各省、自治区、直辖市药品监督管理局：根据原国家食品药品监督管理局、中华人民共和国卫生部《关于将A型肉毒毒素列入毒性药品管理的通知》（国食药监办〔2008〕405号）要求，兰州生物技术开发有限公司对2020年以来确认和指定的125家A型肉毒毒素经营企业进行资格重新确认，确认109家，取消16家。现将重新确认和取消A型肉毒毒素经营企业名单（见附件1、2）予以函告。 附件1重新确认注射用A型肉毒毒素药品经营企业名单省、自治区、直辖市数量企业名称北京市3国药集团药业股份有限公司国药控股北京有限公司科园信海（北京）医疗用品贸易有限公司天津市3国药控股生物医药（天津）有限公司国药控股（天津）东方博康医药有限公司天津九州通达医药有限公司河北省2国药乐仁堂医药有限公司河北美康太平医药贸易有限公司山西省3国药集团山西有限公司山西九州通医药有限公司华润山西医药有限公司内蒙自治区6包头市医药有限责任公司华润内蒙古医药有限公司包头市统一医药有限责任公司国药控股赤峰有限公司呼伦贝尔九州通医药有限公司内蒙古九州通医药有限公司辽宁省4国药控股大连有限公司国药控股沈阳有限公司辽宁省医药有限公司华润辽宁医药有限公司吉林省2吉林省真承药业有限公司华润吉林医药有限公司黑龙江省5黑龙江省同泽医药有限公司国药控股黑龙江有限公司哈药集团医药有限公司药品分公司黑龙江九州通医药有限公司上药科园信海黑龙江医药有限公司上海市4国药控股东虹医药（上海）有限公司上药康德乐罗达（上海）医药有限公司国药控股分销中心有限公司国药控股股份有限公司江苏省3国药控股扬州有限公司国药控股江苏有限公司江苏康缘琴纳医药有限公司浙江省5华东医药（杭州）生物制品有限公司华东医药股份有限公司浙江长典医药有限公司国药控股浙江生物制品有限公司物产中大华妍科技（浙江）有限公司安徽省3国药控股安徽省医药有限公司安徽中生安兰生物技术有限公司国药控股安徽有限公司福建省4国药控股福州有限公司国药控股福建有限公司福建中鹭医药有限公司厦门汉丰医药有限公司江西省4国药控股江西有限公司江西五洲医药营销有限公司江西汇仁医药贸易有限公司江西南华医药有限公司山东省7华润山东医药有限公司山东海王银河医药有限公司国药控股山东有限公司国药控股青岛有限公司瑞康医药集团股份有限公司山东大舜医药物流有限公司瑞康医药（山东）有限公司河南省4华润河南医药有限公司通用技术河南省医药有限公司国药控股河南股份有限公司重庆医药集团河南有限公司湖北省6国药控股湖北有限公司国药控股湖北新特药有限公司国药控股襄阳有限公司湖北人福医药集团有限公司九州通医药集团股份有限公司上药康德乐（湖北）医药有限公司湖南省3国药控股湖南有限公司上药控股(湖南)有限公司湖南九州通医药有限公司广东省6国药集团一致药业股份有限公司国药控股广州有限公司广东瀚泽医药有限公司国药控股深圳健民有限公司华润广东医药有限公司广东佳丰生物制品有限公司广西壮族自治区4广西柳药集团股份有限公司国药控股广西有限公司广西智圆行医药有限公司国药控股柳州有限公司海南省1国药控股海南有限公司重庆市5重庆汉鑫医药有限公司国药控股重庆有限公司重庆医药集团药特分有限责任公司康友益源（重庆）医药有限公司重庆医药（集团）股份有限公司四川省2上药控股四川生物制品有限公司国药集团西南医药有限公司贵州省3贵州信邦药业有限公司国药控股贵州有限公司 贵州九鑫医药药材有限责任公司云南省3国药控股云南有限公司云南省医药有限公司上药控股云南有限公司西藏自治区1国药西藏医药有限公司陕西省3陕西兰生医药生物技术有限责任公司国药控股陕西有限公司陕西华氏医药有限公司甘肃省4国药控股甘肃有限公司甘肃普佳医药有限公司国药控股兰州盛原医药有限公司甘肃兰生生物药业有限公司青海省2青海省医药有限责任公司国药控股青海有限公司宁夏回族自治区2国药控股宁夏有限公司重庆医药集团（宁夏）有限公司新疆维吾尔自治区2重庆医药（集团）新疆有限公司国药集团新疆新特药业有限公司 附件2注销注射用A型肉毒毒素药品经营企业名单省、区、市数量企业名称原因吉林省1国药控股吉林有限公司业务整合取消上海市2上海振申医药进出口有限公司未经营上海康桥药业有限公司业务整合取消浙江省1华东宁波医药有限公司业务整合取消江西省1国药控股赣州有限公司业务整合取消湖北省2国药控股武汉有限公司业务整合取消武汉哈瑞医药有限公司业务整合取消湖南省2湖南省永康生物制品有限公司业务整合取消国药控股长沙有限公司未经营广西壮族自治区2广西南宁康华医药有限公司业务整合取消广西南宁恒泰生物技术有限公司业务整合取消海南省1国药控股海南鸿益有限公司业务整合取消重庆市2重庆医药集团药销医药有限公司业务整合取消国药集团重庆医疗器械有限公司业务整合取消宁夏回族自治区1宁夏玖如泰医药有限公司业务整合取消新疆维吾尔自治区1新疆利生医药药材有限公司未经营 甘肃省药品监督管理局2025年11月26日

依据《黑龙江省行政规范性文件制定和监督管理办法》（省政府令第5号），我局对有效期即将届满的《黑龙江省医疗器械运输贮存服务监督管理工作指导意见（试行）》（黑药监规〔2023〕9号）进行评估，决定对该文件有效期延续2年，至2027年12月28日。在文件继续执行期间，如有修改或废止，以新修改文件公布或废止的通知为准。相关附件：《关于印发〈黑龙江省医疗器械运输贮存服务监督管理工作指导意见（试行)〉的通知》（黑药监规〔2023〕9号）黑龙江省药品监督管理局2025年12月2日

各市（州）市场监督管理局，省药监局各处室、检查分局、直属单位：《四川省药品监管领域轻微违法行为不予处罚清单》已经2025 年11月25日省药监局第10次局长办公会议通过，现印发给你们，自2026年1月1日起施行。  四川省药品监督管理局2025年12月2日                                                 四川省药品领域轻微违法行为不予处罚清单

　奥林巴斯贸易（上海）有限公司报告，由于涉及产品在使用过程中可能无法按预期释放或脱离等原因，生产商奥林巴斯医疗株式会社オリンパスメディカルシステムズ株式会社对其生产的一次性使用结扎装置（国械注进20172026749）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12月2日

美敦力（上海）管理有限公司报告，美敦力全球在特定型号特定批次的5盒活化凝血时间测定试剂盒（凝固法）的外部纸箱标签和使用说明书（IFU）上发现了微量干血痕迹。截至目前，美敦力全球尚未收到任何与该问题相关的投诉和不良事件。生产商Medtronic Inc.对其生产的活化凝血时间测定试剂盒（凝固法）HR-ACT Cartridge（国械注进20172401652）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12月2日

    为深入贯彻落实《国务院办公厅关于严格规范涉企行政检查的意见》（国办发〔2024〕54号）精神，进一步规范全省药品监管领域涉企行政检查行为，持续优化营商环境，省药监局组织起草了《安徽省药品监管领域涉企行政检查负面清单（征求意见稿）》（具体内容见附件），现公开征求意见。若有修改意见和建议，请于2025年12月18日前，书面或通过电子邮件反馈。通讯地址：合肥市包河区马鞍山路509号省政务大厦B区1314，邮政编码：230051，电子邮箱：zcfgc2017@126.com。联系人及电话：蔡珊珊，0551-62999293。附件：1.安徽省药品监管领域涉企行政检查负面清单（征求意见稿）       2.安徽省药品监管领域涉企行政检查负面清单起草说明（征求意见稿）安徽省药品监督管理局2025年12月2日

安徽省药品监督管理局第一分局药品流通监督检查信息通告（2025年11月）.xls

经对湖南隆发医药科技有限公司飞行检查综合评定，结果不符合规定，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、《药品经营和使用质量监督管理办法》第六十三条的规定，2025年11月25日起对上述企业采取暂停药品销售的风险控制措施。现予以通告（企业详情见附件）。附件：暂停药品销售企业信息湖南省药品监督管理局2025年12月2日   （公开属性：主动公开）附件暂停药品销售企业信息序号企业名称经营地址仓库地址经营范围许可证编号检查发现的主要缺陷问题1湖南隆发医药科技有限公司长沙市雨花区同升街道环保中路188号2号厂房B604长沙市雨花区同升街道环保中路188号2号厂房B204、B304、B404、B504中药饮片（不含罂粟壳）、化学药（含原料药）、生物制品（不含细胞治疗类生物制品、不含血液制品）、中成药、（不含冷藏药品、不含冷冻药品）湘AA731a00243计算机系统不能满足药品可追溯要求；从非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

Delivery Method:Via Electronic Mail - Return Receipt RequestedReference #:320-26-17Product:DrugsRecipient:Mr. Glen S. PutnamSenior Director of Global QualityRhyz Analytical Labs75 West Center St.Provo,UT84601-4432United StatesIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter320-26-17November 12, 2025Dear Mr. Putnam:The United States Food and Drug Administration (FDA) inspected your contract testing laboratory, Rhyz Analytical Labs, FEI 3020181366 at 75 West Center Street, Provo, from June 2 to 5, 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, the drug products you tested 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 June 25, 2025, response to our Form FDA 483 in detail.During our inspection, our investigators observed specific violations including, but not limited to, the following.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).Your facility is a contract testing laboratory that conducts chemical and microbiological testing of various over-the-counter drug products for your customers. Your firm lacked adequate investigations into multiple test results that failed the microbiological specifications for drug products. For example, your investigation into microbial excursions in a lot of(b)(4)indicated a root cause of “unknown laboratory error” and concluded “contamination of an unknown source.” You noted the corrective action and preventive action (CAPA) as investigating potential sources of contamination and retraining of analysts.You repeatedly accepted this conclusion and CAPA in at least five investigations without sufficient scientific justification to support your identified root cause. You incorrectly relied on the retest data without adequately investigating the potential contamination source prior to retesting. Furthermore, you did not assess the effectiveness of your proposed CAPA. Well-documented, thorough, and scientifically sound investigations are necessary to identify the root cause and implement the appropriate and effective CAPA.In your response, you acknowledge the gaps in your procedures and lack of a formal system for handling out-of-specification (OOS) test results. You commit to reviewing your investigation procedures and revising them.Your response is inadequate because it does not provide a review of your operational elements that may introduce microbial contamination into samples and the corrective actions implemented to prevent recurrence.In response to this letter, provide:A retrospective, independent review of all invalidated OOS results for U.S. products for the last three years from the initial date of inspection and a report summarizing the findings of the analysis, including the following for each OOS:o Determine whether the scientific justification and evidence relating to the invalidated OOS result conclusively or inconclusively demonstrates causative laboratory error.o For investigations that conclusively establish laboratory root cause, provide rationale and ensure that all other laboratory methods vulnerable to the same or similar root cause are identified for remediation.A comprehensive review and remediation plan for your OOS result investigation systems. The CAPA should include, but not be limited to, addressing the following:o Quality unit oversight of laboratory investigationso Identification of adverse laboratory control trendso Resolution of causes of laboratory variationo Adequately scoping of each investigation and its CAPAo Revised OOS investigation procedures with these and other remediations2. Your firm failed to establish adequate written responsibilities and procedures applicable to the quality control unit (21 CFR 211.22(d)).Your quality unit (QU) failed to exercise adequate oversight over your contract testing operations. For example, your QU failed to adequately:Establish procedures for critical operations including responsibilities and procedures applicable to a QU, handling of deviations, change control, and cleaning procedures.Implement and follow adequate procedures for laboratory investigations.In your response, you identify the lack of a quality management system as the root cause for this deficiency and commit to creating procedures for items noted above.Your response is inadequate because you fail to assess the impact of your quality system deficiencies on the test data reported to your customers. You also fail to provide a comprehensive assessment and remediation plan of your quality systems to ensure they function effectively.Your firm’s quality systems are inadequate. See FDA’s guidance documentQuality Systems Approach to Pharmaceutical Current Good Manufacturing Practice 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:o A determination of whether procedures used by your firm are robust and appropriateo Provisions for QU oversight throughout your operations to evaluate adherence to appropriate practiceso Oversight and approval of investigations and discharging of all other QU duties to ensure identity, strength, quality, and purity of all productsConclusionThe 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 3020181366 and ATTN: Marisa Heayn.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and Research