行政相对人名称四川同创康能药业有限公司行政相对人类别法人组织行政相对人代码（统一社会信用代码）91510121396145774N法定代表人赵胜兰行政处罚决定书文号川药监罚决〔2024〕1025号违法行为类型生产、销售劣药款冬花（批号：230301）违法事实生产销售劣药款冬花（批号：230301），货值金额77770元，实际违法所得65880元处罚依据《中华人民共和国药品管理法》第一百一十七条第一款，《川渝药品医疗器械化妆品行政处罚裁量权适用规则》第十一条第二项、第八项、第十一项处罚内容罚款100000元，没收违法所得65880元。罚没款合计165880元。处罚决定日期2025年1月2日处罚机关四川省药品监督管理局处罚机关统一社会信用代码11510000MB1808933T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：东莞市壹药坊医药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：统一社会信用代码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91441900MA54PWRK9044***********05法人代表姓名：聂旺登法定代表人证件类型：法定代表人证件号码：行政处罚决定书文号：东市监处罚〔2025〕Z320150106BO1违法行为类型：《中华人民共和国药品管理法》第九十八条第一款“禁止生产（包括配制，下同）、销售、使用假药、劣药。”违法事实：经查明，当事人2024年1月11日通过药帮忙APP（手机软件）从辽宁中联医药有限公司购入“四味脾胃舒颗粒”（生产厂家：广西天天乐药业股份有限公司；批准文号：国药准字Z0026557；批号:230780；订单编号：YBM20240111***********9）5盒，提供了购进上述药品时索取的药品销售随货同行单、检验报告单、供货商资质证明文件等资料复印件。依据辽宁省药品监督管理局《关于通报函四味脾胃舒颗粒假药案件线索的函》（辽药监稽函[2024]01132号）、《辽宁省药品监督管理局关于对沃德万方（辽宁）医药物流有限公司经营的“四味脾胃舒颗粒”认定意见的函》，当事人购进的上述“四味脾胃舒颗粒”（生产厂家：广西天天乐药业股份有限公司；批准文号：国药准字Z0026557；批号:230780）符合“以他种药品冒充此种药品”情形，经认定，为假药。当事人在公司（药店）店铺门口张贴公告，进行召回，未能召回到上述药品，亦未收到消费者反馈吃药后产生不良应的信息。当事人购进上述药品5盒，购进价为46.25元/盒，销售了5盒，销售价为68元/盒，取得销售收入为340元，取得售出价格与购入价格的差价共108.75元。处罚依据：《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。”。《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：没收违法所得人民币壹佰零捌元柒角伍分（108.75）。罚款金额（万元）：没收违法所得、 没收非法财物的金额：0.010875暂扣或吊销证照名称及编号：处罚决定日期：2025-01-08公示截止期：2028-01-08处罚机关：东莞市市场监督管理局数据来源单位：东莞市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。

行政相对人名称江苏辰宇医疗器械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91320903683527775E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徐学海法定代表人证件类型身份证法定代表人证件号码3****************8证件类型证件号码行政处罚决定书文号苏（盐检）药监械处字〔2024〕5号违法行为类型违反了《医疗器械监督管理条例》第三十五条第一款的规定违法事实违反了《医疗器械监督管理条例》第三十五条第一款的规定，依据《医疗器械监督管理条例》第八十六条第一项的规定，应予处罚。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;没收非法财物处罚内容1.没收库存的玻璃体温计9850支；2.处以货值金额33000元的9.6倍罚款316800元。罚款金额（万元）31.68没收违法所得没收非法财物的金额（万元）3.2505暂扣或吊销证照名称及编号处罚决定日期2025/01/08处罚有效期2025/07/08公示截止期2026/01/08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。

行政相对人名称四川挽卿丝日化有限公司行政相对人类别法人组织行政相对人统一社会信用代码91510521MA66RB6N7P法定代表人施正群行政处罚决定书文号川药监处罚〔2024〕3005号违法行为类型《化妆品监督管理条例》第六条第二款违法事实生产经营不符合技术规范的化妆品剪名居留香洗发露（批号：20231013X）。处罚依据《化妆品监督管理条例》第六十条第（二）项和《中华人民共和国行政处罚法》第六条、第二十八条、第三十二条第（一）项。处罚类别没收非法财物、没收违法所得，罚款处罚内容1.没收涉案产品268瓶；2.没收违法所得2555.00元；3.处罚款6610.93元。罚款金额（元）6610.93没收违法所得、没收非法财物的金额（元）6610.93处罚决定日期2025年1月2日处罚机关四川省药品监督管理局处罚机关统一社会信用代码11510000MB1808933T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。

序号行政处罚决定书文号违法企业名称或自然人姓名法定代表人姓名违法企业组织机构代码违法行为类型主要违法事实行政处罚的内容行政处罚的依据履行方式和期限作出处罚决定的行政机关和日期1鄂药监武妆处罚〔2024〕3号武汉润禾生物医药有限公司郑和平91420112751826997R生产不符合技术规范的化妆品经检验，当事人生产的化妆品不符合《化妆品安全技术规范（2015年版）》要求，违反了《化妆品监督管理条例》第二十五条第三款的规定。1.没收违法产品；2.没收违法所得；3.罚款。《化妆品监督管理条例》第六十条第（二）项的规定主动履行，当事人收到行政处罚决定书之日起十五日内湖北省药品监督管理局2025年01月08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。

Delivery Method:Via EmailReference #:320-25-23Product:DrugsRecipient:Ms. Aditi Kare PanandikarManaging DirectorIndoco Remedies LimitedIndoco House, 166, C.S.T RoadKalina Santacruz (E)Mumbai400098IndiaIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter320-25-23December 16, 2024Dear Ms. Panandikar:The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Indoco Remedies Limited, FEI 3005124189, at L 32 33 - 34 I D C Verna Industrial Road, Vasco Da Gama, Goa, India, from July 16 to 26, 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 15, 2024 response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence.During our inspection, our investigators observed specific violations including, but not limited to, the following.1. Your firm failed to record and justify any deviations from required laboratory control mechanisms (21 CFR 211.160(a)).You lacked adequate controls to assure the reliability of microbiological testing results. For example:A. Numerous non-viable dark particles were observed in(b)(4)plates used for microbiological analyses in your laboratory.B. Non-viable dark particles were observed on filter(b)(4)used for(b)(4)microbiological testing.C. Media plates prepared in-house did not consistently possess smooth surfaces needed to ensure maximum contact of test articles to facilitate the growth of any microbiological organisms present.D. Analysts did not consistently ensure filter(b)(4)on media plates during microbiological testing needed to ensure maximum contact of filter(b)(4)to facilitate the growth of any microbiological organisms present.In your response, you indicate you discontinued use of, and discarded, the implicated filter(b)(4)lot associated with the observed particulate matter and are attempting to identify an alternate vendor. You also performed a retrospective review of(b)(4)testing data, and you do not identify any similar instances of air bubbles being observed during testing. You conclude any incidence of failing to ensure filter(b)(4)on media plates during testing are “rare” and do not impact product quality.Your response is inadequate. You do not holistically assess microbiological laboratory conditions and practices and their impact on the reliability of microbiological test results. Your retrospective review protocol to identify instances of(b)(4)filter(b)(4)during testing is insufficient as it relies on documentation of events that were not being recorded by your analysts. Additionally, the conclusion of the retrospective review stating there was no impact on product quality lacks scientific justification, in that contact between the filter(b)(4)and the media is essential for the growth and identification of any microbiological organisms on the filter(b)(4).In response to this letter, provide:A comprehensive, independent assessment of your laboratory practices, procedures, methods, equipment, documentation, and analyst competencies. Based on this review, provide a detailed plan to remediate and evaluate the effectiveness of your laboratory system.A retrospective, independent review of all microbiological test data for products currently in the U.S. market and within expiry as of the date of this letter to assess the impact of the observed laboratory conditions and practices on the reliability of the microbiological test data. The review should include testing performed in support of qualification and validation activities currently relied upon to support the manufacture of drug products for the U.S. market.A comprehensive, independent review of your material system to determine whether all suppliers of equipment and test supplies 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 equipment and test supplies.2. Your firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes (21 CFR 211.113(b)).Our review found deficiencies in video recordings of airflow (smoke) studies executed in the ISO 5 areas including on Line(b)(4)at the empty vial(b)(4)and the nozzle(b)(4). Specifically, the presence of excessive smoke prevented visualization of airflows. The inadequate visualization of airflow is a repeated from the 2023 inspection of your facility.In your response, you commit to providing additional training to personnel responsible for the execution of airflow studies and to conduct new studies.Your response is inadequate. Your previous actions taken to prevent recurrence were inadequate. You do not commit to reassessing your training program or the failure of previously implemented corrective action and preventive action (CAPA) to remediate the airflow studies. In response to this letter, provide:An independent assessment of the training provided to personnel responsible for the execution of airflow study protocols.An independent assessment of the CAPA effectiveness in response to previous adverse findings associated with your conduct of airflow studies. The assessment should include the determination of root cause(s), CAPA, and a description of how the CAPA effectiveness will be determined.A revised Line(b)(4)airflow study protocol, completed protocol report, the airflow study videos, and an independent assessment of the aforementioned protocol, complete protocol report, and airflow study videos.3. Your firm failed to establish an adequate system for maintaining equipment used to control the aseptic conditions (21 CFR 211.42(c)(10)(vi)).Our review found unsuitable conditions in ISO 5 areas where aseptic processing is conducted. For example:A. Rough metal surfaces and an incomplete(b)(4)were observed on the Line(b)(4)Restricted Access Barrier System (RABS) framework in the area above the stopper loading chute.B.(b)(4)or(b)(4)were observed protruding through the interior of RABS(b)(4)on the Line(b)(4)RABS in the area above the stopper loading chute.C.(b)(4)conduit was present with exposed wires and not properly secured to the adjoining surface in the Line(b)(4)filtration area.You previously remediated the Line(b)(4)RABS in response to the unsuitable physical condition of Line(b)(4)RABS(b)(4)documented in the 2023 inspection of this facility. Your remediation activities failed to wholistically address the conditions of the Line(b)(4)RABS.In your response, you report Lines(b)(4)were inspected for additional “uneven rough surfaces,” commit to inspecting Lines(b)(4)in the future, and updating procedures to require the inspection of areas for the presence of uneven and rough surfaces. You report an inspection of Lines(b)(4)for areas that are difficult to clean and identified a root cause for the electrical conduit not being properly secured as “improper verification” of the conduit. You also report the conduct of “Awareness Training” of personnel in your Engineering department.Your response is inadequate. You do not:Evaluate the training of personnel responsible for inspection activities.Perform a comprehensive assessment of all lines and equipment therein to ensure appropriate design and suitability of materials of construction and equipment.Comprehensively assess procedures governing equipment design to ensure appropriate user requirements are established.Assess the quality unit’s (QU) role in assuring the suitability of the facility and equipment therein.In response to this letter, provide your CAPA plan to implement routine, vigilant operations management oversight of facilities and equipment. This plan should ensure, among other things, prompt detection of equipment/facilities performance issues, effective execution of repairs, adherence to appropriate preventive maintenance schedules, timely technological upgrades to the equipment/facility infrastructure, and improved systems for ongoing management review. Explain how you will use qualified third-party consultant(s) to assist you in development, execution, and assessment of CAPA effectiveness for these activities.4. 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).Your investigations into product quality defect complaints are not consistently and scientifically supported and rely on flawed analyses to reach conclusions on product quality impact. For example:A. Your investigation into complaints of dispensing tip (nozzle) blockage associated with(b)(4)solution USP(b)(4)% ((b)(4)) and(b)(4)and(b)(4)solution USP,(b)(4)mg/ml and(b)(4)mg/mL ((b)(4)) concluded the tip blockage phenomena was due to improper storage by patients. You stated the ensuing exposure of product solutions to air resulted in the(b)(4)excipient in the formulations forming a film or precipitating and blocking the dispensing tips. Your investigation is deficient for reasons including, but not limited to:1. Neither of the scientific publication sources cited in your investigation support your root cause.2. Your experimental study compared the effect of atmospheric exposure of a freshly prepared solution by your research and development group against samples of innovator product that expired approximately 2.5 years earlier.B. Your investigations into complaints of(b)(4)and(b)(4)drug products missing tips or being received empty by patients were repeatedly determined to have no impact on product quality. This conclusion conflicts with the finished product quality attributes for fill volume.In your response, you report your(b)(4). You also report the revision of your complaint handling procedure and your plan to evaluate the function of equipment used to detect missing container closure system components.Your response is inadequate. You do not provide sound scientific data or other relevant information supporting your conclusion that atmospheric exposure of(b)(4)in these products is solely responsible for the tip blockage complaints. You also did not adequately address empty units being received by patients.In response to this letter, provide:A scientifically sound investigation into the tip blockage issue. The investigation should identify root cause(s), CAPA, and the mechanism(s) for determining CAPA effectiveness.An independent evaluation of your product quality complaint handling procedures and practices including relevant procedures and practices used by contracted third parties that perform complaint handling activities on your behalf. The independent evaluation should include identification of all deficiencies, assignment of appropriate CAPA, and the mechanism(s) for determining CAPA effectiveness.5. Your firm failed to establish an adequate quality unit and the responsibilities and procedures applicable to the quality control unit are not in writing and fully followed (21 CFR 211.22(a) and 211.22(d)).Warning and error messages in the Empower Message Center included in your chromatography data software are not reviewed. For example, during the 20-day period between December 26, 2023, and January 15, 2024, the following error messages were registered in the Empower Message Center:A. Approximately 33 instances of “Injection --- cannot be altered. It belongs to a sample set which is currently being acquired”B. Approximately 60 instances of “User Abort”C. Approximately 18 instances of “Stop Flow key was pressed”The procedures governing chromatography analyses do not require the review of all audit trail data. Your personnel were unaware of the requirement to review the Empower Message Center data in Plant(b)(4)analyses during the inspection. The error and warning messages in the Empower Message Center can be an indicator of problems with equipment and method suitability.In your response, you report revisions to the procedures governing chromatography analyses in Plant(b)(4)and Plant(b)(4)to require the review of data in the Empower Message Center. You also report the conduct of a “comprehensive review” of data in the Empower Message Center in Plant(b)(4)and Plant(b)(4)and corresponding risk assessments. You also indicate you do not review the Empower Message Center as required by your procedure governing chromatography analyses in Plant(b)(4).Your response is inadequate. Your review of data in the Empower Message Center failed to identify unexpected discrepancies including approximately 32 of the 33 instances of “Injection --- cannot be altered. It belongs to a sample set which is currently being acquired” messages generated between December 26, 2023, and January 15, 2024, were associated with the same user. You also did not identify and investigate the relatively high number of “User Abort” messages generated over the same timeframe.In response to this letter, provide an independent, retrospective assessment of Empower Message Center data for the last three years from the initial date of inspection and a report summarizing the findings of the analysis. The analysis should include trending of pertinent data including, but not limited to, specific users, methods, and equipment.Repeat Violations at FacilityIn a previous inspection, dated February 20 to February 28, 2023, FDA cited similar CGMP violations. You proposed specific remediation for these violations in your response. Repeated failures demonstrate that executive management oversight and control over the manufacture of drugs is inadequate.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 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.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 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 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.If you are considering an action that is likely to lead to a disruption in the supply of drugs produced at your facility, FDA requests that you contact CDER’s Drug Shortages Staff immediately, at drugshortages@fda.hhs.gov, so that FDA can work with you on the most effective way to bring your operations into compliance with the law. Contacting the Drug Shortages Staff also allows you to meet any obligations you may have to report discontinuances or interruptions in your drug manufacture under 21 U.S.C. 356C(b). This also allows FDA to consider, as soon as possible, what actions, if any, may be needed to avoid shortages and protect the health of patients who depend on your products.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 refusing admission of articles manufactured at Indoco Remedies Ltd., L 32 33 - 34 I D C Verna Industrial Road, Vasco Da Gama, Goa, India, 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 days1. 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 3005124189 and ATTN: Jason F. Chancey.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and Research_________________1Under program enhancements for the Generic Drug User Fee Amendments (GDUFA) reauthorization for fiscal years (FYs) 2023-2027, also known as the GDUFA III Commitment Letter, your facility may be eligible for a Post-Warning Letter Meeting to obtain preliminary feedback from FDA on the adequacy and completeness of your corrective action plans.

Delivery Method:VIA UPS and Electronic MailReference #:CBER 25-697717Product:BiologicsRecipient:David P. JaniceChief Executive Officer and OwnerXO Biologix, LLC609 Castle Ridge Rd, Suite 400Austin,TX78746United States(b)(6)Issuing Office:Center for Biologics Evaluation and Research (CBER)United StatesWARNING LETTERCBER 25-697717December 12, 2024Dear Mr. Janice:The United States Food and Drug Administration (FDA) inspected your facility located at the above address between January 3, 2024, and January 5, 2024. During the inspection, FDA documented that your company markets and distributes a product derived from amniotic fluid, MaviX™, pursuant to a contract with(b)(4)(hereinafter, “MaviX™” or “your product”).This letter is to advise you that your product is an unapproved new drug in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 355(a). Your introduction or delivery for introduction of your product into interstate commerce is prohibited under section 301(d) of the FD&C Act, 21 U.S.C. § 331(d). Your product is also an unlicensed biological product in violation of section 351(a)(1) of the Public Health Service Act (PHS Act), 42 U.S.C. § 262(a)(1)(A).This Warning Letter also notifies you that your products are adulterated due to significant violations of current good manufacturing practice (CGMP) requirements identified at(b)(4), including violations of section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. § 351(a)(2)(B), and 21 CFR parts 210 and 211 (See Warning Letter number CBER 25-679023). Your firm is responsible for ensuring that all phases of the production of your product comply with CGMP requirements regardless of who manufactures, processes, packs, or holds it. Because the methods, facilities, or controls for manufacturing, processing, packing, or holding drugs do not conform to CGMP, your product is adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. § 351(a)(2)(B). Furthermore, MaviX™ is also misbranded under sections 502(a) of the FD&C Act, 21 U.S.C. § 352(a).Your introduction or delivery for introduction of MaviX™, an adulterated and misbranded drug, into interstate commerce is a prohibited act under section 301(a) of the FD&C Act, 21 U.S.C. § 331(a).Unapproved New Drug and Unlicensed Biological Product ViolationsBased on information and records gathered prior to, during, and after the inspection and other information available to FDA, including your website (https://xobiologix.co/), your product is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease or conditions in humans and/or is intended to affect the structure or function of the body. For example, MaviX™ promotional material obtained during your inspection states the following: “Patient Benefits: Helps reduce pain, inflammation, and regenerate tissue”. Further, your website indicates that “MaviX™ is a heterogeneous, complex mixture of cell and tissue building blocks, which play a key role in repair and regeneration” and describes MaviX™ as “Anti-Inflammatory” and “Anti-Fibrotic.” Your product is therefore a drug as defined in section 201(g)(1) of the FD&C Act, 21 U.S.C. § 321(g)(1). Additionally, your product is a biological product as defined in section 351(i) of the PHS Act, 42 U.S.C. § 262(i).1Subject to certain exceptions not applicable here, to lawfully introduce or deliver for introduction into interstate commerce a drug that is a biological product, a valid biologics license application (BLA) must be in effect under section 351(a)(1) of the PHS Act, 42 U.S.C. § 262(a)(1). Such licenses are issued only after showing that the products are safe, pure, and potent. Your product is not the subject of an approved BLA.Current Good Manufacturing Practice ViolationsRefer to Warning Letter number CBER 25-679023 for discussion of CGMP violations.Misbranding ViolationYour product is also misbranded under section 502(a) of the FD&C Act, 21 U.S.C. § 352(a), because your labeling is false or misleading. Specifically, the instructions for use (IFU) for your product indicates that “the tissue is processed and may be cut into predetermined size patches using sterile cutting tools.” This description implies that your product is provided as sheets when it is actually a liquid solution. Further, your certificate of analysis for your product states that the expiry period is five (5) years, while your IFU states that your product has a “3-year shelf life.” Neither of these statements about the stability of your product are supported with stability data. These false or misleading representations about your product on your labeling cause this product to be misbranded under section 502(a) of the FD&C Act, 21 U.S.C. § 352(a).ConclusionNeither this letter nor the observations noted on the Form FDA-483, List of Inspectional Observations that was issued to(b)(4), are intended to be an all-inclusive list of deficiencies that may exist. It is your responsibility to ensure full compliance with the FD&C Act, PHS Act, and all applicable regulations.This letter notifies you of our findings and provides you an opportunity to address them. Failure to adequately address these matters may result in regulatory action without further notice. Such actions may include seizure and/or injunction.We request that you respond in writing within fifteen (15) working days from your receipt of this letter, outlining the specific steps you have taken or plan to take to address any violations and prevent their recurrence. Include any documentation necessary to show that the matters have been addressed. If you cannot address these matters within fifteen (15) working days, please explain the reason for your delay and the timeframe for completion. If you do not believe your products are in violation of the FD&C Act, PHS Act, or applicable regulations, include your reasoning and any supporting information for our consideration.Send your electronic response to CBERDCMRecommendations@fda.hhs.gov. If you have questions regarding this letter, contact the Division of Case Management, CBER at (240) 402-9156.Sincerely,/S/Melissa J. MendozaDirectorOffice of Compliance and Biologics QualityCenter for Biologics Evaluation and ResearchCc:(b)(4)_________________1FDA does not consider MaviX™, an amniotic fluid-based product, to be a human cell, tissue, or cellular or tissue-based product (HCT/P). HCT/Ps, as defined in 21 CFR 1271.3(d), do not include secreted or extracted human products. Accordingly, secreted bodily fluids, such as amniotic fluid, are generally not considered HCT/Ps subject to regulation under 21 CFR part 1271.

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组织机构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桂药监化稽罚〔2024〕2号上市销售未备案的普通化妆品案广西梧州市藤县亮友医药卫生用品有限公司914504223403516912黄柏顺当事人上市销售未备案的普通化妆品的行为，违反了《化妆品监督管理条例》第十七条“国产普通化妆品应当在上市销售前向备案人所在地省、自治区、直辖市人民政府药品监督管理部门备案”的规定。依据《中华人民共和国行政处罚法》第二十八条、《化妆品监督管理条例》第六十一条第一款第（一）项的规定，我局决定责令当事人改正上述违法行为，并给予以下行政处罚：1.没收召回未备案的化妆品128瓶及专门用于违法生产经营的包装材料11套；2.没收违法所得3072.00元；3.并处3万元罚款。以上罚没款合计33072.00元。广西壮族自治区药品监督管理局  2024年12月31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。

当事人：天津市海诺德工贸有限公司主体资格证照名称：营业执照统一社会信用代码：91120103735448025C住所（住址）：天津市津南区长青科工贸园区北京街56号法定代表人（负责人、经营者）：康健身份证件号码：***2024年9月10日执法人员对天津市海诺德工贸有限公司进行监督检查，发现在生产车间二层工人使用吹风机将标识有“Sodium bicarbonate cartridge for hemodialysis”的联机透析B干粉的标签（装量720克，Mfg（生产日期）20240117，Lot（产品批号）24011701）的标签揭掉更换成“700g/筒±2%，生产日期20240806，批号24080601”的标签。执法人员现场将更换标签的联机透析B干粉109筒、未贴标签的联机透析B干粉234筒、尚未使用的联机透析B干粉标签81张予以扣押并下达《实施行政强制措施决定书》（津药监（三办）强制〔2024〕7号）；2024年10月9日执法人员向当事人下达了《延长行政强制措施期限决定书》（津药监（三办）延强〔2024〕7号）；2024年11月8日执法人员向当事人下达了《解除行政强制措施决定书》（津药监（三办）解强〔2024〕7号）。经进一步调查，天津市海诺德工贸有限公司因用于出口的联机透析B干粉未能及时售出，故欲将其更换成国内销售的产品标签用于国内销售，案发时还未售出。其擅自将生产日期20240117更改为20240806、产品批号24011701更改为24080601，装量由720克更改为“700克±2%”，更改后的产品无生产记录、检验记录以及放行记录，违背了《医疗器械生产质量管理规范》第五十条“每批（台）产品均应当有生产记录，并满足可追溯的要求。”、第五十九条“每批（台）产品均应当有检验记录，并满足可追溯的要求。检验记录应当包括进货检验、过程检验和成品检验的检验记录、检验报告或者证书等。”及第六十条“企业应当规定产品放行程序、条件和放行批准要求。放行的产品应当附有合格证明。”的规定，造成产品不可追溯，医疗器械质量管理体系未能保持有效运行。上述事实，主要有以下证据证明：1.天津市海诺德工贸有限公司《营业执照》复印件、《医疗器械生产许可证》复印件、联机透析B干粉注册证复印件、企业法定代表人身份证复印件，证明当事人主体资格及产品资质情况；2. 现场检查笔录2份、询问笔录1份，批号为24011701的联机透析B干粉生产记录及检验记录、2024年销售记录、货值金额确认，证明当事人未保持医疗器械质量管理体系有效运行以及更改产品标签、该批次产品货值金额的事实。我局执法人员已于2024年12月23日对当事人送达《行政处罚告知书》，当事人未提出陈述、申辩意见。本局认为，当事人涉嫌未保持医疗器械质量管理体系有效运行的行为违反了《医疗器械监督管理条例》第三十五条第一款：“医疗器械注册人、备案人、受托生产企业应当按照医疗器械生产质量管理规范，建立健全与所生产医疗器械相适应的质量管理体系并保证其有效运行；严格按照经注册或者备案的产品技术要求组织生产，保证出厂的医疗器械符合强制性标准以及经注册或者备案的产品技术要求。”的规定。应当依据《医疗器械监督管理条例》第八十六条第二项：“有下列情形之一的，由负责药品监督管理的部门责令改正，没收违法生产经营使用的医疗器械；违法生产经营使用的医疗器械货值金额不足1万元的，并处2万元以上5万元以下罚款；货值金额1万元以上的，并处货值金额5倍以上20倍以下罚款；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注册证、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、直接负责人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3倍以下罚款，10年内禁止其从事医疗器械生产经营活动：（二）未按照经注册或者备案的产品技术要求组织生产，或者未依照本条例规定建立质量管理体系并保持有效运行，影响产品安全、有效；”的规定予以处罚。鉴于当事人在案件调查过程中积极配合调查，违法行为情节轻微，社会危害后果较小，具有从轻情节，给予从轻处罚。综上，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，依据《医疗器械监督管理条例》第八十六条第二项的规定，责令当事人立即改正违法行为，建立完善医疗器械生产质量管理体系并保持有效运行，并给予天津市海诺德工贸有限公司以下处罚：1.没收违法生产的联机透析B干粉109筒；2.处罚款20000元。如当事人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申请行政诉讼。申请行政复议或者提起行政诉讼期间，行政处罚不停止执行。天津市药品监督管理局（印章）2025年1月3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。

为加强医疗器械监督管理，保障医疗器械产品质量安全有效，国家药品监督管理局组织对腹膜透析设备、导丝等5个品种进行了产品质量监督抽检，有8批（台）产品不符合标准规定。现将有关情况通告如下：一、 被抽检项目不符合标准规定的医疗器械产品（一）腹膜透析设备2台：分别为吉林省迈达医疗器械股份有限公司生产，涉及透析液温度、透析液过量灌注不符合标准规定；西安乐析医疗科技有限公司生产，涉及温度控制不符合标准规定。（二）肢体加压理疗设备2台：分别为山东泽普医疗科技有限公司生产，涉及输入功率不符合标准规定；西安市新希望医疗器械有限公司生产，涉及治疗程序不符合标准规定。（三）医用分子筛制氧机1台：广东欧格斯科技有限公司生产，涉及氧浓度不符合标准规定。（四）导丝2批：分别为安吉特（天津）科技有限公司、厦门鑫康顺医疗科技有限公司生产，涉及紫外吸光度不符合标准规定。（五）尿素测定试剂盒1批：上海高踪医疗器械科技有限公司生产，涉及线性范围不符合标准规定。以上抽检不符合标准规定产品具体情况见附件。二、监管要求对抽检发现的不符合标准规定产品，国家药品监督管理局已要求企业所在地省级药品监督管理部门按照《医疗器械监督管理条例》《医疗器械生产监督管理办法》《医疗器械召回管理办法》等要求，及时作出行政处理决定并向社会公布。省级药品监督管理部门要督促企业对抽检不符合标准规定产品进行风险评估，根据医疗器械缺陷的严重程度确定召回级别，主动召回产品并公开召回信息；督促企业尽快查明产品不合格原因，制定整改措施并按期整改到位。特此通告。附件：抽检不符合标准规定产品名单国家药监局2025年1月6日附件抽检不符合标准规定产品名单序号标示产品名称被抽查单位标示注册人、代理人规格型号生产日期/批号/出厂编号抽样单位检验单位不符合标准规定项目1腹膜透析机　吉林省迈达医疗器械股份有限公司吉林省迈达医疗器械股份有限公司FM-Ⅰ　2024年1月510M01吉林省药品监督管理局　广东省医疗器械质量监督检验所1.透析液温度；2.透析液过量灌注　2腹膜透析机　西安乐析医疗科技有限公司西安乐析医疗科技有限公司RSA-1.0　2024-03-22200500030陕西省药品监督管理局　广东省医疗器械质量监督检验所温度控制　3空气压力波治疗仪　山东泽普医疗科技有限公司山东泽普医疗科技有限公司ZEPU-K2　2024年03月22日05222308002山东省药品监督管理局　北京市医疗器械检验研究院输入功率　4动静脉脉冲气压治疗仪　西安市新希望医疗器械有限公司西安市新希望医疗器械有限公司XXW-YFVTE-02　2023/04/30323000832300080178陕西省药品监督管理局　河北省药品医疗器械检验研究院治疗程序　5制氧机西藏阜康健康管理有限公司医药超市广东欧格斯科技有限公司OZ-5-01TW02023.05.03202305033230503001908西藏自治区药品监督管理局四川省药品检验研究院（四川省医疗器械检测中心）氧浓度6一次性使用指引导丝　安吉特（天津）科技有限公司安吉特（天津）科技有限公司AGT-BMW1906　20230621202306001天津市药品监督管理局　山东省医疗器械和药品包装检验研究院紫外吸光度　7一次性使用亲水涂层导丝　厦门鑫康顺医疗科技有限公司厦门鑫康顺医疗科技有限公司QS-035-150　2023-8-1532308086福建省药品监督管理局　山东省医疗器械和药品包装检验研究院紫外吸光度　8尿素(UREA)检测试剂盒（谷氨酸脱氢酶法）　上海高踪医疗器械科技有限公司上海高踪医疗器械科技有限公司150ml(R1:2×60ml,R2:1×30ml)　2024.01.0420240102上海市药品监督管理局　江苏省医疗器械检验所线性范围　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。