Delivery Method:Via EmailProduct:Drugs、Over-the-Counter DrugsRecipient:Save Rite Medical168 10th StreetBrooklyn,NY11215United Statescs@saveritemedical.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERNovember 13, 2025RE: 717838Save Rite Medical:This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the internet address www.saveritemedical.com. The FDA has observed that your website offers the following triclosan-containing consumer and health care antiseptic nonprescription drug products: “Ameriderm AmeriWash Antimicrobial Lotion Soap with Triclosan 800 mL” and “Ameriderm AmeriWash Antimicrobial Lotion Soap with Triclosan 1000 mL” (hereinafter “Ameriderm Ameriwash Antimicrobial Lotion Soaps with Triclosan”) for sale in United States. Based on our review, these products are unapproved new drugs introduced or delivered for introduction into interstate commerce in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a) and 331(d). In addition, these products are misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee). Introduction or delivery for introduction of misbranded products into interstate commerce is prohibited under sections 301 (d) and (a) of the FD&C Act, 21 U.S.C. 331(d) and (a). These violations are described in more detail below.Unapproved New Drug and Misbranded Drug Violations“Ameriderm AmeriWash Antimicrobial Lotion Soaps with Triclosan” are “drugs” as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or under section 201(g)(1)(C) of the FD&C Act, 21 U.S.C. 321(g)(1)(C), because they are intended to affect the structure or any function of the body.Examples from the “Ameriderm AmeriWash Antimicrobial Lotion Soaps with Triclosan” product labeling, including your website, www.saveritemedical.com, that provide evidence of the intended use (as defined in 21 CFR 201.128) of the products as drugs include, but may not be limited to, the following:“Ameriderm AmeriWash Antimicrobial Lotion Soaps with Triclosan”“Antimicrobial…soap with Triclosan…made especially for the healthcare industry…for use in hospitals and nursing homes. •Kills bacteria on contact....” [from your website https://www.saveritemedical.com/products/ameriwash-antimicrobial-lotion-soap-with-triclosan-1000-ml]Based on the above labeling evidence, the “Ameriderm AmeriWash Antimicrobial Lotion Soaps with Triclosan” are intended for use as triclosan-containing consumer and health care antiseptic nonprescription drug products. As described below, these drug products are unapproved new drugs marketed in violation of sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d).A drug product is a “new drug” within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p), if it is not generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended, or suggested in its labeling; and in general, 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 FDA-approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for the drug products identified above.With respect to triclosan-containing consumer and health care antiseptic nonprescription drug products, such as the “Ameriderm AmeriWash Antimicrobial Lotion Soaps with Triclosan,” such products are subject to section 505G of the FD&C Act, 21 U.S.C. 355h, which governs nonprescription drugs marketed without an approved application. Specifically, these products fall under section 505G(a)(5) of the FD&C Act, 21 U.S.C. 355h(a)(5), because FDA has determined that topical consumer and health care antiseptic nonprescription drug products formulated with triclosan as an active ingredient are not GRASE under a final determination issued under 21 CFR part 330.1Therefore, these products are new drugs within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p). No FDA-approved application pursuant to section 505 of the FD&C Act is in effect for these drug products. Accordingly, these products are unapproved new drugs marketed in violation of section 505(a) of the FD&C Act, 21 U.S.C. 355(a). Introduction or delivery for introduction of such products into interstate commerce is prohibited under section 301(d) of the FD&C Act, 21 U.S.C. 331(d).In addition, the “Ameriderm AmeriWash Antimicrobial Lotion Soaps with Triclosan” are misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee), because these products are nonprescription drugs subject to section 505G of the FD&C Act, 21 U.S.C. 355h, but do not comply with the requirements for marketing under that section and are not the subject of an application approved under section 505 of the FD&C Act, 21 U.S.C. 355.The introduction or delivery for introduction of a misbranded drug into interstate commerce violates 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 list 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 result in legal action including, without limitation, seizure and injunction.Please notify FDA in writing, within 15 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 15 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 “717838” 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 ResearchU.S. Food and Drug Administration_________________1On September 6, 2017, FDA issued a final rule establishing that certain ingredients for OTC topical consumer antiseptic wash nonprescription drug products, including triclosan, are not generally recognized as safe and effective (81 FR 61106). FDA’s final determination was codified in regulations at 21 CFR 310.545(a)(27)(iii). On December 20, 2018, FDA issued a final rule establishing that certain ingredients for OTC health care antiseptic hand wash nonprescription drug products, including triclosan, are not generally recognized as safe and effective (82 FR 60474). FDA’s final determination was codified in regulations at 21 CFR 310.545(a)(27)(vi). Under section 505G(k)(2)(A) of the FD&C Act, the non-monograph conditions in 21 CFR 310.545 in effect on the day before the date of enactment of the CARES Act (i.e., March 26, 2020) were deemed to be a final administrative order. The final administrative order is entitled “Non-Monograph Conditions NM900: Drug Products Containing Certain Active Ingredients Offered Over-the-Counter for Certain Uses” (See Order ID OTC 000007, available at OTC Monographs@FDA, https://www.accessdata.fda.gov/scripts/cder/omuf/).

Delivery Method:Via EmailProduct:DrugsRecipient:Medical Mega208 Fairmont AveJersey City,NJ07306United StatesSales@medicalmega.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERNovember 13, 2025RE: 717840Medical Mega:This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the internet address https://www.medicalmega.com. The FDA has observed that your website offers the following triclosan-containing consumer and health care antiseptic nonprescription drug products: “Ameriderm AmeriWash Antimicrobial Lotion Soap with Triclosan 800 mL,” “Ameriderm AmeriWash Antimicrobial Lotion Soap with Triclosan 1 Gallon,” and “Ameriderm AmeriWash Antimicrobial Lotion Soap with Triclosan 1000 mL” (hereinafter “Ameriderm AmeriWash Antimicrobial Lotion Soaps with Triclosan”) for sale in United States. Based on our review, these products are unapproved new drugs introduced or delivered for introduction into interstate commerce in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a) and 331(d). In addition, these products are misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee). Introduction or delivery for introduction of misbranded products into interstate commerce is prohibited under sections 301 (d) and (a) of the FD&C Act, 21 U.S.C. 331(d) and (a). These violations are described in more detail below.Unapproved New Drug and Misbranded Drug Violations“Ameriderm AmeriWash Antimicrobial Lotion Soaps with Triclosan” are “drugs” as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or under section 201(g)(1)(C) of the FD&C Act, 21 U.S.C. 321(g)(1)(C), because they are intended to affect the structure or any function of the body.Examples from the “Ameriderm AmeriWash Antimicrobial Lotion Soaps with Triclosan” product labeling, including your website, https://www.medicalmega.com, that provide evidence of the intended use (as defined in 21 CFR 201.128) of the products as drugs include, but may not be limited to, the following:“Ameriderm AmeriWash Antimicrobial Lotion Soaps with Triclosan”“Anti-microbial…Kills bacteria on contact…” [from your https://medicalmega.com/AmeriWash-Antimicrobial-Lotion-Soap-with-Triclosan-1000-mL product page]Based on the above labeling evidence, the “Ameriderm AmeriWash Antimicrobial Lotion Soaps with Triclosan” are intended for use as triclosan-containing consumer and health care antiseptic nonprescription drug products. As described below, these drug products are unapproved new drugs marketed in violation of sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d).A drug product is a “new drug” within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p), if it is not generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended, or suggested in its labeling; and in general, 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 FDA-approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for the drug products identified above.With respect to triclosan-containing consumer and health care antiseptic nonprescription drug products, such as the “Ameriderm AmeriWash Antimicrobial Lotion Soaps with Triclosan,” such products are subject to section 505G of the FD&C Act, 21 U.S.C. 355h, which governs nonprescription drugs marketed without an approved application. Specifically, these products fall under section 505G(a)(5) of the FD&C Act, 21 U.S.C. 355h(a)(5), because FDA has determined that topical consumer and health care antiseptic nonprescription drug products formulated with triclosan as an active ingredient are not GRASE under a final determination issued under 21 CFR part 330.1Therefore, these products are new drugs within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p). No FDA-approved application pursuant to section 505 of the FD&C Act is in effect for these drug products. Accordingly, these products are unapproved new drugs marketed in violation of section 505(a) of the FD&C Act, 21 U.S.C. 355(a). Introduction or delivery for introduction of such products into interstate commerce is prohibited under section 301(d) of the FD&C Act, 21 U.S.C. 331(d).In addition, the “Ameriderm AmeriWash Antimicrobial Lotion Soaps with Triclosan” are misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee), because these products are nonprescription drugs subject to section 505G of the FD&C Act, 21 U.S.C. 355h, but do not comply with the requirements for marketing under that section and are not the subject of an application approved under section 505 of the FD&C Act, 21 U.S.C. 355.The introduction or delivery for introduction of a misbranded drug into interstate commerce violates 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 list 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 result in legal action including, without limitation, seizure and injunction.Please notify FDA in writing, within 15 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 15 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 “717840” 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 ResearchU.S. Food and Drug Administration_________________1On September 6, 2017, FDA issued a final rule establishing that certain ingredients for OTC topical consumer antiseptic wash nonprescription drug products, including triclosan, are not generally recognized as safe and effective (81 FR 61106). FDA’s final determination was codified in regulations at 21 CFR 310.545(a)(27)(iii). On December 20, 2018, FDA issued a final rule establishing that certain ingredients for OTC health care antiseptic hand wash nonprescription drug products, including triclosan, are not generally recognized as safe and effective (82 FR 60474). FDA’s final determination was codified in regulations at 21 CFR 310.545(a)(27)(vi). Under section 505G(k)(2)(A) of the FD&C Act, the non-monograph conditions in 21 CFR 310.545 in effect on the day before the date of enactment of the CARES Act (i.e., March 26, 2020) were deemed to be a final administrative order. The final administrative order is entitled “Non-Monograph Conditions NM900: Drug Products Containing Certain Active Ingredients Offered Over-the-Counter for Certain Uses” (See Order ID OTC 000007, available at OTC Monographs@FDA, https://www.accessdata.fda.gov/scripts/cder/omuf/).

Delivery Method:VIA UNITED PARCEL SERVICE AND VIA E-MAILProduct:DrugsRecipient:Ajay S. PatelCEOVerdure Sciences, Inc.17150 Metro Park CourtNoblesville,IN46060-4051United StatesIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERFDA Ref. No.: 25-HFD-45-11-01Dear Mr. Patel:This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted between June 25 and July 12, 2024. The investigators representing FDA reviewed the role of Verdure Sciences, Inc. (Verdure) as the sponsor of a clinical investigation (Protocol 005, “Randomized, Double-Blind Evaluation of Maple leaf extract (Maplifa for Photoaging”) of the investigational drug Maplifa® (1% or 5%).This inspection was conducted as a part of FDA’s Bioresearch Monitoring Program, which includes inspections designed to evaluate the conduct of research and to help ensure that the rights, safety, and welfare of human subjects have been protected.At the conclusion of the inspection, the FDA investigators presented and discussed with you the Form FDA 483, Inspectional Observations. We acknowledge receipt of your July 24, 2024, written response to the Form FDA 483.From our review of the FDA Establishment Inspection Report, the documents submitted with that report, and your July 24, 2024, written response, it appears that you did not adhere to the applicable statutory requirements in the Federal Food, Drug, and Cosmetic Act (FD&C Act) and applicable regulations contained in Title 21 of the Code of Federal Regulations, part 312 (21 CFR 312), governing the conduct of clinical investigations and the protection of human subjects. We wish to emphasize the following:You failed to submit an Investigational New Drug application (IND) for the conduct of a clinical investigation with an investigational new drug that is subject to 21 CFR 312.2(a) [21 CFR 312.20(a), 312.20(b), and 312.40(a)].FDA regulations require a sponsor to submit, and to have in effect, an IND before initiating a clinical investigation of a drug that is subject to 21 CFR 312.2(a) [see 21 CFR 312.20(a) and (b) and 312.40(a)] in human subjects, unless the clinical investigation qualifies for an IND exemption under 21 CFR 312.2. Verdure failed to comply with these requirements. Specifically, Verdure initiated Protocol 005, a clinical investigation of the investigational drug Maplifa®, which is subject to section 505 of the FD&C Act [21 U.S.C. 355], without submitting and having in effect an IND.In Verdure’s July 24, 2024, written response to the Form FDA 483, you stated that Verdure did not believe an IND was required because Protocol 005 assessed the use of topical Maplifa® skin regimen on the cosmetic appearance of skin photoaging (wrinkles and skin brightness). You further stated that the study ingredient was not being studied for use to affect the structure or function of the body or to prevent, treat, mitigate, cure, or diagnose a disease because Protocol 005’s primary endpoint was to detect change in skin brightness as measured by a skin colorimeter and facial photographic image analysis, which are widely used to study the efficacy of cosmetic formulations. Furthermore, you stated that the study met all the IND exemption requirements as listed in an FDA proposed rule1that proposed exemptions for certain clinical investigations of products lawfully marketed as a food or cosmetic when the product is to be studied to evaluate its use as a drug. Finally, you stated that Verdure signed a Clinical Study Agreement (CSA) with a third-party vendor to conduct Protocol 005, and the CSA transferred the obligation of the “sponsor” to this third party.We address your arguments below.1. Protocol 005 was a clinical investigation of a drug subject to 21 CFR 312.Section 201(g)(1) of the FD&C Act [21 U.S.C. 321(g)(1)] definesdrug, in part, as “articles (other than food) intended to affect the structure or any function of the body of man or other animals….” Whether an investigational article is a drug depends on the intended use of the article in the investigation. Based on Protocol 005 and the final study report, the investiga-tional product, Maplifa®, as used in this clinical investigation, was a drug as defined in section 201(g)(1) of the FD&C Act because Maplifa® was studied for use in the mitigation or treatment of facial wrinkles, skin brightness, skin redness, erythema, and hyperpigmentation.Specifically, as described in the protocol, the objective of Protocol 005 was to “examine the effects of topical Maplifa® on facial wrinkles, redness, and pigmentation.” The final study report for Protocol 005 also stated that “Maplifa® is a proprietary, standardized, phenolic-enriched A[cer]rubrumextract formula that is intended to whiten skin and reduce wrinkle production, primarily due to its anti-oxidative and anti-glycating properties.” The final study report further stated, “To further understand the influence of applying topicalA. rubrum-based products to the skin, we conducted a randomized, double-blind evaluation to explore the influence of [glucitol-core containing gallotannins] on reduction of face redness, hyperpigmen-tation, and wrinkle formation.” According to the protocol and the final study report, to assess the efficacy of Maplifa®, Protocol 005’s outcome measures included changes in skin brightness, pigmentation, erythema, redness, and wrinkles. These outcomes were measured using different methods, including skin colorimeter, image-based analysis, and in-person clinical assessments. Therefore, Protocol 005 collected study data to assess the effect of Maplifa® on the skin, as measured by methods including skin colorimeter and facial photographic image analysis.Considering the nature of the study, as described above, we conclude that the evidence collected during the inspection shows that Maplifa® was intended to affect the structure or function of the body; it was not merely intended to affect cosmetic appearance. Maplifa® was therefore intended for use as a drug for the clinical investigation conducted under Protocol 005. As a result, you were required to submit an IND before conducting the clinical investigation.2. The clinical investigation conducted under Protocol 005 does not meet the exemption criteria in 21 CFR 312.2(b)(1) and is subject to the IND requirements under 21 CFR 312.FDA regulations require a sponsor to submit an IND before conducting a clinical investigation of a drug in human subjects, unless the clinical investigation qualifies for an IND exemption under 21 CFR 312.2(b). Under 21 CFR 312.2(b)(1), the clinical investigation of a lawfully marketed drug product in the United States is exempt from the IND regulations for a clinical investigation if all the exemption criteria in 21 CFR 312.2(b) are met.Protocol 005 does not qualify for any of the exemptions listed at 21 CFR 312.2 from the application of 21 CFR 312. To be IND-exempt under 21 CFR 312.2, the investigational product must be lawfully marketed in the United States as a drug product. Verdure’s July 24, 2024, written response claims that Maplifa® is marketed only as a cosmetic ingredient, not as a drug product. However, as described above, the intended use of Maplifa® under Protocol 005 was as a drug, and we are not aware of any basis to conclude that it is a lawfully marketed drug. You also argue that Maplifa® is exempt from the IND requirements based on an FDA proposed rule. However, your response provided no reasoning to support this assertion. A proposed rule, until final, is not binding and does not supersede or otherwise change existing FDA regulations regarding IND exemptions. Your response also did not explain why Protocol 005 would have qualified for an exemption, even if the proposed rule were final and in effect. Moreover, we note that study participants received the study drug and the study was completed before FDA proposed the regulation at issue for public comment. As explained above, the study materials for Protocol 005 establish that Maplifa®’s intended use in the clinical trial was that of a drug. Further, Protocol 005 was not exempt from 21 CFR 312, and Verdure was required to submit an IND before initiating a clinical investigation of a drug in human subjects.3. Verdure is the sponsor of the clinical investigation conducted under Protocol 005 as defined in 21 CFR 312.3.FDA regulations define a sponsor as a person who takes responsibility for and initiates a clinical investigation [see 21 CFR 312.3]. Under 21 CFR 312.52, a sponsor may transfer responsibility for any or all of its obligations to a Contract Research Organization (CRO) and must describe any such transfer, including the specific obligations transferred, in writing; however, if all obligations are transferred, a general statement that all obligations have been transferred is acceptable. Both the CSA and the work order collected during the inspection and provided in your written response identify Verdure Sciences, Inc., as the “Sponsor” and the third-party vendor as the “Service Provider.” Neither of these documents describes which of Verdure’s sponsor obligations for conducting this study, if any, were transferred to the third-party vendor. Additionally, the CSA and work order do not contain any general statements that sponsor obligations have been transferred. Your written response refers to a provision of the CSA, which states that the third-party vendor “will conduct the Study according to the provisions of the Protocol and this Agreement and in conformance with all [Applicable Laws].” This provision does not describe, in either general or specific terms, any obligations that transferred from you to the third-party vendor.In your written response, you stated that as a corrective and preventive action, Verdure will ensure that all third parties, such as a CRO, comply with all applicable FDA regulations, including filing for an IND, unless exempt. However, your written response is inadequate because it does not provide sufficient details of a corrective and preventive action plan for developing and implementing procedures that comply with IND regulations, should Verdure decide in the future to initiate another clinical investigation for which an IND is required. Without this information, we are unable to determine whether Verdure will comply with IND regulations in the future.As a sponsor, you are responsible for complying with IND requirements, including submitting and having in effect an IND before initiating a clinical investigation, and it is Verdure’s responsibility, as a sponsor, to be aware of and to follow all applicable FDA regulations. Verdure’s failure to submit, and to have in effect, an IND before initiating Protocol 005 with an investigational drug raises significant concerns about the safety and welfare of enrolled subjects, and raises concerns about the validity and integrity of the data collected during the conduct of this clinical investigation.This letter is not intended to be an all-inclusive list of deficiencies with your clinical study of an investigational drug. It is your responsibility to ensure adherence to each requirement of the law and relevant FDA regulations. You should address any deficiencies and establish procedures to ensure that any ongoing or future studies comply with FDA regulations.This letter notifies you of our findings and provides you with an opportunity to address the deficiencies noted above. Within 15 business days of your receipt of this letter, you should notify this office in writing of the actions you have taken to prevent similar violations in the future. Failure to address this matter adequately may lead to regulatory action. If you believe that you have complied with the FD&C Act and relevant regulations, please include your reasoning and any supporting information for our consideration.Should you have any questions or concerns about this letter or the inspection, please email FDA at CDER-OSI-Communications@fda.hhs.gov. Your written response and any pertinent documentation should be addressed to:Brittany L. Garr, MPHBranch ChiefCompliance Enforcement BranchDivision of Enforcement and Postmarketing SafetyOffice of Scientific InvestigationsOffice of ComplianceCenter for Drug Evaluation and ResearchU.S. Food and Drug AdministrationBuilding 51, Room 535210903 New Hampshire AvenueSilver Spring, MD 20993Sincerely yours,/S/David C. Burrow, Pharm.D., J.D.DirectorOffice of Scientific InvestigationsOffice of ComplianceCenter for Drug Evaluation and ResearchU.S. Food and Drug Administration____________________1Federal Register Proposed Rule - December 9, 2022.

为进一步优化化妆品（含牙膏，下同）标签管理工作，满足消费者知情权和适老化需求，服务企业生产经营便利化，助力化妆品产业高质量发展，根据《国家药监局关于开展化妆品电子标签试点工作的通知》（国药监妆〔2025〕16号）（以下简称《通知》）要求，市药品监管局决定开展化妆品电子标签试点工作。现将有关事项通告如下：  一、试点范围  试点工作自2026年2月1日起，为期3年。注册地址位于本市的化妆品注册人、备案人或经境外化妆品注册人、备案人授权的境内责任人，经市药品监管局遴选确认后可试点通过电子标签方式标注化妆品中文标签。  试点企业可选择自行建设电子标签系统，或使用第三方技术机构建设的电子标签系统。  二、参与试点申报流程  有意向在本市参与电子标签试点的企业，请于2025年12月15日前提交《上海市化妆品电子标签试点企业申报表》（附件1）至企业注册地所在区市场监督管理局（附件2）。各相关区市场监管局对符合《通知》要求条件的企业结合日常监管情况择优向市药品监管局推荐。市药品监管局对各区推荐的企业评估后确定首批试点企业名单，及时通过官方网站对外公布。  三、试点期间的监管要求  1. 市药品监管局组织推进全市化妆品电子标签试点工作，加强对试点企业的督促指导。各区市场监管局负责辖区试点工作的宣贯指导、沟通服务、试点企业推荐等工作。上海市医疗器械化妆品审评核查中心及各区市场监管局依职责对使用电子标签的化妆品开展备案整理和备案后检查工作。  2. 试点企业应当严格按照《通知》要求开展电子标签试点。电子标签系统、电子标签二维码和展示内容应当符合《化妆品监督管理条例》《化妆品标签管理办法》以及《通知》的相关要求，保证电子标签的合法性、准确性、完整性、连续性、及时性、可获得性和可追溯性。对未按化妆品电子标签试点工作要求开展试点的企业，按照国家化妆品电子标签试点有关工作要求处理。  3. 试点企业在试点过程中应不断总结经验，完善相关管理制度。企业因系统建设等原因无法继续开展试点的，应及时向所在区市场监管局报告终止试点。  4. 市药品监管局加强试点实施情况的跟踪，对区市场监管局反映的辖区试点实施情况，试点企业遇到的问题进行研究，推动试点顺利开展。  特此通告。  上海市药品监督管理局  2025年11月14日

Delivery Method:VIA Electronic MailReference #:320-26-13Product:DrugsRecipient:Mr. Andrew CriglingtonChief Executive OfficerMiers Laboratories, Ltd32 Waiu Street, Wainuiomata Lower HuttWellington5014New Zealandac@mierslabs.co.nzIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter320-26-13November 3, 2025Dear Mr. Criglington:The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Miers Laboratories, Ltd, FEI 3004087508, at 32 Waiu Street, Wainuiomata, Lower Hutt, Wellington, from May 19 to 21, 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 have not yet received a response from your firm stating the actions you are taking to address the deficiencies identified during the inspection and cited on our Form FDA 483.During our inspection, our investigator observed specific violations 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)).You manufacture homeopathic drug products, several of which are intended for use in(b)(4). You failed to perform adequate identity testing on incoming components used in the manufacture of your homeopathic drug products. You solely relied on your suppliers’ certificates of analysis (COAs) without establishing the reliability of your component suppliers’ test analyses at appropriate intervals.(b)(4)You failed to perform identity testing on a batch of(b)(4)containing up to(b)(4)%(b)(4). You used this material as a solvent for(b)(4)tablets with homeopathic active pharmaceutical ingredients to manufacture numerous drug product batches for the U.S. market. The United States Pharmacopeia identity test for(b)(4)includes a(b)(4)limit of(b)(4)ppm. Your use of(b)(4)with(b)(4)is unacceptable.You manufacture multiple drugs that contain(b)(4). The use of(b)(4)has resulted in various lethal poisoning incidents in humans worldwide. See(b)(4)Homeopathic active pharmaceutical ingredientsYou failed to perform adequate testing on homeopathic active pharmaceutical ingredients. For example, you used a batch of(b)(4)that was more than 14 years past its expiration to manufacture numerous batches of finished drug products without determining whether the component continued to meet quality attributes.Without appropriate testing of incoming components, you cannot verify that the identity, purity, strength, quality, and safety of components meet specifications, and cannot confirm their suitability for intended use.This is a repeat violation from your 2019 inspection.In response to this letter, provide:A comprehensive review of your material system to determine whether all suppliers of components, containers, and closures, are each qualified and the materials are assigned appropriate expiration or retest dates. The review should also determine whether incoming material controls are adequate to prevent use of unsuitable components, containers, and closures.The chemical and microbiological quality control specifications you use to test and release each incoming lot of components for use in manufacturing.A description of how you will test each component lot for conformity with all appropriate specifications for identity, strength, quality, and purity. If you intend to accept any results from your suppliers’ COAs instead of testing each component lot for strength, quality, and purity, specify how you will robustly establish the reliability of your suppliers’ results through initial validation as well as periodic re-validation. In addition, include a commitment to always conduct at least one specific identity test for each incoming component lot.A summary of your program for qualifying and overseeing contract facilities that test the drug products you manufacture.A summary of results obtained from testing reserve samples of finished products on the U.S. market for(b)(4)content. If such testing identifies drug products with unacceptable(b)(4)levels, take rapid corrective actions such as notifying customers and product recalls.2. Your firm’s quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22).During the inspection, our investigator observed that your quality unit (QU) did not provide adequate oversight for the manufacture of your homeopathic drug products. Your QU failed to ensure the following:Appropriate batch production and control records that include documentation of the accomplishment of each significant step in manufacturing of your drug products (21 CFR 211.188(b)). This is a repeat violation from your 2014 and 2019 inspections.Establishment of written procedures for managing quality unit functions including deviations, investigations, and corrective actions and preventive actions (21 CFR 211.22(d)). This is a repeat violation from you 2019 inspection.Establishment of an adequate quality control unit to approve or reject components and drug products (21 CFR 211.22(a)).Your firm’s quality systems are inadequate. See FDA’s guidance documentQuality Systems Approach to Pharmaceutical CGMP Regulationsfor help 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/regulatory-information/search-fda-guidance-documents/quality-systems-approach-pharmaceutical-current-good-manufacturing-practice-regulations.In response to this letter, provide the following: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 appropriateo Provisions for QU oversight throughout your operations to evaluate adherence to appropriate practiceso A complete and final review of each batch and its related information before the QU disposition decisiono Oversight and approval of investigations and discharging of all other QU duties to ensure identity, strength, quality, and purity of all products.Repeat Violations at FacilityIn a previous inspection, performed June 17 to 21, 2019, FDA cited similar CGMP observations. You acknowledged these observations and informed our investigators that you would correct all observations during the closeout meeting. Despite these commitments, when FDA reinspected your facility, the violations had not been corrected. Repeated failures demonstrate that executive management oversight and control over the manufacture of drugs is inadequate.CGMP Consultant RecommendedBecause you failed to correct repeat violations, you should engage a consultant qualified as set forth in 21 CFR 211.34 to assist your firm in meeting CGMP requirements.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.FDA placed all drugs and drug products offered for import into the United States from your firm on Import Alert 66-40 on October 27, 2025.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 re-inspect to verify that you have completed corrective actions to any violations.Failure to address any violations may also result in the FDA continuing to refuse admission of articles manufactured at Miers Laboratories, Ltd., at 32 Waiu Street, Wainuiomata, Lower Hutt, Wellington, 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 3004087508 and ATTN: Emily Wu.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and Research

根据原国家食品药品监管总局国家卫生计生委《关于进一步加强疫苗流通监管促进疫苗供应工作的通知》（食药监药化监〔2017〕76号）精神，现就复星雅立峰(大连)生物制药有限公司委托储存配送信息通告如下，请有关药品监管部门加强监管。委托企业名称委托企业注册地址委托品种目录被委托企业名称被委托企业注册地址被委托企业仓库地址委托配送区域委托配送合同有效期复星雅立峰(大连)生物制药有限公司辽宁省大连市经济技术开发区铁山中路1号流感病毒裂解疫苗 每瓶(支)0.25ml;每瓶(支)0.5ml国药准字S200530912-8℃ 冻干人用狂犬病疫苗(Vero细胞)复溶后每瓶0.5ml国药准字S202400072-8℃四价流感病毒裂解疫苗0.5ml/支国药准字S202500322-8℃江西五洲医药营销有限公司江西省宜春市樟树市四特大道71号江西省宜春市樟树市四特大道71号江西省2025年11月10日至2025年12月31日

近日，省食品药品检验所通过中国合格评定国家认可委员会（CNAS）实验室认可资质扩项，检测能力范围新增46个项目，主要覆盖生物制品检验项目参数。此前，CNAS派出评审组专家一行5人到省食品药品检验所进行CNAS扩项现场评审。评审组通过现场检查、审阅资料、见证实验等方式，对省食品药品检验所申请认可的46项检检测能力和技术要素开展评审，并为省食品药品检验所生物制品检测相关的质量管理体系内容提出了优化改进建议。通过生物制品检测相关的CNAS参数扩项，省食品药品检验所满足了下一步申请批签发资质的检测能力条件。省食品药品检验所将在省药监局领导下，深入贯彻党的二十届三中、四中全会精神，进一步落实落细生物制品批签发资质申请工作责任，切实提高生物制品实验室质量管理水平，为我省药品监管事业提供更为坚实有力的技术支撑，为我省生物制品产业高质量发展贡献力量。

按照《医疗器械网络销售监督管理办法》有关规定，根据企业申请，我局现依法取消大连仟任科技发展有限公司｛备案编号：（辽）网械平台备字〔2021〕第00001号，网站名称：大连仟任科技，网站域名：qianrenjiankang.com｝、麦斯信通科技（大连）有限公司｛备案编号：（辽）网械平台备字〔2022〕第00001号，网站名称：药品会，网站域名：yaopshop.com｝的医疗器械网络交易服务第三方平台备案。 特此公告。 辽宁省药品监督管理局 2025年11月17日

关于河南省牵头省际联盟集采部分中选药品信息变更的通知（第一批）有关单位：按照《关于河南省牵头省际联盟集采部分中选药品信息变更的通知（第一批）》要求，现将中选企业、中选药品有关信息予以调整，详见附件。附件∶河南省牵头省际联盟集采部分中选药品信息变更情况（第一批）项目名称产品代码医保编码通用名剂型规格包装药品批准文号变更后中选企业信息变更后生产企业信息变更说明十七省（区、兵团）药品联盟接续带量采购项目3110170XR03DAD179B002010404610多索茶碱注射剂10ml*0.1g/支国药准字H20234452浙江北生药业汉生制药有限公司浙江北生药业汉生制药有限公司变更中选企业、生产企业。中选企业、生产企业均由“浙江佰奥医药科技有限公司”变更为“浙江北生药业汉生制药有限公司”十七省（区、兵团）药品联盟接续带量采购项目160164XM01AEB173B002010304494布洛芬注射剂4ml*0.4g/支国药准字H20203317陕西丽彩药业有限公司杭州民生药业股份有限公司、酒泉大得利制药股份有限公司新增生产企业。生产企业增加“酒泉大得利制药股份有限公司”十七省（区、兵团）药品联盟接续带量采购项目160166XM01AEB173B002020204494布洛芬注射剂8ml*0.8g/支国药准字H20203318陕西丽彩药业有限公司杭州民生药业股份有限公司、酒泉大得利制药股份有限公司新增生产企业。生产企业增加“酒泉大得利制药股份有限公司”十九省（区、兵团）药品联盟集中带量采购项目2001688XC01DAX072B002030102902硝酸甘油注射剂5ml：25mg国药准字H20237047山西康宝生物制品股份有限公司山西康宝生物制品股份有限公司新增中选规格。5ml：25mg中选价格为25.92元/支2025年11月18日

行政相对人名称***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)***法定代表人***行政处罚决定书文号粤药监械罚〔2025〕5001号违法行为类型生产不符合标准的医疗器械热敷贴违法事实2022年9月20日，当事人生产了热敷贴[批号：220901 29，规格：Ⅰ型（190mm×70mm）]10000盒（规格：2贴/盒），经广西壮族自治区医疗器械检测中心检验（报告编号：2023CJ020299）和广东省医疗器械质量监督检验所复检（报告编号：WT24020141）均不合格。处罚依据《医疗器械监督管理条例》第八十六条第一项处罚类别罚款;没收违法所得；没收非法财物处罚内容1.没收违法生产的医疗器械热敷贴446盒；2.没收违法所得181638.9元；3.处货值金额5倍的罚款，即190122×5=950610元。以上罚没款合计1132248.9元。罚款金额（万元）95.061没收违法所得、没收非法财物的金额（万元）18.16389处罚决定日期2025年11月10日处罚有效期3年处罚机关广东省药品监督管理局处罚机关统一社会信用代码11440000MB2D034421数据来源单位广东省药品监督管理局数据来源单位统一社会信用代码11440000MB2D034421