Delivery Method:Via EmailProduct:DrugsRecipient:Rene GonzalezOwnerRay’s Vitamins6528 Greenleaf Avenue, Ste. 204Whittier,CA90601United StatesGonzalezr33@yahoo.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERApril 24, 2026RE: 726694To Rene Gonzalez:This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at https://raysvitamins.com/ in April 2026. The FDA has observed that your website offers “Yeicob Ácido Hialurónico” for sale in the United States.1 In addition, FDA obtained a sample of “Yeicob Ácido Hialurónico” through your website, https://raysvitamins.com. Based on our review, this product is an unapproved new drug under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). As explained further below, introducing or delivering this product for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a). Furthermore, your “Yeicob Ácido Hialurónico” product is a misbranded drug under section 502 of the FD&C Act, 21 U.S.C. 352, and introduced or delivered for introduction into interstate commerce in violation of section 301(a) of the FD&C Act, 21 U.S.C. 331(a).FDA confirmed through laboratory analysis that a sample of your “Yeicob Ácido Hialurónico” product contains the undeclared active pharmaceutical ingredients diclofenac and dexamethasone. Diclofenac is a non-steroidal anti-inflammatory drug (NSAID). NSAIDs may cause increased risk of cardiovascular events, such as heart attack and stroke, as well as serious gastrointestinal damage, including bleeding, ulceration, and fatal perforation of the stomach and intestines. Diclofenac may also interact with other medications and significantly increase the risk of adverse events, particularly when consumers use multiple NSAID-containing products.Dexamethasone is a corticosteroid commonly used to treat inflammatory conditions. Corticosteroid use can impair a person’s ability to fight infections and can cause high blood sugar levels, muscle injuries and psychiatric problems. When corticosteroids are taken for a prolonged period, or at high doses, they can suppress the adrenal gland. Abrupt discontinuation can cause withdrawal symptoms. In addition, the undeclared dexamethasone in “Yeicob Ácido Hialurónico” may cause serious side effects when combined with other medications.Your “Yeicob Ácido Hialurónico” product is marketed as a dietary supplement, according to information found on the labels and/or labeling of the product. However, under section 201(ff)(3)(B)(i) of the FD&C Act, 21 U.S.C. 321(ff)(3)(B)(i), a dietary supplement may not include an article that is approved as a new drug under section 505 of the FD&C Act unless that article was marketed as a dietary supplement or food before its approval as a drug. FDA approved diclofenac under the trade name Voltaren as a new drug on July 28, 1988, and approved dexamethasone under the trade name Hexadrol, as a new drug on December 21, 1960. Given that diclofenac and dexamethasone were not marketed as dietary supplements or as a food before Voltaren and Hexadrol were approved, “Yeicob Ácido Hialurónico,” which contains diclofenac and dexamethasone, is excluded from the definition of a dietary supplement under section 201(ff)(3)(B)(i) of the FD&C Act, 21 U.S.C. 321(ff)(3)(B)(i).Moreover, we note regardless of whether your “Yeicob Ácido Hialurónico” product is excluded from the definition of a dietary supplement, it is a drug under section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because it is intended for, among other things, use as an arthritis treatment.Unapproved New DrugYour “Yeicob Ácido Hialurónico” product is a drug under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure or any function of the body.Examples from your product labeling, including on your website that provide evidence of the intended use (as defined in 21 CFR 201.128) of this product as a drug include, but may not be limited to, the following:On the webpage https://raysvitamins.com/product/yeicob-acido-hialuronico/:“How This Supplement Can Help You: Supports ligament and tendon function, lubricating and cushioning joint areas. Provides nutrients for joint health, including the cartilage [sic] and menisci. Helps adjust moisture absorption in the skin, preventing dehydration. Often used for joint or muscle pain related to arthritis.”Your “Yeicob Ácido Hialurónico” product is a “new drug” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because it is not generally recognized as safe and effective (GRASE) for use under the above-described conditions prescribed, recommended, or suggested in its labeling. With certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in section 505(a) of the FD&C Act, 21 U.S.C. 355(a). No approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for this product. Accordingly, this product is an unapproved new drug. The introduction or delivery for introduction into interstate commerce of this unapproved new drug product violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).Misbranded DrugYour “Yeicob Ácido Hialurónico” product is misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a). Under section 502(a) of the FD&C Act, 21 U.S.C. 352(a), a drug is misbranded if its labeling is false or misleading in any particular. Section 201(n) of the FD&C Act, 21 U.S.C. 321(n), provides that, in determining whether an article’s labeling or advertising “is misleading there shall be taken into account . . . not only representations made or suggested . . . but also the extent to which the labeling or advertising fails to reveal facts material in light of such representations.” The labeling for your “Yeicob Ácido Hialurónico” product does not declare that the product contains diclofenac and dexamethasone. As previously mentioned, these undeclared ingredients in your “Yeicob Ácido Hialurónico” product may pose serious health risks because consumers with underlying medical issues may take the product without knowing that it can cause serious harm or interact in dangerous ways with other drugs they may be taking. The failure to disclose these ingredients in the product labeling renders your “Yeicob Ácido Hialurónico” product misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a). The introduction or delivery for introduction into interstate commerce of this misbranded drug is a prohibited act under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).We also observed that your website https://raysvitamins.com/ offers “RM Joe”2 and “RMSOL GRACIAN”3 for sale to consumers in the United States. Previous FDA lab analyses of products similarly named to those sold on your website revealed these products contained undeclared drug ingredients. While the Agency has not sampled and tested these product variations from your inventory to date, this letter expresses our serious concern about the safety of these products. We emphasize that it is your legal responsibility under federal law to ensure that products you sell do not contain any undeclared or potentially harmful ingredients, and that they are marketed in compliance with applicable laws.ConclusionThe 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 firm complies with all requirements of federal law, including FDA regulations.This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may lead to regulatory or legal action including, without limitation, seizure and injunction.Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to correct any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. 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. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.Your response should be sent to U.S. Food and Drug Administration, CDER/OC/Office of Unapproved Drugs and Labeling Compliance by email to FDAAdvisory@fda.hhs.gov. Please include your firm name and the unique identifier “726694” in the subject line of the email.Sincerely,/S/Tina Smith, M.S.Captain, U.S. Public Health ServiceDirectorOffice of Unapproved Drugs and Labeling ComplianceOffice of ComplianceCenter for Drug Evaluation and ResearchFood and Drug Administration_________________________1FDA issued a warning to consumers not to use your “Yeicob Ácido Hialurónico” product (see: https://www.fda.gov/drugs/medication-health-fraud-notifications/yeicob-acido-hialuronico-may-be-harmful-due-hidden-drug-ingredients)2https://www.fda.gov/drugs/medication-health-fraud-notifications/rm-joe-may-be-harmful-due-hidden-drug-ingredients3https://www.fda.gov/drugs/medication-health-fraud/rmsol-gracian-contains-hidden-drug-ingredient

Delivery Method:VIA Electronic MailProduct:Medical DevicesRecipient:Mr. Neeraj JhaPresident/CEOUnetixs Vascular, Inc.6901 TPC Drive, Suite 300Orlando,FL32822United States(b)(4)Issuing Office:Center for Devices and Radiological HealthUnited StatesWARNING LETTERCMS # 724245April 15, 2026Dear Neeraj Jha:During an inspection of your firm, Unetixs Vascular, Inc., located in Warwick, RI from September 19, 2025, through December 4, 2025, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures vascular diagnostic ultrasound systems, including the ROODRA and 2CP devices. 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.Our inspection revealed that the MultiLab Series ROODRA and 2CP vascular diagnostic devices are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not 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 under section 520(g) of the Act, 21 U.S.C. § 360j(g). The devices are also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the device with its current modifications into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k). For a device requiring premarket approval, the notification required by section 510(k) is deemed satisfied when a PMA is pending before the agency [21 CFR 807.81(b)]. The kind of information that your firm needs to submit in order to obtain approval or clearance for the device 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 decide whether the product may be legally marketed.Specifically, the modified MultiLab Series ROODRA and 2CP vascular diagnostic devices that you are distributing do not have 510(k) clearance. While MultiLab Series ROODRA and 2CP vascular diagnostic devices have a prior 510(k) clearance (K904392), the modified devices include both design and labeling modifications – as documented in your firm’s “Regulatory Change Assessment - ENGINEERING CHANGE RECORD ECR # 0137 - Changing all applicable items from luer connections to bayonet connections” – which could significantly affect the safety and effectiveness of the device and, under 21 CFR 807.81(a)(3)(i), require a new 510(k) submission. Our review found that the change was implemented to significantly mitigate a known risk in response to an adverse event. Specifically, the device design, construction materials and labeling changes, to physically prevent device misconnections, were implemented to address a complaint of a death caused by air embolism.We also remind you on February 4, 2020, a Warning Letter, CMS Case #598016, was issued to you for significant quality system violations related to your vascular diagnostic ultrasound systems. We understand that while you have made progress in implementing corrective actions, deficiencies remain as documented during the recent inspection. You should continue to ensure that you are making further progress to be in compliance with all of our regulations. On February 2, 2024, the FDA issued a final rule amending the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) Regulation under 21 CFR 820 to align more closely with the international consensus standard for Quality Management Systems for medical devices used by many other regulatory authorities around the world. The revised part 820, referred to as the Quality Management System Regulation (QMSR), became effective on February 2, 2026. Your most recent inspection on September 19, 2025, through December 4, 2025, was conducted pursuant to the QS Regulation, which was in effect at the time of the inspection. However, any corrective actions you propose or implement must be pursuant to the QMSR requirements in effect as of February 2, 2026. For more information on the QMSR please refer to our frequently asked questions webpage: Quality Management System Regulation – Frequently Asked Questions. The 2020 Warning Letter will remain open until we verify that you have successfully implemented all necessary corrections.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.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 must 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 Gina Brackett, Assistant Director at CDRHEnforcement@fda.hhs.gov. Please include in the subject line, “CMS Case # 724245” when replying. If you have any questions about the contents of this letter, please contact: Karen Archdeacon at karen.archdeacon@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. 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. MarsdenDirectorOffice of Regulatory ProgramsOffice of Product Evaluation and QualityCenter for Devices and Radiological HealthCc:Vinod Ramani, Chairman, Opto Circuits (India) Ltd.(b)(4)John Haefele, Vice President, and General Manager,(b)(4)Denise Stone, Deputy General Manager,(b)(4)

Delivery Method:Via EmailProduct:DrugsRecipient:ibeautistore.com3042 Route 22 #38Dover Plains,NY12522-5920United Statessupport@ibeautistore.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERApril 24, 2026RE: 726302To ibeautistore.com:This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at https://ibeautistore.com/ in March 2026. The FDA has observed that your website offers “New Hyaluronic Acid 850 mg Sealed 30 Caps” for sale in the United States. In addition, FDA obtained a sample of “New Hyaluronic Acid 850 mg Sealed 30 Caps” through your website, https://ibeautistore.com/. The samples of your “New Hyaluronic Acid 850 mg Sealed 30 Caps” product were labeled as “Umary.” As such, this product will be hereinafter referred to as “Umary.”1Based on our review, this product is an unapproved new drug under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). As explained further below, introducing or delivering this product for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a). Furthermore, your “Umary” product is a misbranded drug under section 502 of the FD&C Act, 21 U.S.C. 352, and introduced or delivered for introduction into interstate commerce in violation of section 301(a) of the FD&C Act, 21 U.S.C. 331(a).FDA confirmed through laboratory analysis that a sample of your “Umary” product contains the undeclared active pharmaceutical ingredients diclofenac, dexamethasone, and omeprazole. Diclofenac is a non-steroidal anti-inflammatory drug (NSAID). NSAIDs may cause increased risk of cardiovascular events, such as heart attack and stroke, as well as serious gastrointestinal damage, including bleeding, ulceration, and fatal perforation of the stomach and intestines. Diclofenac may also interact with other medications and significantly increase the risk of adverse events, particularly when consumers use multiple NSAID-containing products.Dexamethasone is a corticosteroid commonly used to treat inflammatory conditions. Corticosteroid use can impair a person’s ability to fight infections and can cause high blood sugar levels, muscle injuries and psychiatric problems. When corticosteroids are taken for a prolonged period, or at high doses, they can suppress the adrenal gland. Abrupt discontinuation can cause withdrawal symptoms. In addition, the undeclared dexamethasone in “Umary” may cause serious side effects when combined with other medications.Omeprazole is a proton pump inhibitor (commonly referred to as PPI) used to treat gastric (stomach) acid-related disorders. PPI medicines may cause serious skin reactions, abdominal pain, diarrhea, nausea, and headache. Omeprazole may mask stomach issues such as erosions, ulcers, and stomach cancer, and it can also interact with other medications and should not be taken with certain medications.Your “Umary” product is marketed as a dietary supplement, according to information found on the labels and/or labeling of the product. However, under section 201(ff)(3)(B)(i) of the FD&C Act, 21 U.S.C. 321(ff)(3)(B)(i), a dietary supplement may not include an article that is approved as a new drug under section 505 of the FD&C Act unless that article was marketed as a dietary supplement or food before its approval as a drug. FDA approved diclofenac under the trade name Voltaren as a new drug on July 28, 1988, and approved dexamethasone under the trade name Hexadrol, as a new drug on December 21, 1960. Given that diclofenac and dexamethasone were not marketed as dietary supplements or as a food before Voltaren and Hexadrol were approved, “Umary,” which contains diclofenac and dexamethasone, is excluded from the definition of a dietary supplement under section 201(ff)(3)(B)(i) of the FD&C Act, 21 U.S.C. 321(ff)(3)(B)(i).Unapproved New DrugYour “Umary” product is a drug under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure or any function of the body.Examples from your product labeling, including on your website that provide evidence of the intended use (as defined in 21 CFR 201.128) of this product as a drug include, but may not be limited to, the following:On the webpage, https://ibeautistore.com/product/new-hyaluronic-acid-850mg-sealed-30-caps/:“What is hyaluronic acid?It [sic] is a polysaccharide found naturally in skin and cartilage cells. This crystalline substance has the function of hydrating the skin and joints, as it attracts and retains water molecules.”“As the body ages, the presence of hyaluronic acid in our body decreases considerably. This translates into an aging of the skin that is losing firmness and volume and, of course, in the appearance of dreaded wrinkles.”Your “Umary” product is a “new drug” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because it is not generally recognized as safe and effective (GRASE) for use under the above-described conditions prescribed, recommended, or suggested in its labeling. With certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in section 505(a) of the FD&C Act, 21 U.S.C. 355(a). No approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for this product. Accordingly, this product is an unapproved new drug. The introduction or delivery for introduction into interstate commerce of this unapproved new drug product violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).Misbranded DrugYour “Umary” product is misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a). Under section 502(a) of the FD&C Act, 21 U.S.C. 352(a), a drug is misbranded if its labeling is false or misleading in any particular. Section 201(n) of the FD&C Act, 21 U.S.C. 321(n), provides that, in determining whether an article’s labeling or advertising “is misleading there shall be taken into account . . . not only representations made or suggested . . . but also the extent to which the labeling or advertising fails to reveal facts material in light of such representations.” The labeling for your “Umary” product does not declare that the product contains diclofenac, dexamethasone, and omeprazole. As previously mentioned, these undeclared ingredients in your “Umary” product may pose serious health risks because consumers with underlying medical issues may take the product without knowing that it can cause serious harm or interact in dangerous ways with other drugs they may be taking. The failure to disclose these ingredients in the product labeling renders your “Umary” product misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a).The introduction or delivery for introduction into interstate commerce of this misbranded drug is a prohibited act under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).ConclusionThe 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 firm complies with all requirements of federal law, including FDA regulations.This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may lead to regulatory or legal action including, without limitation, seizure and injunction.Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to correct any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. 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. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.Your response should be sent to U.S. Food and Drug Administration, CDER/OC/Office of Unapproved Drugs and Labeling Compliance by email to FDAAdvisory@fda.hhs.gov. Please include your firm name and the unique identifier “726302” in the subject line of the email.Sincerely,/S/Tina Smith, M.S.Captain, U.S. Public Health ServiceDirectorOffice of Unapproved Drugs and Labeling ComplianceOffice of ComplianceCenter for Drug Evaluation and ResearchFood and Drug Administration____________________1FDA issued a warning to consumers not to use your “Umary” product (see: https://www.fda.gov/drugs/medication-health-fraud-notifications/umary-contains-hidden-drug-ingredients).

Delivery Method:Via EmailReference #:320-26-69Product:Drugs;Over-the-Counter DrugsRecipient:Mr. Roman ZimaChief Executive OfficerRespilon Production S.R.O.Prikop 843/4 Brno602 00JihomoravskyCzechiaIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter320-26-69April 20, 2026Dear Mr. Zima:Your facility is registered with the United States Food and Drug Administration (FDA) as a manufacturer of over-the-counter (OTC) drug products. FDA has reviewed the records you submitted in response to our May 2, 2025, request and subsequent correspondence, for records and other information pursuant to section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) for your facility, Respilon Production S.R.O, FEI 3018892481, at Prikop 843/4, Brno, Jihomoravsky, Czech Republic.This Warning Letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21, Code of Federal Regulations, parts 210 and 211 (21 CFR parts 210 and 211).Because your methods, facilities, or controls for manufacturing, processing, packing, or holding of drugs as described in your response to our 704(a)(4) request 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)).Following our review of records and other information you provided pursuant to section 704(a)(4) of the FD&C Act, significant violations were observed including but not limited to, the following:1. Your firm failed to conduct at least one test to verify the identity of each component of a drug product. 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)).Your response to our request for records under section 704(a)(4) indicated that you do not test the identity of each incoming component used in the manufacture of your drug products, such as(b)(4), before manufacturing.In addition, you failed to test each shipment of(b)(4)for(b)(4)contamination before use. Identity testing for(b)(4)and certain other high-risk drug components includes a limit test in the United States Pharmacopeia (USP) to ensure that the component meets the relevant safety limits for levels of(b)(4). Because you did not perform adequate identity testing on each shipment of each lot using the USP identification test that detects these hazardous impurities, you failed to ensure the acceptability of these components for use in the manufacturing of your drug product. See FDA’s guidance document(b)(4)for help in meeting the CGMP requirements when manufacturing drugs containing ingredients at high risk for(b)(4)contamination.2. Your firm failed to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products (21 CFR 211.166(a)).Your response to our request for records under section 704(a)(4) indicated that you have not performed stability studies for the OTC drug products you manufacture, despite your drug product’s displaying an expiration date on the label.Without the appropriate stability studies, you do not have scientific evidence to support whether your drug product’s active ingredient maintains its strength, purity, and quality throughout the shelf life of the product.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 (21 CFR 211.100(a)).Your response to our request for records under section 704(a)(4) indicated that you failed to adequately validate your drug manufacturing processes to demonstrate that they are reproducible and controlled. Process validation evaluates the soundness of design and the state of control of a process throughout its life cycle. Each significant stage of a manufacturing process must be designed appropriately and must ensure 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 to evaluate batches to determine whether an initial state of control has been established.4. Your firm failed to establish and document the accuracy, sensitivity, specificity, and reproducibility of its test methods (21 CFR 211.165(e)).Your response to our request for records under section 704(a)(4) indicated that you failed to adequately validate the test method used to analyze raw materials and finished drug products. Method validation or verification has not been completed for the active ingredient assay testing for(b)(4). Your analytical method does not demonstrate specificity, accuracy, precision, and robustness. Additionally, it appears that your firm is not performing microbiological testing for each batch of your drug products before release. In your response, you state that your drug product has low(b)(4)at less than(b)(4)and that microbial proliferation is not possible. However, you have not validated your overall manufacturing process or conducted stability studies to determine if microbial contamination proliferates throughout the shelf life of the product. You have not provided a comprehensive microbial risk assessment of your manufacturing steps, such as in-process hold times, storage conditions, and the microbial load of your(b)(4)ingredients. The statement in your response that you intend to conduct reduced microbial testing is insufficient, based on the limited information you provided and the lack of documentation to support your approach.5. Your firm failed to ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards (211.194(a)).Your response to our request for records under section 704(a)(4) indicated that your finished drug product’s Certificate of Analysis did not provide an individual test result for(b)(4)content. The “Batch Production” record that you provided as your Certificate of Analysis states “PASSED” in the “Conformity” section but does not provide an assay result.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 audit1 of your entire operation for CGMP compliance and evaluate the completion and efficacy of your corrective actions and preventive actions before you pursue resolution of your firm’s compliance status with FDA.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. 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 inspect to verify that you have completed corrective actions to any violations.Failure to address any violations may also result in the FDA refusing admission of articles manufactured at Respilon Production S.R.O., Prikop 843/4, Brno, Jihomoravsky, Czech Republic into the United States under section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3). Articles under this authority that appear to be adulterated may be detained or refused admission, in that the methods and controls used in their manufacture do not appear to conform to CGMP within the meaning of section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. 351(a)(2)(B).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 3018892481 and ATTN: Erika V. Butler.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and Research

波科国际医疗贸易（上海）有限公司报告，波士顿科学神经调控公司基于近期对于内部实验室检验结果的回顾，认为CSK 可重复使用的热偶电极在规定的 20次重复灭菌复用周期内，可能无法持续达到预期性能水平。截至目前，未收到该产品相关的境内不良事件报告。波科国际医疗贸易（上海）有限公司对其生产的射频消融治疗仪（注册证号：国械注进20183011615;国械注进20183251615）进行主动召回。召回级别为二级。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2026年05月04日

序号1企业名称辽宁咏和医药有限公司企业类型药品批发检查时间2026年4月23日-2026年4月25日,2026年4月28日-2026年4月28日所在地市抚顺市检查依据《药品管理法》、《麻醉药品和精神药品管理条例》、《药品经营和使用质量监督管理办法》、《药品经营质量管理规范》等法律、法规。检查事项药品经营检查检查方式常规检查检查内容执行GSP情况存在问题在设施设备方面，存在1个监测终端温度超限，未能够实现声光报警及报警上下限设置不合理等问题；在药品储存方面，存在堆码垛间距小的问题；在管理职责方面，存在质量部未能督促个别制度执行问题；在运输药品方面，存在未及时更新相关在用车辆资料问题。处理措施要求企业按照《药品经营监督检查缺陷整改指南》的规定进行整改。整改情况已按要求完成整改。序号2企业名称辽宁施福堂医药连锁有限公司企业类型药品零售连锁总部检查时间2026年4月20日-2026年4月22日,2026年4月29日-2026年4月29日所在地市抚顺市检查依据《药品管理法》、《药品经营和使用质量监督管理办法》、《药品经营质量管理规范》等法律、法规检查事项药品经营检查检查方式常规检查检查内容执行GSP情况存在问题在管理职责方面，存在未及时取消已离职人员权限问题；在质量管理文件方面，存在未制定门店间调拨相关制度及未及时修订《药品网络销售操作规程》等问题；在设施设备方面，存在1个温湿度测点终端不能实现声光报警问题；在收货验收方面，存在冷链药品接收单未标明运输方式问题。处理措施要求企业按照《药品经营监督检查缺陷整改指南》的规定进行整改。整改情况已按要求完成整改。

行政相对人名称 常州悦康医疗器材有限公司 行政相对人类别 法人及非法人组织 统一社会信用代码 91320402251013519F 工商注册号 组织机构代码 税务登记号 事业单位证书号 社会组织登记证号 法定代表人 陆巧琴 法定代表人证件类型 身份证 法定代表人证件号码 320************23 证件类型 证件号码 行政处罚决定书文号 苏药监常处罚〔2026〕12号 违法行为类型 违反《医疗器械监督管理条例》（国务院令第739号）第三十六条 违法事实 该公司于2025年5月至6月申报国内产品暂停生产期间生产并销售一次性使用无菌配药用注射器内销产品（注册证编号：苏械注准20172141151，型号规格：20ml，批号：20250521），经查，该公司因同一性质违法行为于2024年8月29日被我局责令立即改正违法行为，即立即停止在停产期间生产并销售医疗器械行为，并处以罚款人民币30000元的行政处罚，此次违法行为发生属于《医疗器械监督管理条例》（国务院令第739号）第八十八条第一项规定的拒不改正情形。 处罚依据 《医疗器械监督管理条例》（国务院令第739号）第八十八条第一项 处罚类别 罚款 处罚内容 罚款人民币柒万伍仟元整（75000元）。 罚款金额（万元） 7.5 没收违法所得没收非法财物的金额（万元） 暂扣或吊销证照名称及编号 处罚决定日期 2026/04/29 处罚有效期 2026/10/29 公示截止期 2029/04/29 处罚机关 江苏省药品监督管理局 处罚机关统一社会信用代码 11320000014000394R 数据来源单位 江苏省药品监督管理局 数据来源单位统一社会信用代码 11320000014000394R 备注

行政相对人名称石*行政相对人类别自然人证件类型身份证行政处罚决定书文号皖药监药处罚〔2025〕2-46-1号违法行为类型《中华人民共和国药品管理法》（2019年修订）第四十一条第一款违法事实从市场的流动摊位采购蜜款冬花以安徽孚众药业有限公司名义销售，经调查可以认定石*存在无证生产销售中药饮片的行为。暂扣或吊销证照名称及编号处罚依据《中华人民共和国药品管理法》（2019年修订）第一百一十五条处罚类别罚款;没收非法财物处罚名称石*无《药品生产许可证》生产销售中药饮片案处罚内容（1）没收违法所得829.92元；（2）罚款150000.00元，罚没共计150829.92元。罚款金额(万元)15没收违法所得、没收非法财物的金额(万元)0.082992处罚决定日期2026年4月30日处罚有效期公示截止期处罚行政机关安徽省药品监督管理局处罚机关统一社会信用代码11340000MB19570665数据来源单位安徽省药品监督管理局数据来源单位统一社会信用代码11340000MB19570665地方编码340000处罚状态有效备注

行政相对人名称安徽林生堂药业有限公司行政相对人类别法人及非法人组织行政相对人代码_1(统一社会信用代码)91341602MADN2X5C2W行政处罚决定书文号皖药监药处罚〔2025〕2-94号违法行为类型《中华人民共和国药品管理法》（2019年修订）第一百二十二条违法事实生产销售劣药川贝母暂扣或吊销证照名称及编号处罚依据《中华人民共和国药品管理法》（2019年修订）第一百一十七条第一款处罚类别罚款;没收违法所得;没收非法财物处罚名称安徽林生堂药业有限公司生产销售劣药川贝母案处罚内容1.没收劣药川贝母（批号250901）1.24kg；2.没收违法所得11750.88元；3.处罚款460000.00元；罚没款共计471750.88元。罚款金额(万元)46没收违法所得、没收非法财物的金额(万元)1.650544处罚决定日期2026年4月30日处罚有效期公示截止期处罚行政机关安徽省药品监督管理局处罚机关统一社会信用代码11340000MB19570665数据来源单位安徽省药品监督管理局数据来源单位统一社会信用代码11340000MB19570665地方编码340000处罚状态有效备注

企业名称辽宁天一优市美大药房连锁有限公司企业类型药品零售连锁总部检查时间2026年4月14日-2026年4月15日所在地市辽阳市检查依据《药品管理法》《药品经营质量管理规范》《药品经营和使用质量监督管理办法》等法律、法规。检查事项药品经营检查检查方式常规检查；专项检查。检查内容1.执行GSP情况； 2.辽宁省药品经营环节“清源”巩固提升行动专项检查。存在问题在人员与培训方面存在2026年培训计划部分内容缺失；在储存与养护方面存在个别药品混垛堆码等问题。处理措施限期整改。整改情况已按要求整改完毕。