbial growth and cross-contamination.ii. Washing hoses observed touching the floor are compromising cleanliness of equipment used for container preparation.The adequacy of your response cannot be determined at this time. Your firm acknowledged several equipment deficiencies related to improper design, maintenance, and installation that hindered effective cleaning, adjustment, and operation. You stated for observation 4A and 4B that all leaking components are being replaced with(b)(4)housing, hoses inspected, and replacement parts requested from your supplier.The damaged gauges have been replaced with new units and a 12-inch dead leg will be removed and piping reconfigured to eliminate stagnant water zones. In addition, your firm plans to conduct(b)(4)PM checks, and employees will receive retraining on equipment inspection and reporting protocols. Your procedures will be revised to include(b)(4)water system monitoring and maintenance procedures. Your firm indicated there is difficulty locating replacement boards for the(b)(4)panel and plans to continue(b)(4)readings.However, you have not addressed a timeline for obtaining replacement(b)(4)panel board versus indefinite(b)(4)operation. It is unclear what is your current method for monitoring conductivity and reject percentage if the(b)(4)water system remains operational. We cannot verify the calibration status of your newly installed gauges and flowmeters at your facility. Please provide supporting documents to verify that the actions mentioned above have been implemented, along with the timeline, the method used to monitor the water quality parameters, and the calibration status of your new measuring equipment.Additionally, your responses indicate that equipment issues and corrective actions will also address pipe fitting at the base of the(b)(4)tank which was replaced and pressure tested. The hose holders were installed to prevent floor contact, and SOPs were updated to include hose sanitation protocols. Your firm stated the mixing motor requires replacement and validation, but currently mixing is performed using a(b)(4)with(b)(4)testing of each batch to ensure homogeneity. The electrical systems are under repair requiring(b)(4)filling operations. Some of the concerns we have with your corrective actions is that you have no plan to repair or replace critical monitoring equipment, claiming it's unnecessary. There is no specific timeline given for replacing critical equipment such as the(b)(4)tank motor. Additionally, we have concerns about the temporary(b)(4)mixing method, including how(b)(4)testing guarantees batch homogeneity without proper validation protocols. The adequacy of your response cannot be determined at this time. Please address our concerns stated above and provide supporting documentations to verify the adequacy of your corrective actions.Regarding observation 4C, your firm stated that all hoses were removed from water buckets to eliminate improper storage. The wall-mounted hose hangers were installed with drip trays beneath to prevent water pooling. Sanitation procedures were revised to include instructions prohibiting hose submersion, with visual aids and diagrams for proper storage. You state employee training will be conducted, and(b)(4)sanitation checks will now include hose storage verification. Per your firm’s Work Instruction #70.003,(b)(4)water buckets they are now designated solely for soaking drum caps (maximum(b)(4)), with water changed every(b)(4). Your firm claims hoses were removed from water buckets but then describes continued use of(b)(4)water buckets for drum cap soaking for up to(b)(4). Your corrective actions focus on hose hangers but fails to adequately address the fundamental contamination risks associated with improper hose storage. No detailed assessment was provided regarding duration of improper hose storage, potential impact on product quality, products already released using this practice, and your current actions to effectively eliminate contamination risks.The adequacy of your response cannot be determined at this time. Please address our concerns stated above and provide supporting documentations to verify the adequacy of your corrective actions.5. Failure to suitably design buildings to perform necessary operations, as required by 21 CFR § 820.70(f).Specifically, the following conditions were observed at your facility.A. The floors in mixing, gallon filling, and washing areas show erosion and pitting that creates areas where water can accumulate.B. The washing area wall where drums are cleaned shows multiple problems including moisture damage, structural deterioration, and apparent mold growth on tiles.C. Two doors were improperly secured - the wash area exterior door was not fully closed and the warehouse bay door (where finished product is stored) remained open during operations.Your response for observation 5A and 5B is inadequate. Your firm proposed corrective and preventative actions to address the inadequate conditions of your facility. However, we are concerned that your firm plans to use the same chemical-resistant epoxy polyurethane solution that has already failed multiple times since 2019. There is no mention of concrete repair or proposed surface preparation before recoating. The salt erosion from your products may continue damaging the concrete substrate of your facility and purchased repair products have not been evaluated to determine adherence to existing damaged concrete. There are no established procedures for addressing the black mold-like substance or underlying moisture problems and no proposed ventilation improvements or containment systems to prevent future damage.In addition, please evaluate the impact of open doors at your facility on environmental controls, specifically how door breaches affect temperature, humidity, and contamination control in the manufacturing environment. This may have broader implications on your firm’s manufacturing processes and product quality. The adequacy of your response for observation 5C cannot be determined at this time.6. Failure to adequately establish procedures to control product that does not conform to specified requirements, as required by 21 CFR § 820.90(a). Specifically,Your firm did not adequately implement procedures for Nonconforming Product, SOP 90.001, Rev. 5, and Final Acceptance, SOP 80.001, Rev. 3. For example:A. You did not initiate Product Nonconforming Reports (PNCRs) when chemical laboratory out-of-specification (OOS) test results failed to meet specifications during final acceptance testing or investigate the root causes of these failures. For example,i. Diasol acid concentrate Batch(b)(4)(Lot(b)(4)) failed specifications for both Dextrose (92 mg/dL compared to allowable range(b)(4)mg/dL) and Calcium (2.30 mEq/L compared to allowable range(b)(4)mEq/L) tested on 6/28/2025.ii. Citrisol acid concentrate Batch(b)(4)(Lot(b)(4)) failed Dextrose specification (92 mg/dL compared to allowable range(b)(4)mg/dL) on 6/28/25.iii. Diasol acid concentrate Batch(b)(4)(Lot(b)(4)) failed Magnesium specification (1.15 mEq/L compared to allowable range(b)(4)mEq/L) on 5/27/25.In all cases, your firm said new samples were submitted for re-testing and re-tests eventually passed. However, your original failed results were excluded from the DHR and no PNCRs were initiated to investigate the causes of the failures. Furthermore, the investigation revealed 22 samples requiring re-testing due to OOS results between April 1, 2025, and July 25, 2025, with no corresponding PNCRs documented.B. Your firm’s procedure for Microbiological Testing on(b)(4)water samples, WI 80.002, Rev. 5 establishes an action level of(b)(4)colonies ((b)(4)CFU/mL) and a limit of(b)(4)colonies (equivalent to(b)(4)CFU/mL) and requires nonconformance report initiation when the action levels are exceeded. For example:i. On 6/18/25, microbiological test showed 6 CFU/0.1mL (exceeding the 5 CFU action level) for Diasol acid concentrate batch #3153 (Lot #PHV06191). However, the batch was produced before microbiological results were obtained and before the(b)(4)system disinfection. There was no Product Nonconformity Report initiated to determine the need to investigate the cause of the failure.ii. On 4/28/25, microbiological test showed that action level of(b)(4)CFU/0.1mL was exceeded where the original test results were not documented. The sample was inappropriately re-tested multiple times using frozen/thawed samples on 04/28/2025 and 05/02/2025. The three batches ((b)(4)- Lot(b)(4),(b)(4)- Lot(b)(4), and(b)(4)– Lot(b)(4)) were manufactured on(b)(4)and(b)(4)before obtaining the action level test results and before the(b)(4)system disinfection. There was no Product Nonconformity Report initiated to determine the need to investigate the cause of the failure.C. The firm’s procedure for(b)(4)testing is done by testing each completed batch for endotoxins using the(b)(4)test(b)(4)and(b)(4)water is tested for endotoxins(b)(4)a week. Your firm did not document invalid test results appropriately obtained on 07/10/2025 with(b)(4), package(b)(4)(Exp. Date 08/30/2027), to determine whether investigation of the invalid result was necessary. The same lot of the unevaluated(b)(4)that led to invalid results has been used for(b)(4)product batches and(b)(4)water samples.D. Nonconformance report investigations, disposition, and corrective actions were inadequate for the following nonconformity product reports:i. Product Nonconformity Report #105 was initiated on 6/20/24 for Acetic Acid Glacial (Lot(b)(4)) contaminated with bleach affecting multiple batches of the dialysate acid concentrates. The investigation failed to document how bleach contamination occurred. Your firm received(b)(4)totes but only investigated(b)(4)tote and(b)(4)additional batches were manufactured using remaining(b)(4)totes without verifying they were contamination-free. The preventative actions lacked implementation details for improved raw material controls.ii. Product Nonconformity Report #99 was initiated on 2/12/24 for calcium concentration 8% below acceptable range for Batch(b)(4). The investigation was incomplete such that it failed to address concurrent low glucose and sodium chloride concentrations identified in the same laboratory reports. There was inadequate root cause analysis for multiple component failures.iii. Product Nonconformity Report #102 was initiated on 6/30/25 for low calcium test results for Batch(b)(4)(Lot(b)(4)). The report identified a procedural issue with drum(b)(4)when adding(b)(4)chemicals to(b)(4)drums. You found that(b)(4)with multiple raw materials at once causes displacement and affects test results. Your firm failed to update the associated procedure ((b)(4), WI 70.008, Rev. 1) to prevent recurrence, and inadequate corrective action was implemented.iv. Product Nonconformity Report #104 was initiated on 7/3/25 for Batches (#3170 – Lot #PHV07031, #3168 – Lot #PHV07021, and #3166 – Lot #PHV07011) missing dextrose test results. There is insufficient evidence to support investigation conclusion that contract laboratory equipment was out of service. PNR#104 indicated that the contract lab did not test the samples because the equipment was out of service. The investigators confirmed this claim, but your firm provided incorrect information. Later, your firm admitted you did not reach out to the contract laboratory to find out why the dextrose testing was not performed for the three batches. Your firm released batches without required glucose testing based on unsupported patient safety claims. The investigation lacked risk analysis to justify release without complete testing data.The adequacy of your response cannot be determined at this time. Regarding observation 6A, your firm’s immediate actions are to address the proper handling of OOS test results for the batches by initiating PNCRs or investigate root causes of failures during final acceptance testing. You stated your NCR procedures will be updated, along with managing of DHR documentation, and OOS handling protocols will be implemented. Despite your firm’s historical promises of conducting retrospective PNCRs, there is no evidence of completion, and no corrective actions have been initiated for batches(b)(4)and(b)(4), which also had OOS results requiring documentation and root cause assessment.Regarding observation 6B, your firm indicated that a positive microbial result was attributed to cross-contamination by a new QC employee whose sleeve touched the sample during testing. The(b)(4)water system was disinfected on 6/18, and the water used for batch #3153 reportedly passed quality acceptance after disinfection. Your firm claims no production occurred between 6/16-6/19, however batch #3153 was produced on 6/19 using water from the(b)(4)water system that had not been properly disinfected. Your CAPA plan is to establish deviation documentations, conduct retrospective reviews of batches, perform microbial re-testing of retained(b)(4)water samples, and update procedures to include excursion handling and sample integrity. Your firm claimed that results were "false positive" due to employee error without providing adequate scientific justification. However, there is a contradiction in the timeline: your firm stated no production occurred between 6/16-6/19, yet batch #3153 was produced on 6/19 using water from the compromised system. Your response is inadequate.Regarding observation 6C, your firm investigated with(b)(4)and determined excessive heat caused the test failures of the(b)(4)kit.(b)(4)recommended storing(b)(4)test kits at(b)(4)in refrigerated conditions. Two boxes of compromised test kits were destroyed after producing nonconforming results. You stated that you retested samples using test kits that passed acceptability criteria. Your firm’s CAPA plan is to have(b)(4)test kits stored in refrigerated conditions, review procedure to include flowchart for handling invalid(b)(4)results, conduct mandatory deviation entry, and sample quarantine procedures. Your firm claims only 2 boxes were affected but the FDA findings indicate 40 batches, and 20 samples may be impacted. We have taken into consideration that you evaluated all the impacted products when you initiated your voluntary recall. The adequacy of this response cannot be determined at this time. We will review your response updates along with your procedures and CAPA to ensure the storage and evaluation of materials outside of proper storage conditions are properly addressed.Regarding observation 6D, the following PNCR’s were reviewed and corrective actions implemented for: 1) PNCR #105: corrective action was taken to perform analytical testing of retained samples, implementation of chlorine strip testing for acetic acid totes, staff training on contamination protocols, revised PNCR templates, and enhanced supplier qualification processes. However, there is still no clear explanation of detection method for bleach contamination, 2) PNCR #99: corrective action is to have the batch rework to restore specifications, expanded PNCR documentation, QA staff training on deviation protocols, and revise SOPs requiring investigation of all OOS parameters. Your firm acknowledged that glucose and sodium issues were not investigated but provides no evidence this has been corrected, 3) PNCR #102: corrective action is taken to update your work instructions (WI 70.009 and 70.008) with clear restrictions against simultaneous(b)(4)of multiple chemicals, implementation of step-by-step(b)(4)procedures, and provide personnel training, and 4) PNCR #104: your corrective action is to conduct retrospective risk assessment, enhanced verification protocols, revise SOPs requiring all critical test results before release, and implementation of batch disposition checklists. However, your firm justifies releasing batches without required testing based on "emergency" needs of your customers. The adequacy of your response for observation 6D cannot be determined at this time as corrective actions are in progress.Our overall concerns with this observation and the corrective actions taken is your summary reveals systemic issues including delayed reporting, incomplete investigations, inadequate documentation, and patterns of releasing products without full quality data verification. Please ensure these corrective actions have been adequately verified and implemented and provide supporting documentation when they are available.7. Failure to adequately establish procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR § 820.198(a). Specifically,Your firm has not adequately followed your complaint handling procedure, Complaint File, SOP 198.001, Rev. 2, as you failed to document and determine the need to investigate “order replacements” related to complaints about product, packaging, and labeling issues. For example, the following complaints were not properly investigated:A. Reviewed a complaint on 5/20/24 about product G100225-10DEX100 (Lot(b)(4)) causing unstable conductivity in dialysis machines preventing patient treatment.B. Eight complaints between March 2024 and July 2025 were reviewed for damaged cases of gallons and bags.C. One complaint in June 2024 was reviewed about missing gallon labels on Citric Acid 50% products.D. Two complaints in 2025 involving cracked drums that caused product leakage.E. One March 2024 return logged for damaged case and bag.Your firm also failed to evaluate any of these complaints to determine whether they constituted medical device reportable events.The adequacy of your response cannot be determined at this time. Your firm proposed corrective and preventative actions to address “product replacements” related to complaints about product, packaging, and labeling issues that are documented into your complaint tracking system. However, your firm continues to classify “product replacements” due to damage, labeling, or performance issues as “requests” rather than complaints requiring formal documentation and evaluation. While your firm updated your SOP to include replacements as complaints, you simultaneously maintain that transit damage replacements are not complaints. Your firm states that none of the complaints are reportable without demonstrating proper application of MDR evaluation criteria. Despite mentioning implementation of an MDR screening process, your firm has not demonstrated understanding of proper MDR criteria for assessing individual complaints.Please refer to 21 CFR Part 820.198(a)(3) for further guidance to evaluate whether the complaint represents an event which is required to be reported to FDA under Part 803, Medical Device Reporting.8. Failure to adequately establish procedures for corrective and preventive action, as required by 21 CFR § 820.100(a). Specifically,Your firm failed to adequately implement your Corrective and Preventive Action (CAPA) procedure, SOP 100.001, Rev. 1 with multiple systemic issues identified across four specific CAPAs. For example,A. CAPA #24 was initiated on 2/16/24 and closed on 8/8/24 to address Diasol Acid Concentrate mix ratio issue which was not adequately investigated and failed to expand scope when a second complaint occurred on 5/9/24 involving(b)(4)gallons of concentrate with unstable conductivity readings. Your firm failed to adequately investigate why batch exceeded production yield (NPR No. 98) before lot release. Your firm did not document additional testing, product removal, and rework activities performed on returned product.B. CAPA #25 was initiated on 2/16/24 and closed on 8/8/24 to address nonconformances associated with labeling controls. The CAPA was ineffective as new mislabeling complaint occurred on 6/11/24 during the effectiveness verification phase. The original CAPA addressed mislabeled Diasol acid concentrate (Complaint #03, 7/27/22) but was closed as effective on 8/8/24 despite ongoing issues. The new complaint involved unlabeled Citric Acid 50%-gallon containers.C. CAPA #26 was initiated in May 2024 and appended CAPA 26A initiated on 12/10/24 to address facility and equipment deterioration identified in internal audit for plant equipment cleaning and maintenance, salt deposits that damage equipment and floors, and(b)(4)water that damages pressure worker motor. No corrective actions have been completed or documented.D. CAPA #27 was initiated on 4/10/24 to correct a previous 483 observation for inadequate response with unclear scope, insufficient root cause analysis, and inadequate corrective actions. The CAPA has been open since 4/10/24 and repeat deficiencies were found during the current inspection.The adequacy of your response cannot be determined at this time. Your firm acknowledged the CAPA deficiencies and committed to taking corrective actions to ensure Part 820.100 is followed. However, CAPA #24 has no evidence the expanded investigation was completed, and no documentation was provided regarding evaluation of the additional(b)(4)gallons that failed conductivity. There is no assurance that a link has been established to NCR #98 for excess yield issues. CAPA #25 was addressed with promised corrective actions and CAPA #30 was generated for additional actions, but neither provide evidence of addressing the root causes. Your firm has not demonstrated that cross-product labeling risks are controlled, and implementation verification is delayed until March 2026. CAPA #26 is a repeat observation spanning 7 years (2018-2025) with no actual corrections and response consists only of additional promises without actual progress. Finally, corrections to CAPA #27 and its root cause analysis is inadequate and there is no evidence that repeat deficiencies have been addressed.9. Failure to establish design history file, as required by 21 CFR § 820.30(j). Specifically,Your firm did not adequately implement your Design Control procedure, SOP 30.001, Rev.1, for maintaining adequate design documentation. For example,A. Lack of Design History File (DHF) for Citric Acid (50% and 20% concentrations) used for cleaning, decalcification, and disinfecting hemodialysis machines, despite manufacturing and distributing(b)(4)batches since 2022.B. Inadequate Design History Files (DHFs) for Dryasol and Citrisol such that it references design inputs for "Diasol acid concentrate," but no DHF exists for this referenced device. The electrolyte concentration specifications claim compliance with(b)(4)standards, but the actual acceptability ranges for Potassium and Calcium do not meet the standard requirements. Also, the DHFs fail to include or reference the location of required design verification and validation studies for these Class 2 medical devices.The adequacy of your response cannot be determined at this time. Your firm acknowledges poor implementation due to considering legacy formulations “low risk” and inadequate training on applying design controls to accessory products. Your firm stated you suspended sales as of September 1, 2025, and are determining if a 510(k) is needed, but this doesn't address years of non-compliance or demonstrate proper regulatory understanding. Your firm stated that your DHFs reference non-existent Diasol acid concentrate design inputs and the Electrolyte specifications for potassium and calcium do not meet(b)(4)standards. There is no design verification and validation documentation provided. Your firm plans to create the missing DHFs and update specifications but claims Diasol was marketed in 1985 prior to design file implementation, which does not exempt it from current requirements.10. Failure to adequately establish procedures for design change, as required by 21 CFR § 820.30(i). Specifically,Your firm did not implement your procedure, Design Control, SOP 30.001, Rev.1, by failing to adequately document, evaluate, and validate design change made to the Diasol Acid Concentrate device before implementation. For example:Your firm used Calcium Chloride Anhydrous instead of the required USP grade Calcium Chloride Dihydrate in(b)(4)manufacturing batches (August 19-21, 2024), totaling(b)(4)gallons of products. This substitution caused elevated calcium concentrations in batches(b)(4)(Lot(b)(4)),(b)(4)(Lot(b)(4)), and(b)(4)(Lot(b)(4)), requiring a Product Nonconformity Report (#100) on 8/22/2024 and subsequent rework to correct the calcium levels. Your firm failed to conduct required risk assessments regarding patient safety impacts and did not perform validation studies to evaluate potential effects on users, product stability, or long-term device performance.The adequacy of your response cannot be determined at this time. Your firm’s corrective action includes issuance of PNR#100 and rework of all(b)(4)affected batches. You quarantined and removed the remaining substituted raw material from inventory. You created retrospective design change documentation and updated your SOP design control procedure to clarify that raw material substitutions constitute design changes. You stated that you haven’t conducted training for QA, R&D, and procurement teams, and implemented mandatory design change checklist and(b)(4)compliance audits. You plan to conduct formal risk assessments for all design changes, including raw material substitutions, and mandate validation or verification studies prior to implementing any design changes. However, your firm has not provided a comprehensive risk assessment for this incident to evaluate potential ramifications of ingredient substitution. There is no demonstration that proper validation studies were conducted to establish equivalency of the substituted material.11. Failure to adequately establish procedures for design verification, as required by 21 CFR § 820.30(f). Specifically,Your firm has not adequately implemented your procedure for Design Controls, SOP 30.001, Rev. 1, section 4.6 Design Verification, regarding inadequate design verification for stability studies supporting product shelf-life claims. For example:A. The 3-year shelf-life stability study of your Diasol and Citrisol acid concentrates(Stability Study Protocol and Stability Study Report, both numbered #110.001, signed 05/09/2019)lacks any supporting laboratory data and fails to demonstrate that tested products used the same container closure system as finished products. There is no scientific rationale provided for sample selection, including testing a Diasol formulation with different magnesium concentration ((b)(4)mEq/L vs. current(b)(4)mEq/L) and selecting(b)(4)lot of(b)(4)Citrisol acid concentrations. There is missing evidence that required pH and Conductivity testing was performed at all specified time points per the stability protocol requirements inWI 80.004 In-process and Final Batch Testing.B. No stability study exists to support the assigned 3-year shelf-life for the Dry Citrisol Acid Concentrate. The product’s expiration date exceeded the expiration date of at least one packaged raw material powder used in two different lots ((b)(4)and(b)(4)), which are set for(b)(4), and(b)(4). Meanwhile, the citric acid powder (Lot(b)(4)) in both products will expire on(b)(4).Your response is inadequate. Your firm stated you have a long manufacturing history, producing concentrates since 1998 (with predecessor(b)(4)manufacturing since 1985). However, your stability study performed in 2019 used an outdated formulation ((b)(4)mEq Mg) while current products contain(b)(4)mEq Mg. Your firm claims the(b)(4)mEq magnesium difference will not impact stability of the acid concentrate solution. The initial batch testing included proper pH and conductivity documentation, and subsequent tests have handwritten pH and conductivity records. You said you will perform verification on all lab samples to ensure correct dilution. However, your firm failed to provide missing laboratory data and there is no documented justification showing the older formulation is representative of current products. There is no demonstration that the magnesium difference does not affect stability conclusions and despite mentioning handwritten records and verification procedures, actual testing data remains missing. Your firm failed to demonstrate compliance with your protocol or address systematic documentation gaps. Additionally, your responses indicated that additional time is required to respond to this part of the observation.12. Failure to adequately establish requirements that must be met by contractors and consultants, as required by 21 CFR § 820.50(a). Specifically,Your firm failed to adequately implement your supplier evaluation procedure, SOP 50.001, Rev. 2 in two main areas:A. Your firm lacks documented evaluation of your contract laboratory that performs chemical analysis of dialysis acid concentrate products. No documented evidence exists that the laboratory uses validated analytical test methods per(b)(4)standards. The laboratory's(b)(4)method is inadequately justified for testing potassium, magnesium, glucose, and calcium levels, as the standard only indicates(b)(4)for sodium analysis. Despite four information requests, your contract laboratory failed to provide complete details about their analyzers and test methodologies, leaving your firm unaware of actual testing procedures.B. Your firm lacks documented evaluation demonstrating that your quality audit consultant is competent to conduct(b)(4)audits.The adequacy of your response cannot be determined at this time. The response requested additional time to respond to this item and mentions you are planning to update your supplier qualifications. Review of these responses found no documented evaluation exists for the contract laboratory performing chemical analysis. No evidence was provided demonstrating the laboratory uses validated analytical test methods per(b)(4)standards and the laboratory's(b)(4)method is only validated for sodium analysis, not for potassium, magnesium, glucose, and calcium as required. Your firm has not provided evidence that you have taken immediate steps to obtain proper documentation or verify the analytical methods from your contract laboratory.Regarding observation 12B, your firm stated that you contracted(b)(4)for your last two internal audits. Your firm plans to hire a certified auditor for 2025 and establish qualification criteria based on experience and certification. A CAPA table was provided, but no corrective actions have been implemented yet—all items are scheduled for future completion. Your firm’s planned corrective actions include conducting formal competency assessments, reviewing qualifications and certifications, creating consultant evaluation forms, updating QMS procedures, and staff training. Your firm has not provided evidence that you have taken any immediate action to address the ongoing use of potentially unqualified suppliers and consultants. The adequacy of this response cannot be determined.13. Failure to perform risk analysis, as required by 21 CFR § 820.30(g). For example,A. Your firm does not have a documented risk analysis for your Diasol liquid acid concentrate.B. The existing risk analysis for your Dryasol acid concentrate fails to evaluate potential harms to patients and users for hazards already identified in your firm’s risk analysis document (DHF 30.003, rev. 1). The analysis does not include risk estimations for known and foreseeable hazards associated with dialysate concentrates, including electrolyte imbalance, lack of dextrose, pyrogen reactions, microbial infections, particulate emboli, and toxicity from chemical contaminants.The adequacy of your response cannot be determined at this time. Your firm’s stated that you initiated a risk analysis for your Diasol liquid acid concentrate by following(b)(4)standard. Your preventative actions include risk analysis for all products and staff training, and CAPA #2025-04-DLC is scheduled to be completed by 12/08/25. A review of your firm’s corrections observed that products continue to be manufactured and distributed without documented risk analysis. You should ensure critical elements such as detailed hazard identification, quantitative risk estimation (severity x probability), specific risk control measures, and residual risk evaluation. The 4+ month timeline to correct the observation appears to be excessive.Regarding observation 13B, your firm updated your risk analysis procedure to include patient risk assessment. Immediate action is to initiate internal review of DHF 30.003, Rev. 3 by a cross-functional team to include all known and foreseeable hazards and incorporate clinical harms and severity ratings. Your preventative action is to update risk management SOPs to require clinical review and train design and regulatory affairs teams on(b)(4)and FDA guidance. However, your firm submitted DHF 30.002 for Citrisol instead of the required Dryasol analysis. The adequacy of this response cannot be determined.Medical Device Reporting Violation(s)Our inspection also revealed that your firm’s dialysate concentrates are misbranded under section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that your firm failed or refused to furnish material or information respecting the device that is required by or under section 519 of the Act, 21 U.S.C. § 360i. 21 CFR Part 803 - Medical Device Reporting was promulgated under section 519 of the Act, among other provisions. Significant violations include, but are not limited to, the following:1. Failure to report to us the information required by § 803.52 in accordance with the requirements of § 803.12(a), no later than 30 calendar days after the day that your firm received or otherwise became aware of information, from any source, that reasonably suggests that a device that it markets has malfunctioned and this device or a similar device that your firm markets would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur, as required by 21 CFR 803.50(a)(2).For example, the information included in your firm’s internal email communication dated May 20, 2024, reasonably suggests that your firm’s Diasol liquid acid concentrate malfunctioned during use. Specifically, the device caused unstable conductivity in the dialysis machine, preventing the dialysis treatment from being performed. As a result, the device failed to meet its performance specifications or otherwise perform as intended under 21 CFR 803.3(k). This device, classified as a hemodialysis system and accessories under 21 CFR 876.5820 (product code KPO), is considered life-supporting or life-sustaining. A malfunction is reportable if it involves a device that is considered to be life-supporting or life-sustaining and thus is essential to maintaining human life, as is the case here, or if it results in the failure of the device to perform its essential function—here, dialysis—thereby compromising the device’s therapeutic effectiveness, which could cause or contribute to a death or serious injury. See Medical Devices; Medical Device User Facility and Manufacturer Reporting, Certification and Registration, 60 Fed. Reg. 63578, 63585 (Dec. 11, 1995), Comment 12, for more information. Accordingly, because this device malfunctioned and the device or a similar device you market would be likely to cause or contribute to a death or serious injury if the malfunction were to recur, the adverse event represents a reportable malfunction under 21 CFR 803.3. During the inspection, your firm acknowledged that no MDR had been submitted for this event.The adequacy of your firm’s response dated September 8, 2025, cannot be determined at this time. In its response, your firm states that it plans to revise its MDR procedure, conduct staff training, and perform a retrospective review to submit MDRs for each identified MDR Reportable complaint. FDA has not yet received an electronic version of Form 3500A for the above reference event. In addition, no supporting documentation of corrective actions was provided, as these remain in progress.Your firm’s responses dated October 7, 2025, and November 10, 2025, did not provide evidence or documentation to address the noted violation.In addition, the inspection revealed that your firm failed to adequately develop, maintain, and implement written MDR procedures as required by 21 CFR 803.17. For example, during the inspection, your firm presented its procedural documents titled “Complaint File”, SOP 198.001, Rev. 2, dated 04/25/2024 and “Medical Device Reporting (MDR) Procedure”, SOP 198.002, Rev. 2, dated 04/25/2024. After collectively reviewing them as your firm’s MDR procedure, the following deficiencies were noted:a) The procedure does not establish internal systems that provide for timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements, as required by 21 CFR 803.17(a)(1). For example, the procedure does not include adequate definitions of what constitutes a reportable event under 21 CFR Part 803. The fact that the procedure does not include definitions from 21 CFR 803.3 for the terms “become aware”, “caused or contributed”, and “malfunction”, and the definition found in 21 CFR 803.20(c)(1) for the term “reasonably suggests”, may lead your firm to make an incorrect reportability decision when evaluating a complaint that may meet the criteria for reporting under 21 CFR 803.50(a).b) The procedure does not establish internal systems that provide for timely transmission of complete medical device reports, as required by 21 CFR 803.17(a)(3). Specifically, your procedure does not include:i. Instructions for how to obtain and submit information that corresponds generally to the format of Form FDA 3500A.ii. Instructions for how your firm will comply with the 21 CFR 803.12(a) requirement to submit reports to FDA in an electronic format that the FDA can process, review, and archive.iii. How your firm will ensure that all information required in 21 CFR Part 803, subpart E, that is reasonably known to you is submitted for each event. Specifically, which types of information corresponding generally to the format of Form FDA 3500A will need to be submitted, to include the information in your possession at the time you filed your initial report and if you later obtain any required information that was not available at the time you filed your initial report.In addition, based on FDA’s records, as of October 8, 2025, your firm has not completed its load test and guidance compliance submission for electronic Medical Device Reporting (eMDR). We recommend your firm follow the instructions located at https://www.fda.gov/medical-devices/emdr-electronic-medical-device-reporting/how-enroll-emdr-program under “Low Volume Enrollment Process” to obtain its WebTrader production account.The adequacy of your firm’s response dated September 8, 2025, cannot be determined at this time. In its response, your firm stated that it plans to update its MDR procedure by November 8, 2025, conduct staff training, and establish an electronic submission account. However, no supporting evidence was provided, as these corrective actions are still ongoing.We reviewed your firm’s response dated October 7, 2025, and concluded that it is not adequate. Your response states that corrective actions are still in progress and included a copy of its revised MDR procedure titled “Medical Device Reporting (MDR) Procedure”, SOP 198.002, Rev. 2, dated 09/09/2025. Upon review of the revision, the following deficiencies were noted:The revision does not include adequate definitions of what constitutes a reportable event under 21 CFR Part 803. Specifically, the revision still omits the definition of “malfunction” in 21 CFR 803.3, and “reasonably suggests” in 21 CFR 803.20(c)(1). The absence of these definitions may lead your firm to make an incorrect reportability decision when evaluating a complaint that may meet the criteria for reporting under 21 CFR 803.50(a).The revision does not include the requirement for submitting supplemental or follow up reports within 30 calendar days of the day that you receive information required under 21 CFR Part 803 that you did not provide because it was not known or was not available when you submitted the initial report, as required under 21 CFR 803.56.In addition, your firm has not yet completed its load test and guidance compliance submission for eMDR. We recommend that your firm follow the instructions provided above to obtain a WebTrader production account for electronic submissions.Your firm’s response dated November 10, 2025, did not provide evidence or documentation to address the noted violation.Unique Device Identifier (UDI) and GUDID Violation(s)Misbranding under Section 502(c) for Failure to Have Compliant LabelingThe inspection also revealed that your devices are misbranded within the meaning of section 502(c) of the Act, 21 U.S.C. § 352(c), because a word, statement, or other information required by or under authority of the Act to appear on the label or labeling of the devices was not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use. In particular, 21 CFR 801.20(a) – which was promulgated under authority of section 519 of the Act, among other provisions – requires, with exceptions not relevant here, that the label and device package of every medical device bear a unique device identifier (UDI) that meets the requirements of 21 CFR Part 801, subpart B, and 21 CFR Part 830. The labels of Citrisol Powder 45125-10, CitriSol 100225-10, Diasol 100225-10, Citric Acid 50%, Diasol 10000-25, and Dryasol 45225-10 devices do not bear such a UDI.Specifically, the labels for Citrisol Powder 45125-10, CitriSol 100225-10, Diasol 100225-10, Citric Acid 50%, Diasol 10000-25, and Dryasol 45225-10 devices do not include a device identifier within the meaning of 21 CFR 801.3 or 830.3, and there is no UDI presented in easily readable plain-text on the label of the device (see 21 CFR 801.40(a)(1)), and there is no UDI presented in machine-readable form that uses Automatic Identification and Data Capture (AIDC) technology on the label of the device (see 21 CFR 801.40(a)(2)).Misbranding under Section 502(t)(2) for Failure to Submit Required InformationIn addition, Citrisol Powder 45125-10, Citric Acid 50%, and Dryasol 45225-10 devices are misbranded within the meaning of section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that there was a failure or refusal to furnish any material or information required by or under section 519 of the Act, 21 U.S.C. § 360i, respecting these devices. In particular, 21 CFR 830.300(a) and 830.320(b) – both of which were promulgated under section 519 of the Act, among other provisions – require that the labeler of a device submit electronically to FDA’s Global Unique Device Identification Database (GUDID) the information required by 21 CFR Part 830, subpart E, for each version or model required to bear a UDI. FDA has determined that your firm causes a label to be applied to a device with the intent that the device will be commercially distributed without any subsequent replacement or modification of the label. Our inspection revealed that your firm designs the finished product label for your Citrisol Powder 45125-10, Citric Acid 50%, and Dryasol 45225-10 devices and final product labeling reflects your firm’s name, and address. Diasol, Inc is therefore a “labeler” within the meaning of 21 CFR 830.3 and has not submitted to GUDID any information required by 21 CFR Part 830, subpart E, respecting these devices.Our office requests that Diasol, Inc. immediately cease any activities that result in the misbranding or adulteration of your devices, such as the commercial distribution of your devices for the uses described above.A follow up inspection will be required to assure that corrections and/or corrective actions are adequate.Your firm should take prompt action to address any violations identified in this letter. Failure to adequately address this matter may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties. Other federal agencies may take your compliance with the FD&C Act and its implementing regulations into account when considering the award of federal contracts. Additionally, should FDA determine that you have Quality System regulation violations that are reasonably related to premarket approval applications for Class III devices, such devices will not be approved until the violations have been addressed. Should FDA determine that your devices or facilities do not meet the requirements of the Act, requests for Certificates to Foreign Governments (CFG) may not be granted.We are requesting that you submit to this office on the schedule below, certification by an outside expert consultant that he/she has conducted an audit of your firm’s manufacturing and quality assurance systems relative to the requirements of 21 CFR Part 820. You should also submit a copy of the consultant's report, and certification by your establishment's Chief Executive Officer (if other than yourself) that he or she has reviewed the consultant's report and that your firm has initiated or completed all corrections called for in the report. The initial certifications of audit and corrections and subsequent certifications of updated audits and corrections (if required) should be submitted to this office by the following dates:Initial certifications by consultant and establishment – July 31, 2026.Subsequent certifications – September 1, 2027, and September 1, 2028.Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps you have taken to address the noted violations, as well as an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective action (which should address systemic problems) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective action cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm’s response should be comprehensive and address any violations included in this Warning Letter. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration as part of your response.Your firm’s response should be sent via email to Establishment Assessment Team 3 Acting Assistant Director, Jeffrey Wooley, at CDRHEnforcement@fda.hhs.gov . Please include in the subject line, “CMS Case 719460” when replying. If you have any questions about the contents of this letter, please contact: Compliance Officer, Charles J. Chacko, via email at charles.chacko@fda.hhs.govFinally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility or associated with your firm’s devices. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of any violations and take prompt actions to address any violations and to bring the products into compliance.Sincerely,/S/Barbara C. MarsdenActing DirectorOffice of Regulatory ProgramsOffice of Product Evaluation and QualityCenter for Devices and Radiological Health

根据《中华人民共和国药品管理法》和国家市场监督管理总局《药品生产监督管理办法》的有关规定，经按程序进行现场检查、综合评定和审核，准予核发安徽健诚药业有限公司、欧普康视科技股份有限公司、安徽凤凰中药饮片有限公司、安徽保信堂中药科技有限公司、安徽千佰意中药科技有限公司、安徽梦生药业有限公司、大仁堂（安徽）药业有限公司、安徽新正药业有限公司、宝瀛（芜湖）电子特种气体有限责任公司《药品生产许可证》（具体信息见附件）。特此公告。                                         安徽省药品监督管理局                                         2026年3月3日许可证编号企业名称统一社会信用代码住所（经营场所）法定代表人企业负责人生产负责人质量负责人质量受权人生产地址及生产范围分类码发证日期有效期至皖20250657安徽健诚药业有限公司91341600MAEGQXAE7Y安徽省亳州市高新技术产业开发区酒城大道588号孙浩宸孙浩宸陈利青王帅帅王帅帅安徽省亳州市高新技术产业开发区酒城大道588号：中药饮片（含毒性饮片）***Ay2025122620301225皖20250658欧普康视科技股份有限公司91340100723323559X合肥市高新区望江西路4899号陶悦群王殿阔陈平郝展飞郝展飞合肥市高新区望江西路4899号：滴眼剂（注：未进行药品GMP符合性检查，仅限注册申报使用）***Ah2025122620301225皖20260659安徽凤凰中药饮片有限公司91341600MA2WJF8C36安徽省亳州市谯城区大杨镇罗湖路1号李坤鹏李国华张永强李贝蓓李贝蓓安徽省亳州市谯城区大杨镇罗湖路1号：中药饮片***Ay2026010420310103皖20260660安徽保信堂中药科技有限公司91341600MAEL7T5C9P安徽省亳州市高新技术产业开发区汤王大道与茴香路交叉口向西150米路北李康李康王洪亮王九玉王九玉安徽省亳州市高新技术产业开发区汤王大道与茴香路交叉口向西150米路北：中药饮片（直接口服饮片）***Ay2026011320310112皖20260661安徽千佰意中药科技有限公司91341600MAEB556E6P安徽省亳州市高新技术产业开发区亳州芜湖现代产业园区月季路北侧、扶摇路东侧5号厂房张瑞敏张瑞敏孟磊刘影刘影安徽省亳州市高新技术产业开发区亳州芜湖现代产业园区月季路北侧、扶摇路东侧5号厂房和1号厂房二楼三楼：中药饮片、中药饮片（毒性饮片）***Ay2026011920310118皖20260662安徽梦生药业有限公司91341600MAEBHT7680安徽省亳州市高新技术产业开发区酒城大道298号1号楼王佳王佳田彬张静张静安徽省亳州市高新技术产业开发区酒城大道298号1号楼、3号楼、4号楼：中药饮片，中药饮片（毒性饮片）***Ay2026012320310122皖20260663大仁堂（安徽）药业有限公司91341602MADDK8484X安徽省亳州市谯城区经开区紫苑路1391号张敬德张冰孙振国刘颖刘颖安徽省亳州市谯城区经开区紫苑路1391号：中药饮片，中药饮片（毒性饮片）***Ay2026020520310204皖20260664安徽新正药业有限公司91341500MA2T4Q6M8X安徽省六安经济技术开发区元亨路466号刘国卫刘国卫张应许孙佳慧孙佳慧安徽省六安经济技术开发区元亨路466号：中药饮片，中药饮片（毒性饮片）***Ay2026020520310204皖20260665宝瀛（芜湖）电子特种气体有限责任公司91340200MA8PAUUF48安徽省芜湖市经技术开发区保顺路66号席航吴彦东朱烨任杰任杰安徽省芜湖市经技术开发区保顺路66号：氧（液态）（注：未进行药品GMP符合性检查，仅限注册申报使用）***Aq2026021020310209

飞利浦（中国）投资有限公司报告，Philips已获悉一个潜在的安全问题，如果用户在清洁或消毒 MobileDiagnost wDR 系统时使用了过量的液体，或将液体直接喷洒在系统上，则液体有可能进入把手按钮的边缘，从而导致金属腐蚀或覆盖层连接器发生短路。 (召回文件内部编号：Recall-2026-04) 飞利浦（中国）投资有限公司对其生产的移动式摄影X射线机（注册证号：国械注进20182060009）主动召回。召回级别为三级。涉及产品的型号、规格及批次等详细信息见《医疗器械召回事件报告表》。2026年03月03日

Delivery Method:VIA UPSReference #:320-25-74Product:DrugsRecipient:Mr. Luis E. EcheverriaPresidentEvi Labs LLC9110 NW 106th StreetMedley,FL33178United StatesIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter320-25-74May 14, 2025Dear Mr. Echeverria:The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Evi Labs LLC, FEI 3014581785, at 9110 NW 106th Street, Medley, Florida, from January 9 to 15, 2025.This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 211).Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).We reviewed your January 30, 2025 response to our Form FDA 483 in detail. Your response is inadequate because you failed to provide supportive documentation for evaluation or adequate evidence of corrective actions taken to bring your operations into compliance with CGMP.During our inspection, our investigators observed specific violations including, but not limited to, the following.1. Your firm failed to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release (21 CFR 211.165(a)).You manufacture over-the-counter (OTC) drug products, including topical drug products containing the active ingredient aluminum chlorohydrate. You released batches of drug products for distribution without conducting adequate strength and identity testing.In your response, you provide test results from retained samples of Zermat brand antiperspirant deodorants. However, your response is inadequate because some results did not meet your established specifications. For example, test results for lot 291023 of Zermat Kiwi Perfumado, topical roll-on antiperspirant, showed a concentration of aluminum chlorohydrate that far exceeded the product labeled amount. Furthermore, under the OTC antiperspirant monograph (M019), aluminum chlorohydrate is permitted in concentrations up to 25%. However, the potency for lot 291023 was found to be above 25% for aluminum chlorohydrate. A topical roll-on antiperspirant drug product with a concentration above 25% for aluminum chlorohydrate is not permitted under M019. You did not include an investigation into these failing results nor provide an action plan to address violative drug product in interstate commerce within expiry.Testing is essential to ensure that the drug products you manufacture conform to all pre-determined quality attributes appropriate for their intended use and to ensure active ingredients meet specifications based on label claim. Because you lacked adequate testing of each batch of your drug products, you do not know whether they conform to all appropriate finished product specifications and are suitable for release to consumers.In response to this letter, provide:A list of chemical specifications, including test methods, used to analyze each lot of your drug products before a lot disposition decision.An action plan and timelines for conducting full chemical testing of retain samples to determine the quality of all batches of drug product distributed to the United States that are within expiry as of the date of this letter.A summary of all results obtained from testing retain samples from each batch. If such testing reveals substandard quality drug products, take rapid corrective actions, such as notifying customers and product recalls.A comprehensive independent assessment of your laboratory practices, procedures, methods, equipment, documentation, and analyst competencies. Based on this review, provide a detailed plan to remediate and evaluate the effectiveness of your laboratory system.2. Your firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity (21 CFR 211.160(b)).Your firm failed to establish adequate microbiological specifications for your OTC drug products including(b)(4)oral suspension and topical antiperspirant deodorants. For example, your microbiological specifications were set at(b)(4)times greater than the United States Pharmacopoeia (USP) guidance for each of the dosage forms. This resulted in your approval and release of antiperspirant drug products which had exceeded the microbiological quality for your products intended use.In your response, you state that you have implemented microbiological limits specifications that align with USP guidance and commit to obtaining speciation for any further recovered micro-organisms. However, you have not committed to perform retrospective testing and assessing impact on previously distributed product that may not have met your newly established specifications.Adequate microbial specifications and testing methods to detect objectionable microorganisms in the presence of each drug product must be established to ensure that they are suitable for use by consumers.In response to this letter, provide:A list of microbial specifications, including test methods, used to analyze each lot of your drug products before a lot disposition decision.An action plan and timelines for conducting microbiological testing of retain samples to determine the quality of all batches of drug product distributed to the United States that are within expiry as of the date of this letter.A summary of all results obtained from testing retain samples from each batch. If such testing reveals substandard quality drug products, take rapid corrective actions, such as notifying customers and product recalls.Clarification on whether you intend to continue production for each of your OTC drug products.3. Your firm failed to establish adequate written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess, and your firm’s quality control unit did not review and approve those procedures, including any changes (21 CFR 211.100(a)).Inadequate Water SystemYour firm uses water as a component to manufacture your OTC drug products, including aqueous drugs labeled for use in(b)(4). You failed to adequately validate your water production process to ensure it was consistently producing water of appropriate quality for its intended use, including the manufacture of oral and topical drug products. Additionally, your(b)(4)water system was not adequately designed or maintained, which could foster the development of biofilms. For example, your water system included a dead leg, was not continuously circulating, and was not subjected to validated sanitization processes. Furthermore, you failed to demonstrate that your water system was adequately monitored to ensure it consistently produced water that met appropriate chemical and microbial attributes.In your response, you commit to hiring a consultant to re-design your water system. However, your response is inadequate because you have not committed to perform routine monitoring and to perform a retrospective impact assessment for products manufactured with water which failed to meet compendial standards and appropriate microbial quality.(b)(4)water must be suitable for its intended use and routinely tested to ensure ongoing conformance with appropriate chemical and microbiological attributes. Routine monitoring of microbial counts and identity of contamination in the system is integral to ensuring oversight of the ongoing state of control and suitability of water for use in pharmaceutical manufacturing operations.Inadequate Process ValidationYou have not validated the processes used to manufacture your OTC drug products.Furthermore, you failed to ensure adequate documentation and control over critical processing steps subject to variation (e.g., blend times, speeds, and temperatures) and proper qualification of equipment including scales used for your weight-based manufacturing processes.In your response, you commit to writing validation procedures and providing critical process parameters. However, your response is inadequate because there is no assurance of completed process validation for each product, and you did not include critical attributes of a blended process dependent on variations in temperature. You also commit to calibrating your scales; however, you failed to provide supporting documentation. In addition, you did not consider a retrospective assessment of potential impact to your product distributed to the United States within expiry.Process validation evaluates the soundness of design and state of control of a process throughout its lifecycle. Each significant stage of a manufacturing process must be designed appropriately and assure the quality of raw material inputs, in-process materials, and finished drugs.Process qualification studies include intensive monitoring and testing throughout each significant process stage to characterize intra-batch variation and evaluates batches to determine whether an initial state of control has been established.Successful process qualification studies are necessary before commercial distribution. Thereafter, ongoing vigilant oversight of process performance and product quality is necessary to ensure you maintain a stable manufacturing operation throughout the product lifecycle. See FDA’s guidance for industry,Process Validation: General Principles and Practices, for general principles and approachesthat the FDA considers appropriate elements of process validation at https://www.fda.gov/media/71021/download.In response to this letter, provide:A comprehensive, independent assessment of your water system design, control, and maintenance.A thorough remediation plan to install and operate a suitable water system. Include a robust ongoing control, maintenance, and monitoring program to ensure the remediated system design consistently produces water adhering to(b)(4)Water,(b)(4)monograph specifications and appropriate microbial limits.A detailed risk assessment addressing the potential effects of the observed water system failures on the quality of all drug product lots currently in U.S. distribution or within expiry. Specify actions that you will take in response to the risk assessment, such as customer notifications and product recalls.A detailed summary of your validation program for ensuring a state of control throughout the product lifecycle, along with associated procedures. Describe your program for process performance qualification (PPQ), and ongoing monitoring of both intra-batch and inter-batch variation to ensure a continuing state of control.A timeline for performing PPQ or each of your marketed drug products.Process performance protocol(s), and written procedures for qualification of equipment and facilities.A detailed program for designing, validating, maintaining, controlling and monitoring each of your manufacturing processes that includes vigilant monitoring of intra-batch and inter-batch variation to ensure an ongoing state of control. Also, include your program for qualification of your equipment and facility.4. Your firm failed to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products and the authority to review production records to assure that no errors have occurred or, if errors have occurred, that they have been fully investigated (21 CFR 211.22(a)).The records and information you provided demonstrate that your quality unit (QU) did not effectively exercise its responsibilities to oversee the quality of your drug manufacturing operations. Specifically, your QU failed to:Ensure the quality of active pharmaceutical ingredients used in(b)(4)oral suspension drug product (21 CFR 211.84).Ensure thorough investigations into unexplained discrepancies or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192).Ensure appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records, or other records (21 CFR 211.68(b)).Ensure establishment of a written testing program designed to assess the stability characteristics of drug products and to use results of stability testing to determine appropriate storage conditions and expiration dates (21 CFR 211.166(a)).Furthermore, your quality unit failed to reject topical drug products for distribution which either failed microbial limits testing or had not been subjected to finished product testing for potency.In your response, you acknowledge that you lack stability data for your(b)(4)oral suspension drug product and committed to placing samples on stability. Your response is inadequate because you did not commit to retrospective testing of retained samples to support product currently in interstate commerce. Additionally, stability data provided for your topical antiperspirant drug products did not reflect your actual operations (e.g., facility, equipment, and manufacturing processes), and your proposed stability protocol did not include stability indicating methods as well as assessment for impurities or microbial quality. Furthermore, you do not commit to reviewing original data for each batch produced prior to product approval and release.Significant findings in this letter demonstrate that your firm does not operate an effective quality system in accordance with CGMP. In addition to the lack of effective management oversight of your production and laboratory operations, we found that your QU was not enabled to exercise proper authority and insufficiently implemented its responsibilities. Executive management should immediately and comprehensively assess your company’s manufacturing operations to ensure that your systems, processes, and products meet CGMP.Your firm’s quality systems are inadequate. See FDA’s guidance documentQuality Systems Approach to Pharmaceutical CGMP Regulationsfor help in implementing quality systems and risk management approaches to meet the requirements of CGMP regulations 21 CFR parts 210 and 211, at https://www.fda.gov/media/71023/download.In response to this letter provide:A comprehensive assessment and remediation plan to ensure your QU is given the authority and resources to effectively function. The assessment should also include, but not be limited to:o A determination of whether procedures used by your firm are robust and appropriate.o Provisions for QU oversight throughout your operations to evaluate adherence to appropriate practices.o A complete and final review of each batch and its related information before the QU disposition decision.o Oversight and approval of investigations and discharging of all other QU duties to ensure identity, strength, quality, and purity of all products.A comprehensive, independent assessment of your overall system for investigating deviations, discrepancies, complaints, out-of-specification results, and failures. Provide a detailed action plan to remediate this system. Your action plan should include, but not be limited to, significant improvements in investigation competencies, scope determination, root cause evaluation, corrective action and preventive action (CAPA) effectiveness, QU oversight, and written procedures. Address how your firm will ensure all phases of investigations are appropriately conducted.A comprehensive, independent assessment and CAPA plan to ensure the adequacy of your stability program. Your remediated program should include, but not be limited to:o Stability indicating methods.o Stability studies for each drug product in its marketed container-closure system before distribution is permitted.o An ongoing program in which representative batches of each product are added each year to the program to determine if the shelf-life claim remains valid.o Detailed definition of the specific attributes to be tested at each station (timepoint).A complete assessment of documentation systems used throughout your manufacturing and laboratory operations to determine where documentation practices are insufficient. Include a detailed CAPA plan that comprehensively remediates your firm’s documentation practices to ensure you retain attributable, legible, complete, original, accurate, contemporaneous records throughout your operation.Responsibilities as a ContractorDrugs must be manufactured in conformance with CGMP. FDA is aware that many drug manufacturers use independent contractors such as production facilities, testing laboratories, packagers, and labelers. FDA regards contractors as extensions of the manufacturer.You are responsible for the quality of drugs you produce as a contract facility regardless of agreements in place with product owners. You are required to ensure that drugs are made in accordance with section 501(a)(2)(B) of the FD&C Act for safety, identity, strength, quality, and purity. See FDA’s guidance documentContract Manufacturing Arrangements for Drugs: Quality Agreementsat https://www.fda.gov/media/86193/download.CGMP Consultant RecommendedBased upon the nature of the violations we identified at your firm, you should engage a consultant qualified as set forth in 21 CFR 211.34 to evaluate your operations and to assist your firm in meeting CGMP requirements. The qualified consultant should also perform a comprehensive six-system audit1of your entire operation for CGMP compliance and evaluate the completion and efficacy of your CAPAs before you pursue resolution of your firm’s compliance status with FDA.Your use of a consultant does not relieve your firm’s obligation to comply with CGMP. Your firm’s executive management remains responsible for resolving all deficiencies and systemic flaws to ensure ongoing CGMP compliance.ConclusionThe violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations.Correct any violations promptly. Failure to promptly and adequately address this matter may result in regulatory or legal action without further notice including, without limitation, seizure and injunction. Unresolved violations may also prevent other Federal agencies from awarding contracts.Failure to address violations may also cause FDA to withhold issuance of Export Certificates. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to address any violations.This letter notifies you of our findings and provides you an opportunity to address the above deficiencies. After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any violations and to prevent their recurrence. In response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion.Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 3014581785 and ATTN: Matthew R. Dionne, Pharm.D.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and Research_____________________1i.e. Quality System, Facilities & Equipment System, Materials System, Production System, Packaging & Labeling System, and Laboratory Control System per FDA’s guidance document Quality Systems Approach to Pharmaceutical CGMP Regulations.