海南制药厂有限公司制药二厂因小容量注射剂不符合《药品生产质量管理规范》要求，我局依法对该企业小容量注射剂采取暂停生产销售的风险控制措施，并责令该企业进行整改。　　经药品GMP现场检查和整改复查及技术评定，认为该企业小容量注射剂已整改到位，符合《药品生产质量管理规范》要求。依据《药品生产监督管理办法》第五十九条的规定，我局依法解除对该企业小容量注射剂采取的暂停生产销售风险控制措施。　　特此通告。　　2025年10月29日

　　因印度本地的产品标签上显示错误的生产地址，波士顿科学公司Boston Scientific Corporation正在仅对印度主动召回特定型号批次的一次性使用胆胰管内窥镜导管SpyScope DS II Access and Delivery Catheter（国械注进20222060214）。召回级别为三级召回。该问题已得到充分调查和解决，预计不会造成任何伤害或不良健康后果，因为该问题不影响产品性能。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29日

　　雅培医疗用品（上海）有限公司报告，由于涉及产品因对带状线缆连接接口的过度操作可能造成系统控制器备用电池警报的问题，生产商雅培医疗器械 Abbott Medical对其生产的植入式左心室辅助系统Left Ventricular Assist System（国械注进20243120384）主动召回。召回级别为一级召回。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29日

10月27日，海南省药监局召开专题会议，调度推进零售药店药品追溯工作，客观分析当前形势，研究制定针对性举措，对决战决胜加快实现100%覆盖目标进行再动员、再部署。会议指出，全面推进药品追溯体系建设，是践行“人民至上、生命至上”理念、保障人民群众用药安全的关键抓手，是服务海南自贸港建设大局、构筑封关运作条件下流通领域药品安全防线的必然要求。它不仅是药品经营环节“清源行动”的“压舱石”，能够构筑起药品全链条闭环监管的坚固防线;也是医保基金管理突出问题专项整治“百日行动”的“防火墙”，可以为守好老百姓的“救命钱”提供精准数据支撑;更是整治群众身边腐败问题的“透视镜”，必将有力净化药品流通市场环境。会议指出，建设药品追溯节点平台，打通“最后一公里”技术路径，只是万里长征第一步。虽然截至今年10月底，全省医保定点零售药店医保品种覆盖率达到98.6%，但存在非定点药店和非重点品种的覆盖率低、各市县的区域进展不平衡、工作推进存在“上热下冷”等突出问题，部分药店仍有“不想扫、不会扫、扫不全”的情况，监管责任在一些地方存在“悬空”风险，部门间主体间数据协同壁垒尚未完全打破，药品追溯“最后一公里”亟待全量贯通。会议明确，必须采取超常规举措，举全局之力加快构筑起与海南自贸港药品流通新业态、新形势、新政策相符合的零售药店药品追溯责任体系、管理制度、技术平台。要以最严要求压实责任链条。在不额外增加企业负担的前提下，省药监局尽快制定出台零售药店药品追溯码全量应用的规范性文件，明确追溯系统全覆盖技术路径，压实属地药监部门的监管责任和零售药店的主体责任，构建起药品全链条安全监管闭环。要以最大合力强化协同联动。加强内部业务处室与技术机构的联动，形成业务提逻辑和需求、技术给路径和方案的监管合力。主动与省医保局对接，加快建立起药品追溯数据与医保结算数据一表采集、实时比对、互为支撑的工作格局。要以最优服务做好保障支撑。省药监局要组织技术团队下沉市县开展“一对一”培训，设立24小时技术服务热线，确保问题响应不过夜，年底前分片完成对全省所有零售药店的宣讲轮训。采取“四不两直”方式开展检查暗访，发挥“监督一张网”作用，形成有效抓落实的机制。会议强调，全省药监部门要以高度的政治责任感和历史使命感，迎难而上，真抓实干，向省委省政府和全省人民交上一份满意的答卷，为提升海南自贸港药品安全治理水平筑牢坚实根基。

Delivery Method:Via Electronic Mail - Delivery and Read Receipt RequestedReference #:320-26-07Product:DrugsRecipient:Mr. Robert KibbePresident and CEOThe Tranzonic Companies/Innocore Sales & Marketing Inc.26301 Curtiss Wright ParkwayCleveland,OH44143United StatesIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter320-26-07October 16, 2025Dear Mr. Kibbe:The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Innocore Sales & Marketing, Inc., FEI 3010034070, located at 399 Woodall Way, Woodstock, N4T 0K9, Ontario, Canada, from April 22 to 25, 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 May 16, 2025, response to our Form FDA 483 in detail.During our inspection, our investigator observed specific violations including, but not limited to, the following.1. Your firm failed to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release. Your firm also failed to conduct, for each batch of drug product, appropriate laboratory testing, as necessary, required to be free of objectionable microorganisms (21 CFR 211.165(a) and 211.165(b)).Your firm manufactures over-the-counter drug products such as(b)(4). You failed to conduct adequate finished product release testing for each batch of your drug product including, but not limited to, testing the identity and strength of the active ingredient,(b)(4), and testing for objectionable microorganisms.In your response, you state that you developed and will validate the titration and Fourier- transform infrared spectroscopy test methods, used for the(b)(4)assay and identification. You also state that you will investigate microbiological testing options for your finished drug products prior to release.Your response is inadequate because it lacks sufficient details regarding specific tests for each finished drug batch and fails to include a risk assessment or retrospective review of products released without appropriate testing.Without adequate finished product release testing, you do not have scientific evidence that each batch of drug product conforms to appropriate specifications before release.In your 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 list of chemical and microbiological specifications, including test methods, used to analyze each lot of your drug products before a lot disposition decision.o An action plan and timelines for conducting full chemical and microbiological testing of retain samples to determine the quality of all batches of drug product distributed to the United States that are within expiry as of the date of this letter.o A summary of all results obtained from testing retain samples from each batch. If such testing reveals substandard quality drug products, take rapid corrective actions, such as notifying customers and product recalls.2. Your firm failed to conduct at least one test to verify the identity of each component of a drug product (21 CFR 211.84(d)(1)).You failed to conduct adequate testing on incoming components, including an appropriate identity test of(b)(4), a component at higher risk for diethylene glycol (DEG) and ethylene glycol (EG) contamination. Identity testing for(b)(4), and certain other high-risk drug components includes a limit test in the United States Pharmacopeia (USP) to ensure that the component meets the relevant safety limits for levels of DEG or EG. Because you did not perform adequate identity testing on each shipment of each lot using the USP identification test that detects these hazardous impurities, you failed to assure the acceptability of these components for use in manufacture of your drug product.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/regulatory-information/search-fda-guidance-documents/testing-glycerin-propylene-glycol-maltitol-solution-hydrogenated-starch-hydrolysate-sorbitol.In your response, you state you have revised your raw material procedures regarding the component,(b)(4).Your response is inadequate because you failed to include a comprehensive review of your entire materials system, including test methods and compendial requirements. Furthermore, you did not consider testing retains of your(b)(4)and lacked a risk assessment of using inadequately tested(b)(4)in the manufacture of your distributed drug products.Without adequate testing, you lack scientific evidence that the components or drug products conform to appropriate specifications prior to use in the drug products you manufacture.In your response to this letter, provide:A commitment to provide DEG and EG test results, no later than 30 calendar days from the date of this letter, from testing retains for all lots of high-risk drug components used in the manufacture of drug products. Alternatively, if a retain of a component lot is unavailable, perform retain sample testing of all implicated finished drug product batches for the presence of DEG and EG.A full risk assessment for drug products that are within expiry which contain any ingredient at risk for DEG or EG contamination (including, but not limited to, glycerin). Take prompt and appropriate actions to determine the safety of all lots of the component(s) and any related drug product that could contain DEG or EG, including customer notifications and product recalls for any contaminated lots. Identify additional appropriate corrective actions and preventive actions that secure supply chains in the future, including, but not limited to, ensuring that all incoming raw material lots are from fully qualified manufacturers and free from unsafe impurities. Detail these actions in your response to this letter.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 certificate of analysis (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(b)(4), 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 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 establish and follow an adequate written testing program designed to assess the stability characteristics of drug products (21 CFR 211.166(a)).You lacked an adequate stability testing program for your drug products. For example, you lacked sufficient data to support the labeled expiry. You also lacked stability chambers to adequately store your stability samples. Further, the stability samples are not stored in the same container closure system in which your drug product is marketed.In your response, you state that you updated your stability program SOP to include requirements for finished packaged drug product stability data and that you anticipate commencing your stability program by(b)(4).Your response is inadequate because it lacks sufficient detail and does not provide a retrospective risk assessment for your drug products released without adequate stability testing.Without appropriate stability studies, you do not have scientific evidence to support whether your drug products meet established specifications and retain their quality attributes throughout their assigned shelf life.In response to this letter, provide:A comprehensive, independent assessment and corrective action and preventive action plan to ensure the adequacy of your stability program. Your remediated program should include, but not be limited to:o Stability-indicating methodso Stability studies for each drug product in its marketed container-closure system before distribution is permittedo 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 valido 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.4. Your firm’s quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP, and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22).Your firm failed to establish an adequate quality unit (QU) with the responsibilities and authority to oversee the manufacturing of drug products. For example, the QU failed to ensure:Establishment of an adequate cleaning and maintenance program for your manufacturing equipment and instruments. (21 CFR 211.67(a))Establishment of adequate batch records to include verification checks, appropriately detailed instructions, and labeling. (21 CFR 211.188)Adequate investigations with sustainable corrective actions including, but not limited to, unknown residues on equipment and out of specification cleaning rinse samples. (21 CFR 211.192)Your firm’s quality systems are inadequate. See FDA’s guidance documentQuality Systems Approach to Pharmaceutical CGMP Regulationsfor help implementing quality systems and risk management approaches to meet the requirements of CGMP regulations 21 CFR, parts 210 and 211 at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/quality-systems-approach-pharmaceutical-current-good-manufacturing-practice-regulations.In response to this letter, provide 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:A determination of whether procedures used by your firm are robust and appropriateProvisions for QU oversight throughout your operations to evaluate adherence to appropriate practicesA complete and final review of each batch and its related information before the QU disposition decisionOversight and approval of investigations and discharging of all other QU duties to ensure identity, strength, quality, and purity of all products.Also, describe how top management supports quality assurance and reliable operations including, but not limited to, timely provision of resources to proactively address emerging manufacturing/quality issues and to assure a continuing state of control.Repeat Observations at FacilityIn a June 2019 inspection, FDA cited similar CGMP observations. You proposed specific remediation for these observations in your response. Repeated failures demonstrate that executive management oversight and control over the manufacture of drugs is inadequate.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.Your use of a consultant does not relieve your firm’s obligation to comply with CGMP. Your firm’s executive management remains responsible for resolving all deficiencies and systemic flaws to ensure ongoing CGMP compliance.ConclusionThe violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations.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 Innocore Sales & Marketing, Inc., 399 Woodall Way, Woodstock, N4T 0K9, Ontario, Canada, into the United States under section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3). Articles under this authority that appear to be adulterated may be detained or refused admission in that the methods and controls used in their manufacture do not appear to conform to CGMP within the meaning of section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. 351(a)(2)(B).This letter notifies you of our findings and provides you an opportunity to address the above deficiencies. After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any violations and to prevent their recurrence. In response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion.Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 3010034070 and ATTN: Christopher M. Jenner.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and Research

经监督检查，东莞市东江医药有限公司等2家药品经营企业的综合评定结论为不符合要求，存在药品质量安全隐患。根据《中华人民共和国药品管理法》第九十九条及《药品检查管理办法（试行）》第六十一条规定，广东省药品监督管理局对东莞市东江医药有限公司等2家药品经营企业采取暂停销售（配送）风险控制措施，现予以公布。序号企业名称药品经营许可证编号综合评定结论风险控制措施1东莞市东江医药有限公司粤AA769000237不符合要求暂停销售2广东众德医药有限公司粤BA752000471不符合要求暂停销售（配送）　　企业应当严格落实主体责任，按照检查处理结果要求暂停销售（配送），排除质量安全隐患后，向广东省药品监督管理局提交整改报告，经复查符合条件后予以解除风险控制措施。　　特此通告。广东省药品监督管理局2025年10月25日

案件名称葫芦岛市顺康医药连锁有限公司涉嫌销售四味脾胃舒颗粒假药案处罚决定文书号辽药监(稽十四)罚〔2025〕3号被处罚企业名称葫芦岛市顺康医药连锁有限公司统一社会信用代码912114027915934461法定代表人孟凡鹏主要违法事实当事人销售假药“四味脾胃舒颗粒”，货值金额104元，违法所得2.42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、《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2.42元。行政处罚履行方式和期限主动履行；当事人已于2025年10月9日履行完毕。作出处罚的日期2025-09-29

桂林天和药业伊维有限公司于近日向我局提交了《药品生产许可证》注销申请。根据《中华人民共和国行政许可法》《药品生产监督管理办法》的相关规定，我局同意注销桂林天和药业伊维有限公司取得的《药品生产许可证》。特此公告。附件：1.注销《药品生产许可证》企业名单2.准予药品生产许可注销的决定（药监许决450000〔2025〕030259号）                  广西壮族自治区药品监督管理局                         2025年10月26日

依据《中华人民共和国行政许可法》第七十条、《执业药师注册管理办法》第二十四条的规定，现依法注销田盈等24人的《执业药师注册证》，并予以公告。　　附件：注销的注册证内容                                重庆市药品监督管理局                              　　　　　　　　　　　　　　　　　　　　　　　　　　2025年10月24日附件注销的注册证内容 序号姓名执业单位《执业药师注册证》编号1田盈重庆市北碚区安业大药房5022250900452王文玲重庆市麦克红康爱情谷药房5012250903333康玲重庆市明声宏辉大药房5012250903194胡静月重庆健本堂高莉大药房(个人独资）5012240400845路红梅重庆聚亿然润堂大药房有限公司一十二店5022240402196王利锋重庆市大渡口区然润堂大药房聚亿店5012210400237陈晓红重庆和时代大药房5012250400748华大文重庆健合春大药房有限公司5022240402289陈蓓重庆市大渡口区跃进万和药房有限公司钢花路二店50122304015610张娜玲重庆聚亿然润堂大药房有限公司一十五店50222404022711刘意重庆古臻道诊所有限公司大渡口春晖路中医诊所50232404001012石云方重庆市大渡口区天辰万和药房有限公司新山村店50122304017713王维重庆市大渡口区桐君阁景红大药房有限责任公司50122304008414张洁重庆鑫林旺大药房（个人独资）50222404011915罗静重庆好药师默沙大药房有限责任公司50122404005516罗静重庆红柳枝大药房有限公司50122404023517王新翠巫溪县名方大药房50222138004018方润巫溪县康圣百信大药房50222138005719林琼巫溪县康圣景天大药房有限公司50222238000920冉啟彩重庆市巫溪县应权大药房有限公司50222538003621张和军重庆市巫溪县福生堂集芳园药品超市50222238000522陈孝虹重庆康是美大药房有限公司巫溪印象南门公司50122338001323谭治全重庆康是美大药房有限公司巫溪塘坊分公司50122438003924陈雪林重庆康盛源大药房文峰店501221380011

经西双版纳州市场监督管理局调查证实，7名执业药师存在“挂证”行为，云南省执业药师注册中心依据《执业药师注册管理办法》（国药监人〔2021〕36号）规定，撤销其《执业药师注册证》，并将“挂证”执业药师的不良信息录入全国执业药师注册管理信息系统“奖惩记录”栏，现予公告。姓名资格证号注册证号注册单位官*萍20221102653000002989531225280002勐海慈安堂大药房（个人独资）念*臣20201002653000000632532224280142勐海琪健大药房刘*ZY00335291531220280205勐海玉仁堂药店肖*201810026530000930531225280434西双版纳康惠医药有限公司晏*雄ZY00331379531222280089西双版纳紫馨康医药有限公司郭*琼20211002655000000612531223280090云南郭中堂大药房吴*201910026530002503/20211002653000002334532225280402云南健源大药房有限公司勐海县勐阿分店云南省药品监督管理局2025年10月28日