全省各化妆品注册人、备案人、生产经营企业：为保障2025年“双十一”期间我省化妆品质量安全，江西省药品监督管理局就相关工作提醒如下：一、严格按照《化妆品生产质量管理规范》建立健全质量管理体系并保证持续稳定运行，加强生产管理，保障产品质量。对委托生产的品种，委托方应与受托方签订明确的质量协议，双方均应严格按法规要求和质量协议履行责任义务。二、对照《江西省化妆品经营十规范十不准》等相关规定开展自查，做好进货查验记录，做到来源可追溯。对生产、销售产品（包括试用装、赠品），确保化妆品标签、功能宣称符合相关规定。针对产品特点规范宣传广告及产品说明书，避免虚假夸大宣传。三、按照《化妆品网络经营监督管理办法》规定履行化妆品信息披露的义务，全面、真实、准确、清晰、及时披露与注册或者备案资料一致的化妆品标签等信息。四、认真做好产品售后服务、不良反应监测、缺陷产品召回等相关工作，切实提升消费者的消费体验。江西省药品监督管理局 2025年10月20日

根据《中华人民共和国行政许可法》《中华人民共和国药品管理法》《药品经营和使用质量监督管理办法》等规定，现决定依法注销江西盛欣医药有限公司、江西医健宝药房连锁有限公司的《药品经营许可证》（详见附件）。特此公告。附件：注销药品经营许可证企业名单 江西省药品监督管理局 2025年10月21日附件注销药品经营许可证企业名单序号企业名称法定代表人许可证编号注册地址注销原因1江西盛欣医药有限公司魏和圣赣AA7960604江西省吉安市峡江县工业园区月华路30号主动申请注销2江西医健宝药房连锁有限公司王发明赣BA795000283江西省樟树市药都南大道99号2号楼一层主动申请注销

　　飞利浦（中国）投资有限公司报告，由于Zenition 50图像增强器（11W）控制板的潜在腐蚀情况，可能会导致设备成像功能缺失和/或图像质量不好等原因，生产商飞利浦医疗系统荷兰有限公司对其生产的移动式C形臂X射线机（国械注进20203060476）主动召回。召回级别为三级召回。涉及产品的型号、规格及批次等详细信息见《医疗器械召回事件报告表》。　　附件：医疗器械召回事件报告表　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　2025年10月21日

　　柯惠医疗器材国际贸易（上海）有限公司报告，由于在制造过程中，外壳管压制环节存在内部制造问题等原因，生产商柯惠有限责任公司Covidien llc对其生产的一次性使用腔镜下预置芯片切割吻合器钉匣Signia Small Diameter Reloads（国械注进20233010130）主动召回。召回级别为三级召回。涉及产品的型号、规格及批次等详细信息见《医疗器械召回事件报告表》。　　　附件：医疗器械召回事件报告表　　　　　　　　　　　　　　　2025年10月21日

　　北京微仙医疗科技有限公司报告，收到投诉及医疗器械报告（MDRs），显示特定批次的产品存在钽丝长度和（或）钽丝附着方式相关制造问题，可能导致手术中器械输送/打开异常，引发手术延误。生产商美科微先公司MicroVention, Inc.对其生产的血流导向密网支架Flow Re-Direction Endoluminal Device (FRED) X System（国械注进20253130217）主动召回。召回级别为二级召回。涉及产品的型号、规格及批次等详细信息见《医疗器械召回事件报告表》。　　附件：医疗器械召回事件报告表　　　　　　　　　　　　　　　2025年10月21日

　　捷迈（上海）医疗国际贸易有限公司报告，由于44mm和46mm的VIVACIT-E VE 抗氧化高交联聚乙烯双动髋臼内衬出现混批，生产商美国捷迈公司Zimmer Inc.对其生产的髋关节假体-髋臼内衬Dual Mobility Vivacit-E Polyethylene Hip Bearing（国械注进20233130291）主动召回。召回级别为三级召回。涉及产品的型号、规格及批次等详细信息见《医疗器械召回事件报告表》。　　附件：医疗器械召回事件报告表　　　　　　　　　　　　　　　　2025年10月21日

　　为强化对医药创新产品的全过程保障，市药监局第二分局对辖区药品临床试验机构所有在研创新药试点项目实施常态化、全覆盖监督检查。通过预警前置、精准指导，严把药品研发关口，切实守护人民群众用药安全，为医药创新高质量发展保驾护航。目前，已完成2家机构6个在研试点项目监督检查。　　一是坚持主动介入，实现监督指导同步。推动药品监管关口前移，将监督约束与帮扶指导贯穿于工作全流程，实现“防风险”与“促发展”有机统一。建立创新药试点项目动态清单，指定专人对接，采取定期走访、电话访谈等方式，全程跟踪项目进展，针对试验过程中的难点堵点，及时提供法规咨询和技术指导，同步压实责任与传导方法。　　二是汇聚专家智慧，实施精准风险防控。积极引入外部智力支持，邀请知名机构权威专家组成顾问团，深度参与创新药试点项目监管工作，提升药品监管科学性、专业性。基于创新药项目多样性及高风险特性，依托专家力量重点强化对临床试验设计及执行等关键环节的风险研判与过程监督，提升风险识别与管控能力，切实守住药品安全底线。　　三是强化过程监管，筑牢试验质量根基。严格履行药物临床试验机构监管职责，通过常态化监督检查，切实保障临床试验过程规范、数据真实可靠。对伦理审查、受试者保护、方案执行及数据记录等关键环节实施全覆盖重点检查，督促机构对发现的问题立即整改，深入分析原因，制定预防措施，压实主体责任，确保临床试验研究质量，为药品审评审批提供可靠依据。　　下一步，市药监局第二分局将持续完善创新药试点项目全覆盖监管机制，探索智慧监管方式，不断提升监管效能，为推动首都医药产业创新发展、保障公众健康贡献力量。

根据《药品经营和使用质量监督管理办法》第二十七条第一款的规定，该企业主动提出注销《药品经营许可证》，我局已依法办理了福建药福家医药连锁有限公司《药品经营许可证》（证号：闽BA594000064）注销手续,现予以公告。请各有关药品监督管理部门监督该企业不得再以已注销《药品经营许可证》企业的名义经营药品，并请社会各界共同监督。监督电话：0591－86296506联系地址：福州市鼓楼区五四路358号福建省药品监督管理局邮编：350003福建省药品监督管理局2025年10月21日

根据《中华人民共和国行政许可法》《中华人民共和国药品管理法》《药品经营和使用质量监督管理办法》等规定，现决定依法注销江西盛欣医药有限公司、江西医健宝药房连锁有限公司的《药品经营许可证》（详见附件）。特此公告。附件：注销药品经营许可证企业名单 江西省药品监督管理局 2025年10月21日序号企业名称法定代表人许可证编号注册地址注销原因1江西盛欣医药有限公司魏和圣赣AA7960604江西省吉安市峡江县工业园区月华路30号主动申请注销2江西医健宝药房连锁有限公司王发明赣BA795000283江西省樟树市药都南大道99号2号楼一层主动申请注销

Delivery Method:VIA UPSReference #:320-26-03Product:DrugsRecipient:Mr. Walter C. JohnsenCEOAcme United Corporation1 Waterview Drive Suite 200Shelton,CT06484United StatesIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter320-26-03October 10, 2025Dear Mr. Johnsen:The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Acme United Corporation, FEI 3012129555, at 301 Marianne St., Shelton, CT, from March 18 to 28, 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 reviewed your April 18, 2025 response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence.During our inspection, our investigator observed specific violations including, but not limited to, the following.1. Your firm failed to use equipment in the manufacture, processing, packing, or holding of drug products that is of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance. Your firm also 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 211.63 and 21 CFR 211.192).Your firm used(b)(4)water as a component to manufacture your topical over-the-counter (OTC) drug products, such as antiseptic wipes, labeled as sterile and non-sterile. You failed to adequately design and control your(b)(4)water system to ensure that it was suitable for producing water used in the formulation of your drug products. For example, you isolated the objectionable microorganismBurkholderia cepacia (B. cepacia)on numerous occasions within the holding tank and at the point of use. You regularly sanitized your water system after recoveringB. cepacia, yet you continued to recoverB. cepaciashortly after those repeated sanitization cycles. Microbiological monitoring of your system also yielded several “too numerous to count” results at multiple points in the system. These data indicated the presence of a recalcitrant biofilm. Furthermore, your firm failed to conduct timely and comprehensive investigations into these out-of-limit (OOL) microbiological results, including documenting root cause determinations and product impact assessment.We acknowledge you recently installed a new water system. We note that this system, based on discussions during our inspection, appears to be an on-demand system without continuous circulation.In your response, you state you do not believe your products pose a safety risk to consumers. For your non-sterile drug products, you indicate that there is a low potential impact to the end user because little to no microbial contamination was recovered from batch samples. You also indicate the active ingredient has an anti-microbial effect. Your response is inadequate. Antimicrobial formulations are not a substitute for adequate CGMP. Additionally, it is important to note that microbial contamination is not uniformly distributed, and samples may not be representative of the type or level of contamination that may exist within an entire system.Your new water system continues to have deficient elements that do not assure long-term system reliability and suitable water quality. The(b)(4)water system must be adequately designed and properly maintained to minimize the potential for contamination. For example, stagnant water from an on-demand, non-recirculating system can foster the development of biofilms.(b)(4)water must be suitable for its intended use and routinely tested to ensure ongoing conformance with appropriate chemical and microbiological attributes.In response to this letter, provide:A comprehensive assessment of your water system design, control, and maintenance. Regarding system control, for example, explain whether your firm is utilizing a recirculating water system and whether heat is an element of the system. In addition, state the duration, if any, that your water system is continuously circulating, and provide your rationale for any duration less than 24 hours.A thorough independent assessment to ensure you have installed and are operating a suitable water system, accompanied by a remediation plan to address any identified deficiencies. Also, include a robust ongoing control, maintenance, and monitoring program to ensure the new system consistently produces water adhering to(b)(4)Water, USP monograph specifications, and appropriate microbial limits.Regarding the latter, ensure that your total microbial count limits and objectionable microbiological standards for water are appropriate in view of the intended use of the products produced by your firm.An updated risk assessment addressing the potential effects of the observed water system failures on the quality of all drug product lots currently in U.S. distribution. Specify actionsthat you will take in response to the risk assessment, such as customer notifications and product recalls.An action plan and timelines for conducting full microbiological testing of retain samples of your non-sterile finished drug products to determine the quality of all batches of drug product distributed to the United States that are within expiry. You should test all appropriate quality attributes including, but not limited to, microbiological quality (total counts and identification of bioburden to detect any objectionable microbes) of each batch. If testing yields an OOL result, indicate the corrective actions you will take, including notifying customers and initiating recalls.A summary of all data from all (e.g., accelerated, annual) stability studies from the last five years. Include all lots, all timepoints, and any out-of-specification (OOS) results, irrespective of whether they were later invalidated.A summary table of all individual microbial test results (total counts and identification of bioburden to detect any objectionable microbes) obtained from testing samples from your new water system. Also, include all physical and chemical test results (total organic carbon, conductivity, etc.)A retrospective review of all invalidated OOL water test results, including the following for each OOL:• For all OOL results found by the retrospective review to have an inconclusive or no root cause identified in the laboratory, include a thorough review of production (e.g., batch manufacturing records, adequacy of the manufacturing steps, suitability of equipment/facilities, variability of raw materials, process capability, deviation history, complaint history, batch failure history). Provide a summary of potential manufacturing root causes for each investigation, and any manufacturing operation improvements.A comprehensive review and remediation plan for your OOS/OOL result investigation systems. The corrective action and preventative action (CAPA) should include but not be limited to addressing the following:• Quality unit oversight of laboratory investigations• Identification of adverse laboratory control trends• Resolution of causes of laboratory variation• Initiation of thorough investigations of potential manufacturing causes whenever a laboratory cause cannot be conclusively identified• Adequately scoping of each investigation and its CAPA• Revised OOS/OOL investigation procedures with these and other remediations2. Your firm failed to establish written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess. Your firm also failed to follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all sterilization processes (21 CFR 211.100(a) and 21 CFR 211.113(b)).You failed to adequately validate your production and process controls used in the manufacture of your drug products. Additionally, you failed to conduct adequate qualification activities for equipment used to manufacture your drug products.Furthermore, your firm failed to follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that included validation of all sterilization processes. For example, your firm has not performed quarterly dose audit studies to monitor the(b)(4)dose to ensure that it remains effective for the(b)(4)sterilization of your drug products intended to be sterile.In your response, you state that you will develop and implement enhanced process controls and complete process validation studies. Your response is inadequate as it did not provide a timeframe for completion of process validation activities for each of your drug products. In addition, your response did not include your interim plan for any drugs distributed before validation activities are completed to ensure you produce drug products of acceptable quality.Process validation evaluates the soundness of design and state of control of a process throughout its lifecycle. Each significant stage of a manufacturing process must be designed appropriately and assure the quality of raw material inputs, in-process materials, and finished drugs. Process qualification studies include intensive monitoring and testing throughout each significant process stage to characterize intra-batch variation and evaluate batches to determine whether an initial state of control has been established.Successful process qualification studies are necessary before commercial distribution. Thereafter, ongoing vigilant oversight of process performance and product quality is necessary to ensure you maintain a stable manufacturing operation throughout the product lifecycle. See FDA’s guidance for industry,Process Validation: General Principles and Practices, for general principles and approaches that the FDA considers appropriate elements of process validation athttps://www.fda.gov/regulatory-information/search-fda-guidance-documents/process-validation-general-principles-and-practices.In response to this letter, provide:A detailed summary of your validation program for ensuring a state of control throughout the product lifecycle, along with associated procedures. Describe your program for process performance qualification, and ongoing monitoring of both intra-batch and inter-batch variation to ensure a continuing state of control.A timeline for performing process performance qualification for each of your marketed drug products. Also provide a risk assessment and any follow-up actions to be taken for the distributed drug products produced without performing any process validation studies.A detailed program for designing, validating, maintaining, controlling and monitoring each of your manufacturing processes that includes vigilant monitoring of intra-batch and inter-batch variation to ensure an ongoing state of control. As part of your response, explain how you handle changes throughout the lifecycle, including determining whether any changes (e.g., materials, manufacturing process, atypical bioburden) adversely impact the effectiveness of your(b)(4)sterilization process. Finally, include your program for qualification of your equipment and facility.A list of all quality complaints for the past five years. Include the batch number, name of product, lot size, whether a complaint sample was received (if not, explain why), and description of any associated CAPA.3. Your firm failed to conduct appropriate laboratory testing to determine whether each batch of drug product purporting to be sterile conforms to such requirements (21 CFR 211.167(a)).Your firm released your finished OTC drug products to the U.S. market without testing each batch for all appropriate quality attributes. For example, your firm distributed multiple batches of purportedly sterile finished drug products without conducting sterility testing. Without testing all appropriate physical and microbiological quality attributes of your drug products, your quality unit lacks essential safety information required to make suitable batch release decisions.In your response, you acknowledge that you did not begin sterility testing on your drug products until the end of 2024. You indicate that you will test the retains, per USP Sterility Tests, of lots for which you have retains.Your response is inadequate because you have not provided proof of method suitability of the sterility test performed by your contract laboratory to ensure its capability to detect microbes in your finished drug product. Additionally, you have failed to indicate if there are batches for which you lack retains and are therefore unable to test for sterility.In response to this letter, provide:A comprehensive, independent assessment of your laboratory practices, procedures, methods, documentation, supervision, and analyst competencies. Based on this review, provide a detailed CAPA plan to remediate your laboratory system. If a contract facility performs any laboratory functions on your behalf, conduct an equivalent comprehensive assessment of their practices, implement an appropriate supplier CAPA, monitor the remediations at the contractor, and provide a summary of these planned CAPA activities.A summary of all test results obtained from testing your batch retains, including any OOS/OOL results obtained (irrespective of whether later invalidated). Also include a list of batches for which you have no retains and are unable to test for sterility.A list of microbial test methods and specifications used to analyze each batch of your drug product before making a batch disposition decision, and the associated written procedures.Method suitability tests performed for each of your formulations.Quality SystemsYour firm’s quality systems are inadequate. For guidance on establishing and maintaining CGMP-compliant quality systems, see these FDA guidance documents:Q8(R2) Pharmaceutical Developmentat https://www.fda.gov/regulatory-information/search-fda-guidance-documents/q8r2-pharmaceutical-developmentQ9 Quality Risk Managementat https://www.fda.gov/regulatory-information/search-fda-guidance-documents/q9r1-quality-risk-managementQ10 Pharmaceutical Quality Systemat https://www.fda.gov/regulatory-information/search-fda-guidance-documents/q10-pharmaceutical-quality-systemConclusionThe 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 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.After you receive this letter, respond to this office in writing within 15 working days. In response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices, and/or submit a request to schedule an FDA inspection.Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 3012129555 and ATTN: Nancy Scheraga.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and Research