佛山市兴斯医疗器械有限公司生产的低速涡轮牙科手机，生产批号见附件，因经广东省医疗器械质量监督检验所检验发现径向跳动不符合《低速涡轮牙科手机》产品技术要求相关规定。佛山市兴斯医疗器械有限公司决定发起召回。　　佛山市兴斯医疗器械有限公司对其生产的低速涡轮牙科手机（注册证号：粤械注准20182170111，生产批号：见附件）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》。　　附件：医疗器械召回事件报告表.pdf　　2026年3月3日

根据《中华人民共和国行政许可法》第七十条和《医疗器械监督管理条例》第六十六条的相关规定，按照《浙江省食品药品监督管理局办公室关于发布第二类医疗器械注册证书补办程序等5个相关工作程序的通知》（浙食药监规[2016]3号）的具体要求，依企业申请，现注销杭州康知生物科技有限公司“免疫球蛋白G4测定试剂盒（荧光免疫层析法）”（注册证编号：浙械注准20212400109）的医疗器械注册证书。 特此通告。 联系电话：0571-88903347 联系地址：杭州市莫干山路文北巷27号 邮编：310012 2026年3月3日

根据《中华人民共和国行政许可法》第七十条和《医疗器械监督管理条例》第六十六条的相关规定，按照《浙江省食品药品监督管理局办公室关于发布第二类医疗器械注册证书补办程序等5个相关工作程序的通知》（浙食药监规[2016]3号）的具体要求，依企业申请，现注销杭州昕磁科技有限公司“心磁图仪”（注册证编号：浙械注准20232071528）的医疗器械注册证书。 特此通告。 联系电话：0571-88903347 联系地址：杭州市莫干山路文北巷27号 邮编：310012 2026年2月24日

新春佳节，万家团圆。当浓浓年味洋溢大街小巷，省食药检院多名同志毅然放弃与家人团聚的时光，坚守工作岗位，以专业与坚守筑牢食药安全屏障，用责任与担当守护人民健康底线，保障检验研究工作连续高效推进。 一是前置部署筑防线。省食药检院早谋划、早部署，提前制定春节值守工作方案，实行24小时轮班值守机制，足额储备试剂耗材，开展应急处置演练，全方位夯实值守安全防线。严格规范样品接收、检测分析、报告发放全流程管理，同步开通应急绿色通道，以专业高效的技术服务为产业发展保驾护航，筑牢食药质量安全防线。 二是精准检验践使命。检验团队坚守一线，有序推进各项检验检测工作，重点开展重复给药毒性试验、保健食品功能试验、医疗机构制剂研究等重点项目。从精准给药、细致观察，到方法探索、严谨分析，再到实验数据实时采集、实验步骤详细记录，以及实验动物不间断规范饲养，每个环节都精益求精、一丝不苟，确保检测数据真实准确、检验结果可靠权威。 三是强化保障优服务。职能保障团队主动扛起服务保障重任，聚焦检验科研核心需求，精准发力做好服务支撑。工作人员主动加班加点，提供合规、高效、便捷的票据办理等服务，全程跟进对接服务需求，及时响应并妥善解决研究过程中的各类问题，全力保障重点项目有序推进，为检验研究工作筑牢服务保障根基。 食药安全无小事，技术攻坚不“打烊”。下一步，省食药检将以实验室为阵地，用责任和汗水筑牢安全防线，用坚守和奉献诠释“为民检验”的初心使命，彰显新时代食药检工作者的敬业精神与责任担当。

2026年国抽药品抽样委托书 委托单位：广西壮族自治区药品监督管理局。单位地址：南宁市青秀区云景路32号。法定代表人：李勇强，局长。          受委托单位：广西壮族自治区药品检验研究院。单位地址：南宁市青湖路9号。   法定代表人：周嵩煜，院长。委托依据：《药品质量抽查检验管理办法》（国药监药管〔2019〕34号）第十三条。委托事项：对广西壮族自治区行政区域内药品生产、经营和使用等环节的2026年国家药品抽检品种和中药材质量监测品种进行抽样。委托期限：2026年3月2日至2026年6月30日止。                    广西壮族自治区药品监督管理局     2026年3月2日

Delivery Method:VIA ELECTRONIC MAIL READ/DELIVERY RECEIPT REQUESTEDProduct:DrugsRecipient:Bliv Wellness LLC dba Bliv2411 Kiesel Ave. Ste 402Ogden,UT84401United Statessupport@joinbliv.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERFebruary 20, 2026Bliv: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.joinbliv.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 “Bliv” on the pictured label, suggesting Bliv is the compounder of those drugs when in fact it is not.2Accordingly, the representations on your website that Bliv 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)].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 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 also21 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:Belle Health LLC dba Belle621 E 12300 S Suite BDraper,UT84020United Statescare@joinbelle.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERFebruary 20, 2026Belle: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.joinbelle.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 “Belle” on the pictured label, suggesting Belle is the compounder of those drugs when in fact it is not.2Accordingly, the representations on your website that Belle 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)].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 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:Alan Health Technologies Inc. dba Alan249 Smith St., PMB 3008Brooklyn,NY11231United Stateslegal@alanmeds.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERFebruary 20, 2026Alan: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.alanmeds.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 “Alan” on the pictured label, suggesting Alan is the compounder of those drugs when in fact it is not.2Accordingly, the representations on your website that Alan 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)].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 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:BluefitMD1841 Lakewood Ranch BlvdLakewood Ranch,FL34211United Statessupport@bluefitmd.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERFebruary 20, 2026BluefitMD: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.bluefitmd.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 “BluefitMD” on the pictured label, suggesting BluefitMD is the compounder of those drugs when in fact it is not.2Accordingly, the representations on your website that BluefitMD 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:“Compounded Semaglutide (the same active ingredient as Ozempic® and Wegovy®)”“Compounded Tirzepatide (the same active ingredient as Mounjaro® & Zepbound®)”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:MEDVi, LLC dba MEDVi131 Continental Dr, Ste 305Newark,DE19713United Stateshelp@medvi.ioIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERFebruary 20, 2026MEDVi:This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website content at the internet address https://medvi.io, 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 “MEDVi” on the pictured label, suggesting MEDVi is the compounder of those drugs when in fact it is not.2Accordingly, the representations on your website that MEDVi 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:“Same active ingredient as Wegovy® and Ozempic®.”“Same active ingredient as Mounjaro® and Zepbound®.”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 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)].