行政执法案件信息公开表（2025年第6期，总第164期）序号行政处罚决定书文号案件名称违法企业名称或违法自然人名称违法企业组织机构代码证/ 统一社会信用代码法定代表人/负责人姓名主要违法事实行政处罚内容决定机关名称处罚决定日期公示日期备注1渝药监械处罚〔2024〕18号重庆美印医疗器械有限公司未经许可从事第二类医疗器械生产案重庆美印医疗器械有限公司91500107MA60QLL78K王绍平当事人在未取《医疗器械生产许可证》的情况下，生产销售了定制式义齿。    当事人的行为违反了《医疗器械监督管理条例》第三十二条第一款的规定。依据《医疗器械监督管理条例》第八十八条第二项的规定，决定给予行政处罚如下：1.没收违法所得6029元；2.罚款2万元。重庆市药品监督管理局2025.02.082025.02.11相关推荐CIO提供以下相关文库下载、合规服务以及线上培训课程学习。

当事人：天津市亚捷医用卫生材料有限公司主体资格证照名称：《营业执照》统一社会信用代码（注册号）：91120104596141153Y住所（住址）：天津市西青区杨柳镇柳口路98号25-2-401法定代表人（负责人、经营者）：宋东华身份证件号码：******************我局执法人员根据投诉于2024年11月15日对天津市亚捷医用卫生材料有限公司开展现场检查，发现该公司生产销售的医用超声耦合剂标签中的结构组成和适用范围与经备案的相关内容不一致。我局于2024年11月18日对当事人予以立案调查，2025年1月7日对当事人法定代表人宋东华进行询问调查。本案未对当事人实施行政强制措施。经查，当事人于2023年11月30日完成一类医疗器械医用超声耦合剂的产品备案变更，其中产品描述由“由丙二醇、丙三醇、三乙醇胺、卡波姆组成。”变更为“超声诊断或治疗操作中，充填或涂敷于皮肤与探头（或治疗头）辐射面之间，用于透射声波的中介媒质，不具备消毒功能，非无菌产品。”；预期用途由“用于探头与患者之间的超声耦合。（不具备消毒作用）”变更为“改善探头与患者之间的超声耦合效果，用于完好皮肤上。”。当事人生产的医用超声耦合剂产品标签中的结构组成和适用范围仍按上述备案变更前的内容标识，未按备案变更内容进行更改。当事人的行为构成了生产标签不符合规定的医疗器械医用超声耦合剂的要件。上述事实，主要有以下证据证明：1.当事人提供的《营业执照》、《第一类医疗器械生产备案凭证》、《第一类医疗器械备案凭证》、《第一类医疗器械备案信息表》复印件各1份；2.法定代表人身份证复印件1份；3.现场笔录、询问笔录，投诉件照片，生产记录单、出厂检测报告、产品放行单、产品销售记录复印件各1份；4.当事人提供的主动召回信息发布，《医疗器械召回事件报告表》，《召回计划实施情况报告表》各1份；5.当事人提供的整改报告等证据材料。我局于2025年1月26日向当事人送达行政处罚告知书，当事人在法定期限内未提出陈述、申辩意见。本局认为，当事人生产标签不符合规定的医疗器械医用超声耦合剂的行为，违反了《医疗器械说明书和标签管理规定》第四条第二款“医疗器械说明书和标签的内容应当与经注册或者备案的相关内容一致。”和《医疗器械监督管理条例》第三十九条第一款“医疗器械应当有说明书、标签。说明书、标签的内容应当与经注册或者备案的相关内容一致，确保真实、准确。”的规定。鉴于当事人在本案调查中能够积极配合，主动提供记录等相关证据，积极改正违法行为，并成功召回生产的涉案产品。根据《中华人民共和国行政处罚法》第三十二条“当事人有下列情形之一，应当从轻或者减轻行政处罚：（一）主动消除或者减轻违法行为危害后果的；”和《药品监督管理行政处罚裁量适用规则》第十一条：“当事人有下列情形之一的，可以从轻或者减轻行政处罚：……（二）积极配合药品监督管理部门调查并主动提供证据材料的；……（四）违法行为情节轻微，社会危害后果较小的；……”的规定，对当事人从轻处罚。依据《医疗器械监督管理条例》第八十八条第（二）项“有下列情形之一的，由负责药品监督管理的部门责令改正，处1万元以上5万元以下罚款；拒不改正的，处5万元以上10万元以下罚款；情节严重的，责令停产停业，直至由原发证部门吊销医疗器械生产许可证、医疗器械经营许可证，对违法单位的法定代表人、主要负责人、直接负责的主管人员和其他责任人员，没收违法行为发生期间自本单位所获收入，并处所获收入30%以上2倍以下罚款，5年内禁止其从事医疗器械生产经营活动：（二）生产、经营说明书、标签不符合本条例规定的医疗器械；”、《中华人民共和国行政处罚法》第三十二条第（一）项和《药品监督管理行政处罚裁量适用规则》第十一条第（二）项、第（四）项的规定，责令当事人改正违法行为，决定对当事人作出以下行政处罚：处罚款10000元。当事人应于收到本决定书之日起十五日内按照非税收入一般缴款书（缴款通知书）所载明的缴款渠道缴纳罚（没）款，逾期不缴纳罚款的，依据《中华人民共和国行政处罚法》第七十二条第一款第一项的规定，每日按罚款数额的百分之三加处罚款，并将依法申请人民法院强制执行。                              如你（单位）不服本行政处罚决定，可以在收到本行政处罚决定书之日起六十日内向天津市人民政府申请行政复议；也可以在六个月内依法向天津市红桥区人民法院提起行政诉讼。天津市药品监督管理局（印 章）2025年02月10日相关推荐CIO提供以下相关文库下载、合规服务以及线上培训课程学习。

辽宁省药品监督管理局行政处罚结果公示案件名称营口东盛医药连锁有限公司销售假药“四味脾胃舒颗粒”案处罚决定文书号辽药监(稽八)罚〔2025〕1号被处罚企业名称营口东盛医药连锁有限公司统一社会信用代码91210882399386434T法定代表人韩亮主要违法事实当事人销售假药“四味脾胃舒颗粒”，货值金额133.6元，违法所得33.5元。行政处罚种类和依据没收违法所得。依据《中华人民共和国药品管理法》第一百一十六条和《中华人民共和国药品管理法实施条例》第七十五条。处罚结果没收违法所得33.5元。行政处罚履行方式和期限主动履行；当事人已于2025年2月6日履行完毕。作出处罚的日期2025-02-05相关推荐CIO提供以下相关文库下载、合规服务以及线上培训课程学习。

行政处罚决定书文号：沈苏市监处罚﹝2025﹞21号处罚类别：罚款;没收违法所得;没收非法财物处罚决定日期：2025-02-11处罚内容：1、没收连花清瘟胶囊（规格：24粒装，数量：8盒，规格：26粒装，数量：1盒，规格：24粒装，数量：9盒）;替米沙坦片（规格：7片，数量：5盒）；蜜炼川贝枇杷膏，（规格：22克*9袋，数量：1盒，批号：2305040C，数量：2盒，批号：2312070C，数量：1盒）;硝苯地平控释片（规格：7片装，数量：10盒）； 2、没收违法所得10856.7元； 3、罚款50000元。罚款金额(万元)：5违法行为类型：药品违法事实：未从药品上市许可持有人或者具有药品生产、经营资格的企业购进药品案处罚依据：依据《中华人民共和国药品管理法》第一百二十九条之规定处罚机关：苏家屯区市场局处罚机关统一社会信用代码：112101113407985739数据来源单位：沈阳市苏家屯区市场监督管理局数据来源单位统一社会信用代码：112101113407985739相关推荐CIO提供以下相关文库下载、合规服务以及线上培训课程学习。

根据《药品检查管理办法（试行）》《浙江省药品生产流通飞行检查实施办法（试行）》《关于组织开展2024 年药品 GSP 飞行检查工作的通知》相关规定，现将2024年度第三批浙江省药品经营企业GSP飞行检查情况公开如下：序号企业名称经营范围报告审评结论备注1华东医药供应链管理（杭州）有限公司/符合要求2绍兴英特大通医药有限公司经营范围中药材、中成药、中药饮片、化学原料药、化学药制剂、抗生素原料药、抗生素制剂、生化药品、生物制品、第二类精神药品、医疗用毒性药品、蛋白同化制剂、肽类激素符合要求3杭州致民医药连锁有限公司中药饮片、中成药、化学药制剂、抗生素制剂、生化药品、生物制品(以上均不包含冷藏冷冻药品)符合要求4宁波市鸿海医药药材有限公司中药材、中药饮片、中成药、化学药制剂、抗生素制剂、生化药品、生物制品、蛋白同化制剂、肽类激素符合要求5浙江元亨医药有限公司中药饮片、中成药、化学药制剂、化学原料药、抗生素制剂、抗生素原料药、生化药品，(以上均不包含冷藏冷冻药品)符合要求6浙江康恩贝大药房连锁有限公司中药饮片、中成药、化学药制剂、抗生素制剂、生化药品，(以上均不包含冷藏冷冻药品)符合要求7华润丽水医药有限公司中药材、中药饮片、中成药、化学药制剂、抗生素制剂、生化药品、生物制品、蛋白同化制剂、肽类激素符合要求8阿斯利康医药（杭州）有限公司化学药制剂、抗生素制剂、生化药品、生物制品、（以上均不包含冷藏冷冻药品）符合要求9杭州卫康生物医药有限公司生物制品符合要求10浙江德善医药股份有限公司中药材、中药饮片、中成药、化学药制剂、抗生素制剂、生化药品、生物制品，(以上均不包含冷藏冷冻药品)符合要求

Delivery Method:Via Electronic Mail Return Confirmation RequestedReference #:320-25-37Product:DrugsRecipient:Mr. Sudheer KancherlaChief Executive OfficerStrukmyer LLC dba Strukmyer Medical1801 Big Town Blvd. Ste. 100Mesquite,TX75149-1011United StatesIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter320-25-37January 30, 2025Dear Mr. Kancherla:The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Strukmyer LLC dba Strukmyer Medical, FEI 3000205837, at 1801 Big Town Blvd. Ste. 100, Mesquite, TX, from July 8 to August 1, 2024.This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 211).Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).We reviewed your August 22, 2024 response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence.1. Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192).On over 60 occasions, your firm isolated objectionable microorganisms (e.g.,Burkholderia, Pseudomonas, Staphylococcus, Bacillus, andAspergillusspecies) from your(b)(4)water system used as a component to manufacture over-the-counter (OTC) drug products intended for use in wounds and on burns between November 1, 2022 and July 10, 2024. For example, Pseudomonas and Burkholderia were recovered from samples of your(b)(4)water system on August 15 and August 21, 2023, respectively, and water from this system was used to manufacture(b)(4)batches(b)(4)and(b)(4)on August 21, 2023. You failed to adequately investigate and implement corrective actions to determine root causes and prevent recurrence of these contamination incidents. We note that this drug product was previously the subject of a recall in 2020 for microbial contamination withBurkholderia cepacia.In your response, you state that you updated your(b)(4)water monitoring procedures to include specifications for the absence of objectionable organisms. You also state that you conducted an investigation into the implicated(b)(4)lots and incidents ofBurkholderiaandPseudomonasisolates in your water system and concluded there is no product impact because subsequent water samples collected at the time the water was used to manufacture the drug product were tested and results were observed to be within limits. Further, you state that your finished drug products met your microbial specifications.Your response is inadequate. Your investigation did not adequately identify the root cause of the contamination of your(b)(4)water system with objectionable microorganisms and failed to consider the impact to your distributed drug products that were manufactured with(b)(4)water contaminated with objectionable microorganisms. Microbial contamination is not typically uniformly distributed, especially in a deficient system, and thus samples may not be representative of the type or level of contamination that may exist in other individual units of a batch.Inadequate investigations can lead to unidentified root causes, ineffective corrective actions and preventive actions (CAPA), and recurring problems that compromise the ability to manufacture safe and effective drug products. Frequent microbiological excursions suggest that your purified water system may not be in an adequate state of control.In response to this letter, provide:A comprehensive, independent assessment of the design and control of your firm’s manufacturing operations, with a detailed and thorough review of all microbiological hazards.A detailed risk assessment addressing the hazards posed by distributing drug products with potentially objectionable contamination. Specify actions you will take in response to the risk assessment, such as customer notifications and product recalls.Complete investigations into all batches with potential objectionable microbial contamination or an out-of-specification (OOS) microbiological result (whether or not later invalidated). The investigations should detail your findings regarding the root causes of the contamination.Appropriate microbiological batch release specifications (i.e., total counts, identification of bioburden to detect objectionable microbes) for each of your drug products.All chemical and microbial test methods used to analyze each of your drug products.A summary of results from testing retain samples of all drug product batches within expiry. You should test all appropriate quality attributes including, but not limited to, identity and strength of active ingredients and microbiological quality (total counts and identification of bioburden to detect any objectionable microbes) of each batch. If testing yields an OOS result, indicate the corrective actions you will take, including notifying customers and initiating recalls.A comprehensive, independent assessment of your overall system for investigating deviations, discrepancies, complaints, OOS results, and failures. Provide a detailed action plan to remediate this system. Your action plan should include, but not be limited to, significant improvements in investigation competencies, scope determination, root cause evaluation, CAPA effectiveness, quality unit oversight, and written procedures. Address how your firm will ensure all phases of investigations are appropriately conducted.An independent assessment and remediation plan for your CAPA program. Provide a report that evaluates whether the program includes effective root cause analysis, ensures CAPA effectiveness, analyzes investigations trends, improves the CAPA program when needed, implements final quality unit decisions, and is fully supported by executive management.2. Your firm failed to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality. Your firm also failed to validate and establish the reliability of your component supplier’s test analyses at appropriate intervals (21 CFR 211.84(d)(1) and 211.84(d)(2)).You failed to perform adequate incoming testing of each component lot used in the manufacture of your OTC drug products, such as Therabreath Mild Mint Toothpaste intended for use in children. You also relied on your suppliers’ certificate of analysis (COA) without establishing the reliability of your component suppliers’ test analyses at appropriate intervals.GlycerinYou failed to adequately test each shipment of each lot of glycerin for identity, a component at high-risk of diethylene glycol (DEG) or ethylene glycol (EG) contamination. Identity testing for glycerin and certain other high-risk drug components1includes a limit test in the United States Pharmacopeia (USP) to ensure the component meets the relevant safety limits for levels of DEG or EG. Because you did not perform identity testing on each shipment of each lot using the USP identification test that detects these hazardous impurities, you failed to assure the acceptability of these components for use in the manufacture of your drug products.The use of ingredients contaminated with DEG or EG has resulted in various lethal poisoning incidents in humans worldwide. See FDA’s guidance documentTesting of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated Starch Hydrolysate, Sorbitol Solution, and Other High-Risk Drug Components for Diethylene Glycol and Ethylene Glycolto help you meet the CGMP requirements when manufacturing drugs containing ingredients at high-risk for DEG or EG contamination at https://www.fda.gov/media/167974/download.In your response, you state that you would update the specifications for your glycerin component to include identity testing, including DEG and EG testing, at a(b)(4)testing frequency. Additionally, you state that you tested retain sample of one glycerin lot from each(b)(4)since May 2023 to verify the quality of previously manufactured batches. You also committed to performing DEG and EG testing on the first lot of glycerin received each(b)(4)to confirm the reliability of the testing results on the supplier’s COA.Your response is inadequate. CGMP requires that each shipment of each lot of a component undergo appropriate identity testing (which for glycerin, as noted above, includes a limit test for DEG and EG) before use in drug product manufacturing. Your response also did not include an evaluation of the quality of your drug products currently on the U.S market with inadequate component testing.Component testing is fundamental to quality. Without adequate testing, you do not have scientific evidence that your incoming components conform to appropriate specifications before us in the manufacture of drug products.In response to this letter, provide: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 supplier’s COA instead of testing each component lot for strength, quality, and purity, specify how you will robustly establish the reliability of your supplier’s results through initial validation as well as periodic revalidation. In addition, include a commitment to always conduct at least one specific identity test for each incoming component lot. In the case of glycerin, propylene glycol, and certain additional high-risk components we note that this includes the performance of parts A, B, and C of the USP monograph.The chemical quality control specifications you use to test each incoming lot of high-risk drug components to determine acceptability for use in manufacturing.A comprehensive, independent 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.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 all components to evaluate the reliability of the COA from each component manufacturer. Include your standard operating procedure (SOP) that describes this COA validation program.3. Your firm failed to clean, maintain, and, as appropriate for the nature of the drug, sanitize and/or sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements (21 CFR 211.67(a)).You failed to demonstrate your cleaning and disinfection practices are adequate to remove all contaminants from the equipment used to manufacture your topical OTC drug products. For example, your cleaning validation only tested for the absence of Gram-negative bacteria, but you have previously isolated fungi and gram-positive microorganisms from your water system.Inadequate removal of microbial organisms from manufacturing equipment during cleaning can result in contamination of your drug products, which can potentially cause patient harm depending on the organism.In your response, you committed to performing a new cleaning validation based on “worst-case” scenarios, including a toxicological and microbiological risk assessment of all raw materials using in manufacturing.Your response is inadequate in that the test methods appear to be incomplete.In response to this letter, provide:Your total microbial count limits to monitor whether this system is producing water suitable for the intended uses for each of your drug products.A summary of updated SOPs that ensure an appropriate program is in place for verification and validation of cleaning procedures for products, processes, and equipment.4. Your firm failed to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products (21 CFR 211.22(a)).Your quality unit (QU) failed to ensure the chemical and microbial testing methods performed by your contract laboratory for finished drug product release testing and water system monitoring were not adequately validated or verified as appropriate.In your response, you state that you sent drug product and(b)(4)water samples to your contract laboratory to complete method verification for your chemical and microbial tests. You also updated your procedure to require that method validations and verifications be performed on required test methods.Your response is inadequate. It did not provide assurance that the analytical test methods used to test your components and finished drug products are suitable for the intended purpose. Further, you did not provide an evaluation of potential impact to drug products currently on the U.S. market.An adequate QU overseeing all elements of CGMP is necessary to consistently ensure drug product quality. Your firm’s quality systems are inadequate. See FDA’s guidance document Quality Systems Approach to Pharmaceutical CGMP Regulations at https://www.fda.gov/media/71023/download for help in implementing quality systems and risk management approaches.In response to this letter, provide:A comprehensive assessment and remediation plan to ensure your QU is given the authority and resources to effectively function. The assessment should also include, but not be limited to:o A determination of whether procedures used by your firm to ensure you have an adequate contract testing facility are robust and appropriate.o Provisions for QU oversight throughout your laboratory operations to evaluate adherence to appropriate practices.o Oversight and approval of investigations and discharging of all other QU duties to ensure identity, strength, quality, and purity of all products.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 audit of your entire operation for CGMP compliance and evaluate the completion and efficacy of your CAPA before you pursue resolution of your firm’s compliance status with FDA.Your use of a consultant does not relieve your firm’s obligation to comply with CGMP. Your firm’s executive management remains responsible for resolving all deficiencies and systemic flaws to ensure ongoing CGMP compliance.Cosmetics Manufactured for Distribution in the United StatesIn addition, we note that some of the products you manufacture may be regulated as cosmetics, as defined in section 201(i) of the FD&C Act. Any cosmetics you manufacture must comply with applicable statutory and regulatory requirements, including the FD&C Act. A cosmetic is deemed adulterated under section 601(c) of the FD&C Act [21 U.S.C. 361(c)] if it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth or whereby it may have been rendered injurious to health.Some conditions that cause the drug products you manufacture to be adulterated may also cause any cosmetics you manufacture to be adulterated. We note that under section 301(a) of the FD&C Act [21 U.S.C. 331(a)], it is a prohibited act to introduce or deliver for introduction into interstate commerce a cosmetic that is adulterated. Further, your facility may be subject to requirements under the Modernization of Cosmetics Regulations Act of 2022 (MoCRA). Information on MoCRA requirements may be found at https://www.fda.gov/cosmetics/cosmetics-laws-regulations/modernization-cosmetics-regulation-act-2022-mocra.ConclusionThe violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations.Correct any violations promptly. Failure to promptly and adequately address this matter may result in regulatory or legal action without further notice including, without limitation, seizure and injunction. Unresolved violations may also prevent other Federal agencies from awarding contracts.Failure to address violations may also cause FDA to withhold issuance of Export Certificates. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to address any violations.This letter notifies you of our findings and provides you an opportunity to address the above deficiencies. After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any violations and to prevent their recurrence. In response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion.Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 3000205837 and ATTN: Philip Kreiter.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and Research___________________1Components with higher risk of DEG or EG contamination compared to other drug components.

Delivery Method:Via Electronic Mail Return Confirmation RequestedReference #:320-25-38Product:DrugsRecipient:Ms. Hongwei XuGeneral ManagerWuhu Nuowei Chemistry Co., Ltd.Chuangxin Road, Economic Development ZoneJiujiang QuWuhu ShiAnhui Sheng,241000ChinaIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter320-25-38February 4, 2025Dear Ms. Xu:The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Wuhu Nuowei Chemistry Co., Ltd., FEI 3014438694, at Xuancheng 323 Provincial Road, Pang, Jingde, Xuancheng, from September 2 to 6, 2024.This warning letter summarizes significant deviations from Current Good Manufacturing Practice (CGMP) for active pharmaceutical ingredients (APIs).Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your APIs 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).Additionally, your drug(b)(4)is adulterated under section 501(b) of the FD&C Act, 21 U.S.C. 351(b), for failure to conform to compendial standards for strength, quality, or purity.We reviewed your September 24, 2024 response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence.During our inspection, our investigators observed specific deviations including, but not limited to, the following.1. Failure to ensure that all specifications and test procedures are scientifically sound and appropriate to ensure that your API conform to established standards of quality and purity.You manufacture(b)(4)API that was imported into the United States and supplied to(b)(4). This drug is commonly used(b)(4). You failed to establish that your test methods for testing(b)(4)are scientifically sound, and that your specifications for(b)(4)are appropriate.Your test method for impurities analysis for(b)(4)is based on methods and specifications in the Chinese Pharmacopeia. However, you failed to establish that these test methods are equivalent to or better than the current United States Pharmacopeia (USP) compendial methods.You also failed to establish appropriate impurity specifications for(b)(4). Specifically, your specification limits for any single impurity ((b)(4)%) and for total impurities ((b)(4)%) exceed the USP specification limits of(b)(4)% and(b)(4)%, respectively. We note that a shipment to the United States of a(b)(4)lot, manufactured at your facility, Lot(b)(4), exceeded the USP monograph specification for any single impurity. Beyond a deviation from CGMP, this also causes your drug to be adulterated within the meaning of section 501(b) of the FD&C Act, 21 U.S.C. 351(b), in that its strength, quality, or purity falls below the standards set forth in an official compendium recognized in the FD&C Act. Further, your release testing did not include the related compound(b)(4)and(b)(4), as required by the USP.In your response, you provided an updated method verification report and supporting data for the impurity testing of(b)(4). Your response is inadequate because it did not provide any information to demonstrate that your method is equivalent to or better than the USP compendial method. Your response also did not characterize the impurity profile of(b)(4)manufactured at your facility to demonstrate that your API does not pose a potential safety risk to patients.In response to this letter, provide:Your commitment to using current USP compendial methods until any alternative methods have been demonstrated to be equivalent or better than the USP methods.A comprehensive study that determines whether your test methods for your APIs are equivalent to, or better than, the USP method, if you are not using current USP compendial methods. Include all findings and deviations encountered in assessing whether your alternative method is equivalent or superior to the USP compendial method. For FDA’s current thinking regarding analytical test method validation, seeAnalytical Procedures and Methods Validation for Drugs and Biologicsathttps://www.fda.gov/media/87801/download.Updated test results using a validated test method (e.g., USP method) of all reserve samples for all APIs released to the U.S. market within expiry to ensure that your APIs conform to appropriate standards of identity, strength, quality, and purity.Your action plan to address any product quality or patient safety risks for your APIs in U.S. distribution, including potential customer notifications, recalls, or market withdrawals.Your procedure for documenting and investigating any deviations from laboratory control procedures.2. Failure of your quality unit to exercise its responsibility to ensure the API manufactured at your facility is in compliance with CGMP.You lack adequate quality unit (QU) oversight for the manufacture of your API. Your QU failed to ensure that there was adequate stability data to support retest or expiration dates of API manufactured at your facility.You have inadequate stability data to support the(b)(4)retest date for(b)(4). While you provided stability data tables for(b)(4)lots(b)(4)and(b)(4), you were unable to provide any records of raw data pertaining to these batches.In your response, you provided the stability test data for(b)(4)lot(b)(4)that was shipped to the United States. Your response is inadequate. You did not provide the analytical testing data for lots(b)(4)and(b)(4)that was used to support your(b)(4)retest date, nor any other data to support your retest dates.In response to this letter, provide:A comprehensive, independent assessment and corrective action and preventive plan to ensure the adequacy of your stability program. Your remediated program should include, but not be limited to:o Stability-indicating methods.o Stability studies for each API in its marketed container-closure system before distribution is permitted.o An ongoing program in which representative batches of each product are added each year to the program to determine if the shelf-life claim remains valid.o Detailed definition of the specific attributes to be tested at each station (timepoint).All procedures that describe these and other elements of your remediated stability program.3. Failure to establish adequate written procedures for cleaning equipment and its release for use in manufacture of API.Your cleaning validation for your shared manufacturing equipment for(b)(4)APIs is inadequate.You provided a protocol for cleaning the(b)(4)tank used to manufacture(b)(4), which does not include acceptance criteria for carryover residues. Instead, you relied on visual inspection to determine cleanliness of your equipment and could not provide any analytical or microbiological data to support the efficacy of your cleaning procedures.In your response, you provided an updated cleaning protocol and report for your(b)(4)tank with supporting microbiological data. Your response is inadequate because you did not consider performing analytical testing of potential carryover residues to demonstrate that your cleaning procedure is effective. You also did not provide cleaning procedures for the other equipment used in the manufacture of your APIs.In response to this letter, provide:Appropriate improvements to your cleaning validation program, with special emphasis on incorporating conditions identified as worst case in your drug manufacturing operation. This should include, but not be limited to, identification and evaluation of all worst-case:o Drugs with higher toxicitieso Drugs with higher drug potencieso Drugs of lower solubility in their cleaning solventso Drugs with characteristics that make them difficult to cleano Swabbing locations for areas that are most difficult to cleano Maximum hold times before cleaningIn addition, describe the steps that must be taken in your change management system before introduction of new manufacturing equipment or a new product.A summary of updated standard operating procedures that ensure an appropriate program is in place for verification and validation of cleaning procedures for products, processes, and equipment.A risk evaluation of potential cross-contamination due to inadequate cleaning for APIs within expiry in distribution in the United States.Ineffective Quality SystemSignificant findings in this letter demonstrate that your firm does not operate an effective quality system in accord with CGMP. In addition to the lack of effective management oversight of your production and laboratory operations, we found your QU is not enabled to exercise proper authority and/or has insufficiently implemented its responsibilities. Executive management should immediately and comprehensively assess your company’s global manufacturing operations to ensure that your systems, processes, and products conform to FDA requirements.Imported Drug Labeled for “R&D only”You indicated that you do not distribute your products to the United States, and that one of your customers,(b)(4), ships your products to the United States. Prior to distributing to(b)(4), you label the(b)(4)with labels provided to you by(b)(4)that state, in English, “For R&D only. Not for commercial.” We note, however, the quantity of API (recently as much as(b)(4)in one shipment) shipped into the United States is inconsistent with quantities typically used for research and development.Drug Production CeasedWe acknowledge your commitment to cease production of drugs for the U.S. market and that you deregistered your facility as a drug manufacturer. In response to this letter, clarify whether you intend to resume manufacturing drugs for the U.S. market at this facility in the future and whether you intend to notify your customers that your drugs are not intended for the U.S. market.If you plan to resume any manufacturing operations regulated under the FD&C Act, notify this office before resuming your drug manufacturing operations. If your firm intends to resume manufacturing drugs for the U.S. market, you should engage a consultant qualified to evaluate your operations 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.FDA considers the expectations outlined in ICH Q7 when determining whether API are manufactured in conformance with CGMP. See FDA’s guidance documentQ7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredientsfor guidance regarding CGMP for the manufacture of API at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-q7a-good-manufacturing-practice-guidance-active-pharmaceutical-ingredients.ConclusionThe deviations cited in this letter are not intended to be an all-inclusive list of deviations that exist at your facility. You are responsible for investigating and determining the causes of any deviations and for preventing their recurrence or the occurrence of other deviations.FDA placed products offered for import into the United States from your firm on Import Alert 66-40 on January 24, 2025.Correct any deviations promptly. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any deviations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to any deviations.Failure to address any deviations may also result in the FDA continuing to refuse admission of articles manufactured at Wuhu Nuowei Chemistry Co., Ltd., at Jiujiang, Chuangxin Road, Economic Development Zone, Wuhu, 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 deviations 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 3014438694 and ATTN: Christopher Keating.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and Research

Delivery Method:VIA Electronic MailReference #:320-25-40Product:DrugsRecipient:Ren ZhongjuChengdu Innovation Pharmaceutical Co., Ltd.No.123, 1st Floor, No 91 Zhongheng StreetJinniu QuChengdu ShiSichuan Sheng,610036ChinaIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter320-25-40February 5, 2025Dear Ren Zhongju:Your facility was registered with the United States Food and Drug Administration (FDA) as a manufacturer of active pharmaceutical ingredients (APIs). FDA has reviewed the records you submitted in response to our April 29, 2024 request 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, Chengdu Innovation Pharmaceutical Co., Ltd., FEI 3027222600, No.123, 1st Floor, No 91 Zhongheng Street, Jinniu District, Chengdu, Sichuan, China.This warning letter summarizes significant deviations from Current Good Manufacturing Practice (CGMP) for API.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 APIs 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 review of records and other information provided pursuant to section 704(a)(4) of the FD&C Act, significant deviations were observed including, but not limited to, the following:704(a)(4) Request for Records and Related CGMP Deviations1. Failure to test the identity of each lot of incoming production material.You manufacture APIs that were distributed to(b)(4)in the United States. Based on the records and information you provided, you have not demonstrated that you are adequately testing each shipment of each lot of incoming materials. Specifically in response to our request, you state that you do not perform identity testing on each shipment of each lot of incoming material before they are released for use in drug manufacturing.Without adequate testing, you do not have scientific evidence that incoming materials conform to appropriate specifications prior to use in the manufacture of your drugs. As a manufacturer, you have a responsibility to sample, test, and examine incoming materials before use in production to assure adequate quality.In response to this letter, provide:A description of how you will test each incoming material lot for conformity with all appropriate specifications for identity. If you intend to accept any results from your supplier’s certificate of analysis (COA) instead of testing each incoming material lot for other tests, specify how you will ensure that you have adequate evidence to establish that the supplier consistently provides material meeting specifications. In addition, include a commitment to always conduct at least one specific identity test for each incoming material lot.A comprehensive, independent review of your material system to determine whether all suppliers of incoming materials 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 materials.A summary of your program for qualifying and overseeing contract facilities that test the drugs you manufacture.A summary of results obtained from testing all incoming materials to evaluate the reliability of the COA from each incoming materials manufacturer. Include your standard operating procedure that describes this COA validation program.2. Failure of your quality unit to establish a system to release or reject raw materials, intermediates, packaging, and labeling materials.The records and information you provided demonstrate that your quality unit (QU) did not effectively exercise its responsibilities to oversee the quality of your drug manufacturing operations. Specifically, your QU did not establish an appropriate system to approve or reject incoming materials.Your QU is responsible for fully exercising its authority and responsibilities.An adequate QU overseeing all elements of CGMP is necessary to consistently ensure drug quality. FDA considers the expectations outlined in ICH Q7 when determining whether API are manufactured in conformance with CGMP, including sections on quality oversight. See FDA’s guidance documentQ7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredientsfor guidance regarding CGMP for the manufacture of API athttps://www.fda.gov/media/71518/download.In response to this letter, provide:A comprehensive assessment and remediation plan to ensure your QU is given the authority and resources to effectively function. The assessment should also include, but not be limited to:o A determination of whether procedures used by your firm are robust and appropriate.o Provisions for QU oversight throughout your operations to evaluate adherence to appropriate practices.o A complete and final review of each batch and its related information before the QU disposition decision.o Oversight and approval of investigations and discharging of all other QU duties to ensure identity, quality, and purity of all products.CGMP Consultant RecommendedBased upon the nature of the deviations we identified at your firm, you should engage a consultant qualified to evaluate your operations and to assist your firm in meeting CGMP requirements. The qualified consultant should also perform a comprehensive six-system audit of your entire operation for CGMP compliance and evaluate the completion and efficacy of your corrective actions and preventive actions.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 deviations cited in this letter are not intended to be an all-inclusive list of deviations that exist at your facility. You are responsible for investigating and determining the causes of any deviations and for preventing their recurrence or the occurrence of other deviations.FDA placed products offered for import into the United States from your firm on Import Alert 66-40 on January 17, 2025.Correct any deviations promptly. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any deviations are completely addressed and we confirm your compliance with CGMP. We may inspect to verify that you have completed corrective actions to any deviations.Failure to address deviations may also cause FDA to withhold issuance of Export Certificates. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any deviations are completely addressed and we confirm your compliance with CGMP. We may inspect your facility to verify that you have completed corrective actions to address any deviations.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 30 working days. Specify what you have done to address any deviations 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 3027222600 and ATTN: William Yang.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and Research

福建省药品监督管理局行政处罚信息公开表序号行政处罚决定书文号案件名称违法企业名称或违法自然人姓名违法企业社会信用代码法定代表人姓名主要违法事实行政处罚的种类和依据行政处罚的履行方式和期限做出处罚的机关名称和日期备注1闽药监厦稽办处罚〔2025〕001号涉嫌生产不符合经注册产品技术要求的医用防护口罩漳州元然医疗器械有限公司91350681MA33K2RB11 陈**根据福建省食品药品质量检验研究院《检验报告》（编号：2024YC0358）和海南省检验检测研究院《检验报告》(编号：QF20240001、复检)，漳州元然生产的医用防护口罩（规格型号：无菌型折叠耳挂式、中号：15.5cm*10.5cm、批号：2022/11/01）经检验和复检均不合格，具体不合格项目为过滤效率。经查，漳州元然于2022年11月1日至20日期间，生产了30000片医用防护口罩，均已销售，涉案批次产品价格为3.2元/片,召回数量为零。综上，上述涉案批次产品总货值金额为96000元，违法所得为96000元。当事人上述行为违反了《医疗器械监督管理条例》第三十五条第一款的规定，构成生产不符合经注册产品技术要求的医用防护口罩的违法行为。依据《中华人民共和国行政处罚法》第二十八条第二款、《医疗器械监督管理条例》第八十六条第一项、《福建省药品监管行政处罚裁量适用细则》第十一条第一款第二项、第七项的规定，决定给予漳州元然如下处理： 一、责令改正；二、没收违法所得96000元整（玖万陆仟元整）；三、罚款480000元整（肆拾捌万元整）；上述罚没款合计576000元整（伍拾柒万陆仟元整）。当事人应自接到本行政处罚决定之日起15日内缴纳上述罚没款。当事人根据福建省药品监督管理局厦门药品稽查办开具的行政处罚缴款通知书，自行选择缴款方式。逾期不缴纳罚款的，依据《中华人民共和国行政处罚法》第七十二条第一款的规定，我办将每日按罚款数额的百分之三加处罚款，并依法申请人民法院强制执行。福建省药品监督管理局，2025年1月21日。相关推荐CIO提供以下相关文库下载、合规服务以及线上培训课程学习。

行政相对人名称齐齐哈尔药小帮大药房有限公司行政相对人代码(统一社会信用代码)91230202MAD3H3LX8H法定代表人孙佳男行政处罚决定书文号齐龙市监处罚〔2025〕6号违法行为类型生产、销售假药行为违法事实2024年12月6日，我局接到“齐齐哈尔市市场监督管理局”下发的关于对《关于处罚依据《中华人民共和国药品管理法(2019修订)》 / 第一百一十六条生产、销售假药的，没收违法生产、销售的药品和违法所得，责令停产停业整顿，吊销药品批准证明文件，并处违法生产、销售的药品货值金额十五倍以上三十倍以下的罚款；货值金额不足十万元的，按十万元计算；情节严重的，吊销药品生产许可证、药品经营许可证或者医疗机构制剂许可证，十年内不受理其相应申请；药品上市许可持有人为境外企业的，十年内禁止其药品进口。;《中华人民共和国药品管理法实施条例》 / 第七十五条药品经营企业、医疗机构未违反《药品管理法》和本条例的有关规定，并有充分证据证明其不知道所销售或者使用的药品是假药、劣药的，应当没收其销售或者使用的假药、劣药和违法所得；但是，可以免除其他行政处罚。处罚类别没收违法所得处罚内容依据《中华人民共和国药品管理法》第一百一十六条“生产、销售假药的，没收违法生产、销售的药品和违法所得，责令停产停业整顿，吊销药品批准证明文件，并处违法生产、销售的药品货值金额十五倍以上三十倍以下的罚款;货值金额不足十万元的，按十万元计算;情节严重的，吊销药品生产许可证、药品经营许可证或者医疗机构制剂许可证，十年内不受理其相应申请;药品上市许可持有人为境外企业的，十年内禁止其药品进口。”之规定和《中华人民共和国药品管理法实施条例》第七十五条“药品经营企业、医疗机构未违反《药品管理法》和本条例的有关规定，并有充分证据证明其不知道所销售或者使用的药品是假药、劣药的，应当没收其销售或者使用的假药、劣药和违法所得;但是，可以免除其他行政处罚。”的规定，现责令当事人改正上述违法行为，积极协助生产企业履行召回义务，并决定没收违法所得32.5元。没收违法所得没收非法财物的金额（万元）0.00325处罚决定日期2025-02-10处罚有效期2027-02-10公示截止期2028-02-10处罚机关齐齐哈尔市龙沙区市场监督管理局相关推荐CIO提供以下相关文库下载、合规服务以及线上培训课程学习。