为确保山西省中药材标准、中药饮片炮制规范制修订工作科学、规范、公正开展，进一步贯彻落实《山西省全面深化药品医疗器械监管改革 促进医药产业高质量发展若干措施(试行)》，根据《关于征集“山西省中药材标准、中药饮片炮制规范”评审专家的通知》及相关要求，经集中征集、审核遴选等程序，现将第一批拟入库的89位三晋名方优选工作评审专家名单予以公示，具体名单见附件。公示时间：2026年2月25日至2026年3月3日公示期内，任何单位和个人对名单有异议的，可通过来访、来电、来信等方式反映。联系方式：倪素丽  0351-7241446联系地址：山西省药品审评中心电子邮箱：sxyykyb@163.com附件：“山西省中药材标准、中药饮片炮制规范” 评审专家拟入库人员名单（89人）

辽宁省药品监督管理局行政处罚结果公示案件名称凌源星河医药连锁有限责任公司销售劣药“夫西地酸乳膏”案处罚决定文书号辽药监(稽十二) 罚〔2026〕4号被处罚企业名称凌源星河医药连锁有限责任公司统一社会信用代码91211382761819117M法定代表人吕仲明主要违法事实当事人销售劣药“夫西地酸乳膏”，但其进货渠道合法，提供的供货单位许可文件、产品合格证明、销售票据等真实合法；产品采购与收货记录、入库检查验收记录真实完整；产品的储存、养护、销售、使用、出库复核、运输按照有关规定执行且有真实完整的记录。有充分证据证明不知道所销售或者使用的药品是劣药。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》第一百一十七条第一款、《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60元。行政处罚履行方式和期限主动履行；当事人已于2026年2月12日履行完毕。作出处罚的日期2026-02-10

当事人基本信息行政处罚决定书文号违法行为类型处罚内容处罚决定日期行政相对人名称行政相对人类别行政相对人代码＿1（统一社会信用代码）法定代表人陕西鼎元祥医药有限公司法人91610104MA6X2G5B49弥春芳陕药监药罚〔2024〕5－1、5－2号违反《药品经营质量管理规范》案对公司处以以下行政处罚：1．罚款600000元；2．责令停业整顿10天。对相关责任人处以以下行政处罚：1．没收该公司企业负责人黄X违法行为发生期间在该公司所获收入，并处所获收入10％罚款；2、没收该公司法定代表人弥XX违法行为发生期间在该公司所获收入。2025年10月20日陕药监药罚〔2024〕5-1、5-2号处罚决定书

　　梅州市迪芬科技有限公司生产的尿液样本HPV病毒染色试剂，生产批号见附件，因产品部分资料描述与产品备案不一致，梅州市迪芬科技有限公司决定发起召回。　　梅州市迪芬科技有限公司对其生产的尿液样本HPV病毒染色试剂（注册证号：粤梅械备20220003 生产批号：见附件）主动召回。召回级别为三级。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.pdf2026年2月25日

行政处罚信息摘要行政处罚决定书文号当事人名称法定代表人姓名违法事实行政处罚内容和法律依据做出行政处罚的行政机关名称和日期新药监药处罚〔2026〕5 号新疆天山本草中药饮片有限公司刘*粉新疆天山本草中药饮片有限公司生产、销售的肉桂经检验不合格，为劣药。普通程序行政处罚案件，本局依据《中华人民共和国药品管理法》（2019年修订）第一百一十七条第二款及《中华人民共和国行政处罚法》第二十八条第二款之规定，责令新疆天山本草中药饮片有限公司改正相关违法行为，并做出行政处罚。新疆维吾尔自治区药品监督管理局，2026年2月6日

行政相对人名称四川新世纪医用高分子制品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）91510000201884076F法定代表人陈姬行政处罚决定书文号川药监处罚〔2025〕10002号违法行为类型未经许可从事第三类医疗器械经营活动违法事实未取得医疗器械经营许可证，销售第三类医疗器械处罚依据《医疗器械监督管理条例》（国务院令第739号）第八十一条第一款第（三）项处罚类别没收违法所得、罚款处罚内容处罚没款8.664万元处罚决定日期2026年2月11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

　　2025年，国家药监局以习近平新时代中国特色社会主义思想为指导，深入贯彻党的二十大和二十届历次全会精神，全面落实全国药品监督管理工作会议部署，持续完善支持创新医疗器械发展机制，全方位推进医疗器械审评审批制度改革走深走实，进一步强化医疗器械注册管理与审评能力建设，以监管效能提升人民群众用械安全，赋能产业创新高质量发展。　　一、医疗器械注册工作情况　　（一）扎实推进医疗器械监管法治建设。2025年，国家药监局继续推进《医疗器械管理法》制定，配合市场监管总局推进审查工作。发布《国家药监局关于进一步调整和优化进口医疗器械产品在中国境内企业生产有关事项的公告》，进一步鼓励跨国企业在中国境内生产，推动高水平对外开放。发布《关于医疗器械临床试验项目检查要点及判定原则的公告》，细化检查结果判定方法，明确法律衔接要求，推动临床试验项目管理规范化、标准化。发布《医疗器械注册自检核查指南》，为自检核查工作精细化开展提供依据。　　（二）着力支持重点领域医疗器械创新突破。2025年，国家药监局共批准创新医疗器械76个（同比增长17％）；优先审批医疗器械25个（同比增长212.5％），获批产品覆盖人工智能、肿瘤放射治疗、生物医用材料等多个前沿领域。发布《国家药监局关于优化全生命周期监管支持高端医疗器械创新发展有关举措的公告》，以政策集成创新支持高端医疗器械产业发展。研究制定“全球新”医疗器械中国首发工作机制，更加积极主动培育中国造“全球新”。聚焦脑机接口、高端影像设备等核心领域，出台《优先审批高端医疗器械目录（2025年版）》。深入调研脑机接口医疗器械研发进展，召开专项工作推进会，汇聚产学研医管各方资源，加快产品上市进程。专题调度硼中子俘获治疗系统等“国之重器”研发申报进展。联合推进第二批人工智能医疗器械、生物医用材料创新任务“揭榜挂帅”工作以及2025年高端医疗装备推广应用项目申报工作，加速临床急需、技术领先的高端医疗器械落地应用。　　（三）精准施策有力保障临床需求。在医疗器械创新研发能力较强的11个省份开展“春雨行动”试点，促进以临床价值为导向的医疗器械源头创新和成果转化。发布《免于进行临床评价医疗器械目录（2025年）》《免于进行临床试验体外诊断试剂目录（2025年）》，临床评价要求更加科学精准。全球首发基孔肯雅病毒检测试剂标准物质，加速批准基孔肯雅病毒检测试剂上市。批准7个用于个人自测的甲型/乙型流感病毒抗原检测试剂盒上市，呼吸道疾病检测迈向家庭使用新场景。批准8个罕见病诊断试剂，通过精准识别让有效治疗成为可能。支持粤港澳大湾区、海南自贸港等区域建设，指导特许医疗器械使用，惠及患者。　　（四）持续规范医疗器械注册备案管理。继续开展“进省局、进企业、进医院，促创新、促规范、促提升”的“三进三促”专题调研，选取代表性省份，全面深入“体检”省级注册管理工作。各级监管部门定期发布医疗器械首次注册备案信息，以公开促规范。国家药监局发布3期典型备案事例汇编，指导备案实操。加大各省局医疗器械注册备案数据核查力度，督促提升数据报送质量和效率。发布医疗器械注册审查指导原则99项，公开审评要点35项。梳理汇总各省第二类医疗器械审评要点，共享2024年境内二类首个医疗器械注册审评报告，建立各省交流互鉴机制。持续完善注册管理风险会商机制，国家药监局每季度开展风险会商，对发现的问题及时通过多种方式实现处置闭环。严查注册造假行为，撤销提供虚假资料获取的注册证等。　　（五）纵深推进医疗器械临床试验监管。持续加大临床试验监督抽查力度，国家药监局组织开展两批50个品种的医疗器械临床试验监督抽查，现场检查临床试验机构99家次，各地医疗器械临床试验机构日常监督检查实现两年内全覆盖，以查促规范，不断提升医疗器械临床试验质量。组织编写医疗器械临床试验监督抽查典型案例汇编，加强临床试验检查工作指导。　　（六）加速提升医疗器械审评审批能力。印发《省级医疗器械审评质量管理体系指导意见》，推动全系统审评工作在同一体系下有效开展。组织北京、上海、江苏、浙江、山东、广东开展12期线上、6期线下境内第二类医疗器械审评审批实训，覆盖近7000人次。举办“器审云课堂”44期，新增“器审云课堂”线上中英文培训视频189个，发布共性问题答疑77个。　　（七）持续健全医疗器械标准体系。2025年，审核报送医疗器械国家标准立项109项，审核发布行业标准80项、废止14项。现行有效医疗器械标准共2082项，其中国家标准325项，行业标准1757项。“十四五”规划500项标准制定任务如期完成，标准体系覆盖性、系统性不断提升。筹建全国智能化医疗器械、中医医疗器械标准化工作组，组建医用光辐射安全和激光设备分技术委员会。加快推动医用机器人、高端医学影像设备、人工智能医疗器械、新型生物材料医疗器械、脑机接口医疗器械、中医器械等重点领域国家标准制定，全球首发2项脑机接口医疗器械标准。积极提升标准领域国际话语权，实质性参与国际标准制修订。新增国际标准组织注册专家76名，3项国际标准项目提案获批立项，牵头制修订的国际标准已发布8项、推进中7项。　　（八）稳步推进医疗器械分类管理。2025年公开4批次992个典型产品的分类界定结果。开展《医疗器械分类目录动态调整工作程序》修订工作。发布《国家药监局关于调整〈医疗器械分类目录〉部分内容的公告》。聚焦监管急需，发布二代基因测序相关体外诊断试剂等4个分类界定指导原则，明晰产品注册申报路径。研究建立医疗器械分类命名数据库，完成《医疗器械分类目录》5926个品名举例与医疗器械通用名称的一致性梳理。　　（九）不断提升监管科学化智慧化水平。前瞻性开展脑机接口、人工智能、新型生物材料等医疗器械重点领域10项监管科学项目研究。8家机构成功入围医疗器械领域监管科学创新研究基地，监管科学研究力量进一步增强。组织9省（市）共同推进人工智能辅助第二类医疗器械注册审评创新项目，明确人工智能辅助审评应用场景和开发方案。加强临床试验信息化建设，指导省局临床试验监管信息和项目备案信息填报质量，规范临床试验机构年报要求。有序推进医疗器械唯一标识（UDI）实施，研究明确后续品种UDI实施时间表和特定情形UDI实施要求。　　（十）积极开展国际交流合作。强化双边、深度参与多边合作，扩展多层次、全方位国际合作网络。积极参与IMDRF工作，带领推进GHWP工作，中国医疗器械监管的国际影响力、参与度和领导力得到实质性提升。推动相关国际规则在国内转化实施，积极推进审评技术要求与国际通用技术要求协调，开展世卫组织WLA认可规则和要求研究，积极推进国际监管信赖，助力中国医疗器械“走出去”。　　二、医疗器械注册申请受理情况　　2025年，国家药监局依职责共受理医疗器械首次注册、延续注册和变更注册申请共计14647项，与2024年相比增加5.9%。　　（一）整体情况　　受理境内第三类医疗器械注册申请8766项，受理进口医疗器械注册申请5881项。　　按注册品种区分，医疗器械注册申请11106项，体外诊断试剂注册申请3541项。　　按注册形式区分，首次注册申请3551项，占全部医疗器械注册申请的24.24%；延续注册申请5189项，占全部医疗器械注册申请的35.43%；变更注册申请5907项，占全部医疗器械注册申请的40.33%。注册形式比例情况见图1。　　（二）分项情况　　1.境内第三类医疗器械注册受理情况　　境内第三类医疗器械注册受理共8766项，其中医疗器械注册申请6763项，体外诊断试剂注册申请2003项。　　从注册形式看，首次注册3015项，占全部境内第三类医疗器械注册申请数量的34.4%；延续注册2533项，占全部境内第三类医疗器械注册申请数量的28.9%；变更注册3218项，占全部境内第三类医疗器械注册申请数量的36.7%。注册形式分布情况见图2。　　2.进口第二类医疗器械注册受理情况　　进口第二类医疗器械注册受理共2993项，其中医疗器械注册申请1858项，体外诊断试剂注册申请1135项。　　从注册形式看，首次注册227项，占全部进口第二类医疗器械注册申请数量的7.6%；延续注册1499项，占全部进口第二类医疗器械注册申请数量的50.1%；变更注册1267项，占全部进口第二类医疗器械注册申请数量的42.3%。注册形式分布情况见图3。　　3.进口第三类医疗器械注册受理情况　　进口第三类医疗器械注册受理共2888项，其中医疗器械注册申请2485项，体外诊断试剂注册申请403项。　　从注册形式看，首次注册309项，占全部进口第三类医疗器械注册申请数量的10.7%；延续注册1157项，占全部进口第三类医疗器械注册申请数量的40.1%；变更注册1422项，占全部进口第三类医疗器械注册申请数量的49.2%。注册形式分布情况见图4。　　三、医疗器械注册审批情况　　2025年，国家药监局共批准医疗器械首次注册、延续注册和变更注册14187项，与2024年相比注册批准总数量增长8%。　　其中，首次注册3402项，延续注册5056项，变更注册5729项。　　2025年，企业自行撤回首次注册申请、自行注销注册证书331项。　　近12年国家药监局批准医疗器械注册情况见图5。　　（一）整体情况　　2025年，国家药监局批准境内第三类医疗器械注册8147项，进口医疗器械6040项。　　按照注册品种区分，医疗器械10621项，占全部医疗器械注册数量的74.9%；体外诊断试剂3566项，占全部医疗器械注册数量的25.1%。　　按照注册形式区分，首次注册3402项，占全部医疗器械注册数量的24%；延续注册5056项，占全部医疗器械注册数量的35.6%；变更注册5729项，占全部医疗器械注册数量的40.4%。注册形式比例情况见图6。　　（二）分项情况　　1.境内第三类医疗器械注册审批情况　　境内第三类医疗器械注册8147项。其中，医疗器械6204项，体外诊断试剂1943项。　　从注册形式看，首次注册2760项，占全部境内第三类医疗器械注册数量的33.9%，延续注册2456项，占全部境内第三类医疗器械注册数量的30.1%；变更注册2931项，占全部境内第三类医疗器械注册数量的36.0%。注册形式分布情况见图7。　　2.进口第二类医疗器械注册审批情况　　进口第二类医疗器械3102项。其中，医疗器械注册1907项，体外诊断试剂注册1195项。　　从注册形式看，首次注册270项，占全部进口第二类医疗器械注册数量的8.7%；延续注册1450项，占全部进口第二类医疗器械注册数量的46.7%；变更注册1382项，占全部进口第二类医疗器械注册数量的44.6%。注册形式分布情况见图8。　　3.进口第三类医疗器械注册审批情况　　进口第三类医疗器械注册2938项。其中，医疗器械注册2510项，体外诊断试剂注册428项。　　从注册形式看，首次注册372项，占全部进口第三类医疗器械注册数量的12.7%；延续注册1150项，占全部进口第三类医疗器械注册数量的39.1%；变更注册1416项，占全部进口第三类医疗器械注册数量的48.2%。注册形式分布情况见图9。　　（三）首次注册项目月度审批情况　　2025年，国家药监局首次注册月度审批情况见图10。　　（四）具体批准品种种类分析　　注册的境内第三类医疗器械，除体外诊断试剂外，共涉及《医疗器械分类目录》中18个子目录的产品。　　注册数量前五位的境内第三类医疗器械是：无源植入器械，有源手术器械，神经和心血管手术器械，口腔科器械，医用成像器械。与2024年相比，无源植入器械注册数量同比增加5.1%，有源手术器械超过神经和心血管手术器械，注册数量同比增加34.5%，医用成像器械超过注输、护理和防护器械进入前五位，其他品类注册数量有所下降，如注输、护理和防护器械同比减少31.9%，神经和心血管手术器械同比减少19.9%，口腔科器械同比减少1%。　　注册的进口医疗器械，除体外诊断试剂外，共涉及《医疗器械分类目录》中21个子目录的产品。　　注册数量前五位的进口医疗器械是：口腔科器械，无源植入器械，眼科器械，医用成像器械，有源手术器械。与2024年相比，变化较大，口腔科器械超过无源植入器械，位居第一，注册数量同比增加24%，眼科器械超过有源手术器械，注册数量同比增加35.2%，医用成像器械超过有源植入器械进入前五位，其他品类注册数量略有下降。　　（五）进口医疗器械国别情况　　2025年，共有30个国家（地区）产品在我国获批上市。　　其中，美国、德国、韩国、日本、法国医疗器械在中国医疗器械进口产品首次注册数量位列前5位，注册产品数量约占2025年进口产品首次注册总数量的75.4%。　　从进口医疗器械代理人分布看，共有19个省涉及有本省企业作为进口医疗器械代理人，其中上海市代理人代理的进口首次医疗器械数量最多，占全部进口医疗器械数量的62.1%。　　（六）境内第三类医疗器械省份分析　　从2025年境内第三类医疗器械注册情况看，相关注册人主要集中在沿海经济较发达省份。　　其中，江苏、广东、北京、上海、浙江是境内第三类医疗器械首次注册数量排前五名的省份，占2025年境内第三类医疗器械首次注册数量的65.1%。　　四、创新医疗器械等产品注册审批情况　　2025年，国家药监局按照《创新医疗器械特别审查程序》《医疗器械优先审批程序》继续做好相关产品的审查工作，共收到创新医疗器械特别审批申请457项，其中104项获准进入创新医疗器械特别审查程序；收到优先申请38项，其中26项获准优先审批。　　从2014年至2025年，国家药监局共批准391个创新医疗器械。其中境内创新医疗器械336个，涉及17个省的223家企业；进口创新医疗器械55个，涉及6个国家的30个企业。北京、上海、江苏、广东、浙江创新医疗器械获批产品数量和相应企业数量最多，约占全部已批准的391个创新医疗器械的73.9%。　　已批准的创新医疗器械中，有源产品占比约61%，无源产品约32%，体外诊断试剂产品约7%，具体见图17。　　2025年，国家药监局共批准76个创新医疗器械产品上市，相比2024年增加16.9%。其中有源医疗器械45个，无源医疗器械29个，体外诊断试剂2个。　　有源手术器械、无源植入器械、有源植入器械、眼科器械、神经和心血管手术器械是2025年批准的创新医疗器械数量前五位的品类，与2024年相比，无源植入器械和眼科器械品类的创新产品增长较快。具体见图18。　　这些创新产品核心技术都有我国的发明专利权或者发明专利申请已经国务院专利行政部门公开，产品主要工作原理/作用机理为国内首创，具有显著的临床应用价值。以下是已批准创新医疗器械产品介绍：　　（一）有晶体眼人工晶状体：该产品用于成年人有晶状体眼的治疗，矫正/降低成年人-3.25D-18.00D的近视度数。产品采用零球差大光学区及双凹面型的稳定拱高设计，可提升视觉质量，带来更开阔的周边拱高。　　（二）冷冻消融仪：该产品由主机、同轴流体连接管和连接电缆组成，与该公司生产的球囊型冷冻消融导管配合使用，采用压力流量双控制技术，通过实时监测和控制制冷剂流量与球囊压力，实现球囊在充气和消融过程中的压力稳定。该技术可有效降低球囊在封堵肺静脉和消融过程中因压力波动而产生的弹跳移位风险，用于成人患者药物难治性、复发性、症状性的阵发性房颤治疗。　　（三）人CDO1/AJAP1/GALR1基因甲基化检测试剂盒（荧光PCR法）：该产品由引物、探针、聚合酶等材料组成，对人宫腔脱落细胞样本中基因甲基化状态进行定性检测，用于疑似子宫内膜癌患者的辅助诊断，对子宫内膜癌的防治、提升患者生存率具有重要意义。　　（四）多焦点人工晶状体：该产品为单件式后房人工晶体，由疏水性丙烯酸酯类材料制成，添加紫外吸收剂，可折叠。适用于成人白内障患者无晶体眼的视力矫正，以期待改善近、中、远视力并减少眼镜依赖。　　（五）紫杉醇药物涂层外周球囊导管：该产品为OTW型球囊扩张导管，由远端尖端、球囊、镍钛合金约束结构(CS)、导管轴、应力扩散管、导管座、射线显影环等组件组成。镍钛合金约束结构为球囊外的环状结构，在轴向和径向均分布有约束丝。球囊表面涂覆有紫杉醇，涂层辅料为没食子酸丙酯。产品经环氧乙烷灭菌，一次性使用，货架有效期6个月。该产品用于在股浅动脉、腘动脉原发狭窄病变的经皮腔内血管成形术治疗，病变长度不超过180mm，适用血管直径范围为4-7mm，使用该产品前需经充分预扩张。　　（六）微卫星不稳定性（MSI）检测试剂盒（荧光PCR-毛细管电泳法）：该产品采用了荧光PCR-毛细管电泳法，通过对结直肠癌患者肿瘤组织基因组中的8个微卫星位点定性检测，可实现癌组织样本位点状态的精准判定。该产品主要用于辅助结直肠癌中可能的林奇综合征检测，有利于直肠癌防治、提升患者生存率。　　（七）心脏脉冲电场消融系统和一次性使用磁定位心脏脉冲电场消融导管：心脏脉冲电场消融系统由控制台脚踏开关、连接电缆、电源线等组成，一次性使用磁定位心脏脉冲电场消融导管由环形头端部（含电极）、导管管身、手柄组成。二者联合使用，主要用于治疗药物难治性、复发性、症状性的阵发性房颤。该产品利用脉冲电场的非热效应原理进行房颤治疗，与传统的射频消融及冷冻消融产品相比，可实现对心肌组织的选择性破坏，避免温度传递导致的周围组织损伤风险。　　（八）经导管二尖瓣夹系统：该产品适用于经心脏团队评估后认为存在外科手术高风险，且二尖瓣瓣膜解剖结构适合的退行性二尖瓣反流（MR≥3+）患者。产品采用包裹托举状的闭合形态设计，预期可以实现植入后稳固的锚定；采用锚固件四通道控制通路设计，能够实现瓣叶同时或者分别捕获，预期提高手术成功率，减少手术风险。　　（九）主动脉覆膜支架系统：该产品适用于需要重建左锁骨下动脉血运的Stanford B型夹层患者，其近端锚定区长度应≥15mm。该产品为首款明确适用于烟囱技术的主动脉覆膜支架系统，其主动脉分支支架采用带外层裙边的双层支架结构设计，外层裙边可在支架释放后填补支架与血管形成的间隙，预期可以防止和减少内漏发生，降低并发症风险。　　（十）一次性使用球囊型冷冻消融导管：该产品由球囊型冷冻消融导管和手动回缩器套包组成，与该公司生产的冷冻消融仪配合使用，主要用于成人患者药物难治性、复发性、症状性的阵发性房颤的治疗。一次性使用球囊型冷冻消融导管采用特殊流体喷射装置和球囊内压力监测技术。特殊流体喷射装置可保证球囊前半球表面温度的均匀分布，实现有效消融；球囊内压力监测技术可保证球囊稳定贴靠，实现球囊内部压力稳定。该产品可有效降低消融过程中球囊因压力波动而产生的弹跳移位风险，使更多阵发性房颤的患者受益。　　（十一）经皮肾小球滤过率测量设备：该产品由主机、传感器和固定贴组成，与该公司生产的瑞玛比嗪注射液配合使用，主要用于评估患者肾小球滤过率。该产品采用漫反射校正和背景分离校正的荧光示踪剂无创测量方法，通过皮肤表面获取具有时变光学性质的荧光信号衰减数据，实现对肾小球滤过率的连续测量，具有操作简单、无创、快速、准确和可重复测量等优点，使更多需要肾功能监测的临床诊疗患者受益。　　（十二）心脏脉冲电场消融仪和一次性使用心脏脉冲电场消融导管：心脏脉冲电场消融仪由主机和附件组成，附件包含交流电源线、脚踏开关、心电导联线、等电位线。一次性使用心脏脉冲电场消融导管由电极、电极管、导管管身、手柄、连接器和连接电缆组成。上述两个产品配套使用，利用高电压脉冲产生的电场消融房颤，可使病变细胞发生不可逆的电穿孔而坏死或凋亡。该产品可实现对心肌组织的选择性破坏，避免温度传递导致的周围组织损伤风险，使更多药物难治性、复发性、症状性、阵发性房颤的患者受益。　　（十三）经导管三尖瓣环成形系统：经导管三尖瓣环成形系统包括三尖瓣环夹系统和输送鞘套件，其中三尖瓣环夹系统包括夹合部件、锚钉部件和输送系统，输送鞘套件包括输送鞘和扩张器。该产品用于缓解患者的三尖瓣反流和心衰的临床症状。适用于无需同期行左侧瓣膜手术的孤立性重度三尖瓣反流伴有非严重的瓣环扩张或右心室扩大，有右心衰的临床症状；无严重肺动脉高压，无严重右心室/左心室收缩功能障碍，且经过指南指导药物治疗30天以上药物治疗疗效不佳，经心脏团队评估为不适合外科手术的65岁以上的高危禁忌患者。　　（十四）消化道内窥镜手术器械控制设备和一次性使用消化道内窥镜组织钳：该产品由电控单元、驱动装置、操作手单元组成，与该公司生产的一次性使用消化道内窥镜组织钳配合使用，适用于食管、胃内镜黏膜下剥离术中对病变组织进行钳夹、提拉。该产品为国内首个消化内镜整合型机器人，采用消化内镜外挂柔性机械臂，通过主从控制模式实现末端执行器4自由度运动，精确控制夹取位置与方向，并对有重复夹取需求的组织进行提拉，确保手术视野清晰，降低手术风险。该产品具有设计简洁、操作简便、成本低廉等优势，对推进我国消化道早癌早诊早治，降低全社会消化道癌症医疗负担具有积极意义。　　（十五）外周静脉取栓支架系统：该产品由ClotTriever取栓鞘管和ClotTriever取栓支架组成，取栓鞘管组件包括鞘管、扩张器、预扩张器、装载工具、大口径抽吸注射器。该产品适用于有下述情况的下肢深静脉血栓形成（DVT）的经导管血栓清除治疗：（1）急性期髂股和股腘静脉DVT；（2）亚急性期髂股静脉DVT。　　（十六）冠状动脉介入手术控制系统：该产品由控制机柜、液晶显示器、触摸屏、控制盒、导丝与导管执行机构组成，适用于经皮冠状动脉介入手术期间对导管和导丝的输送与操作。该产品属于支架递送型机器人，采用隔室控制介入机器人手术系统、基于仿生学的导丝控制技术和柔性导丝阻力检测技术。隔室控制介入机器人手术系统采用主从架构设计，具有低延时、高安全操作特点；基于仿生学的导丝控制技术模拟医生手指导丝运动，具有小体积、高精度控制特点；柔性导丝阻力检测技术实时获取动态变化的受力信号，具有高灵敏、高稳定信息传输特点。该产品可有效提高经皮冠状动脉介入手术的操作精度、稳定性和灵活性，使更多患者受益。　　（十七）一次性使用压力监测射频消融导管：该产品由头端、管身、手柄、线缆、盐水接头和光电混合插头组成，与上海宏桐实业有限公司的心脏射频消融仪配合使用，主要用于药物难治性、复发性、症状性的阵发性房颤的治疗。一次性使用压力监测射频消融导管通过内置光学压力传感器，实现临床使用过程中压力的实时监测和反馈，确保消融效果稳定性。该产品可有效降低术中导管与组织贴靠过紧造成蒸汽爆裂或贴靠不足引起消融不完全等风险，使更多阵发性房颤的患者受益。　　（十八）心脏脉冲电场消融设备和一次性使用磁电定位心脏脉冲电场消融导管：心脏脉冲电场消融设备由主机、电源线、脚踏开关、夹式接地线、导管转接盒、串口连接线等组成。一次性使用磁电定位心脏脉冲电场消融导管由心脏脉冲电场消融导管及连接尾线组成，其中导管由环形圈段、可弯段、主体段、取直器、控弯手柄及插座组成。上述两个产品配套使用，利用高电压脉冲产生的电场消融房颤，可使病变细胞发生不可逆的电穿孔而坏死或凋亡。该产品可实现对心肌组织的选择性破坏，避免温度传递导致的周围组织损伤风险，使更多药物难治性、复发性、症状性、阵发性房颤的患者受益。　　（十九）心脏脉冲电场消融仪和一次性使用心脏脉冲电场消融导管：心脏脉冲电场消融仪由主机、脚踏开关及电源线组成。一次性使用心脏脉冲电场消融导管由主体管、放电电极、手柄、延长管和连接插头组成。两个产品配套使用，主要用于治疗药物难治性、复发性、症状性阵发性房颤。心脏脉冲电场消融仪输出高压脉冲信号，经一次性使用心脏脉冲电场消融导管传递至治疗部位，通过输出高压脉冲电场能量，选择性对目标治疗区域心肌组织产生不可逆转的电穿孔损伤，以实现肺静脉电隔离达到对阵发性房颤治疗目的。该产品利用脉冲电场的非热效应原理对房颤进行治疗，与传统射频消融及冷冻消融产品相比，可实现对心肌组织的选择性破坏，有效避免温度传递过程导致的周围组织损伤等风险，使更多药物难治性、复发性、症状性、阵发性房颤的患者受益。　　（二十）经导管主动脉瓣膜系统：该产品适用于经心脏团队评估无法耐受等待常规经导管主动脉瓣膜预装时间的患者，且经心脏团队结合评分系统评估后认为患有症状的、钙化的、重度退行性自体主动脉瓣狭窄，不适合接受常规外科手术置换瓣膜，年龄≥70岁的患者。该产品为预装式、可回收的经导管主动脉瓣膜系统，采用干瓣工艺制成，在提升临床使用便利性的同时，减少了瓣叶长期处于压缩状态导致的瓣叶变形风险。　　（二十一）一体式人工血管术中支架系统：该产品适用于Standford A型主动脉夹层的升主动脉、主动脉弓部置换和降主动脉支架象鼻术，采用一体式远端免缝合固定技术，可缩短远端循环时间，减少可能发生的并发症。　　（二十二）可降解耳鼻止血绵：该产品为多聚醚型聚氨酯海绵，由（DL-丙交酯-co-ε-己内酯）-氨酯共聚物组成，具有多孔层状结构，对液体有一定的吸收容量，适用于鼻腔、中耳与外耳术后的暂时压迫止血与支撑。　　（二十三）血流导向密网支架：该产品适用于成人患者颈内动脉（岩骨段至末端）与椎动脉未破裂的囊状宽颈（瘤颈≥4mm或瘤体/瘤颈比

WARNING LETTERMedisourceRxMARCS-CMS 717970 —December 12, 2025Delivery Method:VIA Electronic MailProduct:DrugsRecipient:Daniel D. HernandezDirector of QualityMedisourceRx10525 Humbolt StreetLos Alamitos,CA90720-5401United StatesIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERWL # 717970December 12, 2025Dear Mr. Hernandez:You registered your facility with the U.S. Food and Drug Administration (FDA) as an outsourcing facility under section 503B of the Federal Food, Drug, and Cosmetic Act (FDCA) [21 U.S.C. § 353b]1on February 14, 2017, and most recently on December 31, 2024. From May 27, 2025, to June 10, 2025, FDA investigators inspected your facility, MedisourceRx, located at 10525 Humbolt Street, Los Alamitos, CA 90720. During the inspection, the investigators noted that drug products you produced failed to meet the conditions of section 503B of the FDCA necessary for drugs produced by an outsourcing facility to qualify for exemptions from certain provisions of the FDCA.FDA issued a Form FDA 483 to your facility on June 10, 2024. FDA acknowledges receipt of your facility’s responses, submitted on July 2, 2025, September 5, 2025, and October 10, 2025. Based on this inspection, it appears you produced drugs that violate the FDCA.A. Compounded Drug Products under the FDCAUnder section 503B(b) of the FDCA, a compounder can register as an outsourcing facility with FDA. Drug products compounded by or under the direct supervision of a licensed pharmacist in an outsourcing facility qualify for exemptions from the drug approval requirements in section 505 of the FDCA [21 U.S.C. § 355(a)], the requirement in section 502(f)(1) of the FDCA [21 U.S.C. § 352(f)(1)] that labeling bear adequate directions for use and the Drug Supply Chain Security Act requirements in section 582 of the FDCA [21 U.S.C. § 360eee-1] if the conditions in section 503B of the FDCA are met.2An outsourcing facility, which is defined in section 503B(d)(4) of the FDCA [21 U.S.C. § 353b(d)(4)], is a facility at one geographic location or address that — (i) is engaged in the compounding of sterile drugs; (ii) has elected to register as an outsourcing facility; and (iii) complies with all of the requirements of this section. Outsourcing facilities must comply with other applicable provisions of the FDCA, including section 501(a)(2)(B) [21 U.S.C. § 351(a)(2)(B)], regarding current good manufacturing practice (CGMP), and section 501(a)(2)(A) [21 U.S.C. § 351(a)(2)(A)], regarding insanitary conditions. Generally, CGMP requirements for the preparation of drug products are established in Title 21 of the Code of Federal Regulations (CFR) parts 210 and 211.For a compounded drug product to qualify for the exemptions under section 503B, it must be compounded in an outsourcing facility that is in compliance with the registration and reporting requirements in section 503B(b), including the requirement to submit adverse event reports to FDA “in accordance with the content and format requirements established through guidance or regulation under section 310.305 of title 21, Code of Federal Regulations (or any successor regulations)” (section 503B(a)(1), (b)(5) of the FDCA [21 U.S.C. § 353b(a)(1), (b)(5)]).B. Failure to Meet the Conditions of Section 503BDuring the inspection, the FDA investigators noted that drug products produced by your facility failed to meet the conditions of section 503B. For example, the investigators noted that your facility did not submit adverse event reports to FDA in accordance with the content and format requirements established through guidance or regulation under section 310.305 of title 21, Code of Federal Regulations (or any successor regulations).3Specifically,1. You failed to submit the adverse event report identified in Complaint Log # C25004.2. Your documented procedures for reporting adverse events do not adequately define what constitutes a “serious” adverse event (21 CFR 310.305(b)).Because your compounded drug products have not met all of the conditions of section 503B, they are not eligible for the exemptions in that section from the FDA approval requirements of section 505, the requirement under section 502(f)(1) that labeling bear adequate directions for use, and the Drug Supply Chain Security Act requirements described in section 582 of the FDCA.Specific violations are described below.C. Violations of the FDCAUnapproved New Drug ProductsYou do not have any FDA-approved applications on file for drug products that you compound.4Under sections 505(a) and 301(d) of the FDCA [21 U.S.C. §§ 331(d)] a new drug may not be introduced into or delivered for introduction into interstate commerce unless an application approved by FDA under section 505 of the FDCA is in effect for the drug. Marketing of these products, or other applicable products, without an approved application violates these provisions of the FDCA.Misbranded Drug ProductsYou compound drug products that are intended for conditions not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layman can use these products safely for their intended uses. Consequently, their labeling fails to bear adequate directions for their intended uses causing them to be misbranded under section 502(f)(1) of the FDCA.5The introduction or delivery for introduction into interstate commerce of these products therefore violates section 301(a) of the FDCA. Further, it is also a prohibited act under section 301(k) of the FDCA to do any act with respect to a drug, if such act is done while the drug is held for sale after shipment in interstate commerce and results in the drug being misbranded.Failure to Report Adverse EventsAs noted above, your facility failed to submit an adverse event report (section 503B(b)(5) of the FDCA). The failure to report adverse events by an entity that is registered with FDA in accordance with section 503B(b) is a prohibited act under section 301(ccc)(3) of the FDCA [21 U.S.C. § 331(ccc)(3)].D. Corrective ActionsWe have reviewed your facility’s responses to the Form FDA 483.Some of your corrective actions appear adequate: Your firm retroactively submitted reports of serious, unexpected adverse event reports received prior to FDA’s inspection.Some of your corrective actions appear deficient: Submitted documented procedures for reporting adverse events do not appear to adequately address the submission of adverse event reports to FDA in accordance with 21 CFR 310.305. For example, the procedures do not clearly define a “serious” adverse event in a manner consistent 21 CFR 310.305(b).Should you continue to compound and distribute drug products that do not meet the conditions of section 503B, the compounding and distribution of your drugs would be subject to the new drug approval requirement, the requirement to label drug products with adequate directions for use, and the Drug Supply Chain Security Act requirements.E. ConclusionThe violations cited in this letter are not intended to be an all-inclusive statement of violations 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. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.You should take prompt action to address any violations. Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to address any violations. Please include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. This letter notifies you of our concerns and provides you an opportunity to address them. If you believe your products are not in violation of the FDCA, include your reasoning and any supporting information for our consideration. If you cannot completely address this matter within fifteen (15) working days, state the reason for the delay and the time within which you will do so.All correspondence should refer to the Warning Letter Number above (# 717970) and include a subject line that clearly identifies the submission as a Response to Warning Letter. If you have questions regarding the contents of this letter, please contact compoundinginspections@fda.hhs.gov.Sincerely,/S/F. Gail Bormel, JD, RPhDirectorOffice of Compounding Quality and ComplianceOffice of ComplianceCenter for Drug Evaluation and Research_____________________1SeePub. L. No. 113-54, § 102(a), 127 Stat. 587, 587-588 (2013).2We remind you that there are conditions, other than those discussed in this letter, that must be satisfied to qualify for the exemptions in section 503B of the FDCA.3For more information, see, FDA’s guidance, “Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act,” which can be found at https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM434188.pdf.4The specific products made by your firm are drugs within the meaning of section 201(g) of the FDCA [21 U.S.C. § 321(g)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases and/or because they are intended to affect the structure or any function of the body. Further, they are “new drugs” within the meaning of section 201(p) of the FDCA [21 U.S.C. § 321(p)] because they are not generally recognized as safe and effective for their labeled uses.5Your compounded drug products are not exempted from the requirements of section 502(f)(1) of the FDCA by regulations issued by the FDA (see, e.g., 21 CFR 201.115).

WARNING LETTERA. Nelson & Co. Ltd.MARCS-CMS 720283 —February 12, 2026Delivery Method:VIA UPSReference #:320-26-46Product:DrugsRecipient:Michael LockettChief Executive OfficerA. Nelson & Co. Ltd.83 ParksideLondonSW19 5LPUnited KingdomIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesUnited StatesWarning Letter320-26-46February 12, 2026Dear Mr. Lockett:The United States Food and Drug Administration (FDA) conducted an unannounced inspection of your drug manufacturing facility, A. Nelson & Co., Ltd., FEI 1000568184, at 5 Endeavour Way, London, from September 15 to 19, 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 October 9, 2025, 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 conduct, for each batch of drug product, appropriate laboratory testing, as necessary, required to be free of objectionable microorganisms (21 CFR 211.165(b)).You manufacture homeopathic drug products including those labeled for children as young as two years old.You released drug products, including(b)(4)ml (batch(b)(4)) and(b)(4)(batch(b)(4)) without adequate testing for critical microbial attributes (e.g., total microbial count, absence of objectionable microorganisms).Rather than testing every batch, you conducted(b)(4)tests on some of your batches of homeopathic drug products. Moreover, you did not conduct microbial testing before release for your(b)(4)drug products.Furthermore, you extended expiration dates for(b)(4)drug product without adequate stability data to support these changes. For example, you extended the shelf life of(b)(4)ml (batch(b)(4)) from(b)(4), despite your stability data only supporting a(b)(4)month shelf life. Similar practices were also observed with other products.In your response, you state that you implemented microbial testing for each bulk batch of(b)(4)drug products, each finished batch of(b)(4)drug products before release to the U.S., and the bulk(b)(4)component used in your drug products. You also commit to preparing a risk assessment to determine your microbial testing strategy covering all U.S. marketed products as well as a retrospective evaluation of all(b)(4)drug products shipped to the U.S. since September 2022 and September 2023, respectively.We also acknowledge that you will reject the(b)(4)ml (batch(b)(4)). However, your response is inadequate because you did not commit to testing your retain samples for drug products that you released without adequate microbial testing.Of particular note, your drug product(b)(4)(batch(b)(4)) was detained and refused admission at the U.S. border because FDA testing found microbiological contamination.Without testing each batch prior to release, you did not have scientific evidence that all(b)(4)drug product batches were free of objectionable microbial contamination.In response to this letter, provide:A list of chemical and microbial specifications, including test methods, used to analyze each batch of your drug products before a batch 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 establish adequate written responsibilities and procedures applicable to the quality control unit and to follow written procedures applicable to the quality control unit (21 CFR 211.22(d)).Your quality unit (QU) failed to provide adequate oversight and to ensure the reliability of data related to the quality of finished drug products manufactured at your facility. For example, you inadequately retained and disposed of CGMP documentation including manufacturing records printed and signed by your QU as well as finished product specifications forms. Notably, a handwritten sticky note indicating an “out-of-trend” result with a quality determination was discovered among the discarded materials, yet this deviation was neither properly documented at the time of performance nor adequately investigated.You printed duplicate copies of records without an adequate procedure for the QU to track the issuance and reconciliation of CGMP documents. Furthermore, numerous analytical forms with unacceptable results were discarded that should have triggered investigations. These deficiencies raise significant data integrity concerns as critical quality records were improperly discarded.In your response, you state that you completed the data integrity investigation with appropriate corrective action and preventive action (CAPA). You also state that following implementation of your CAPA, you will engage an external quality consultant to perform a site data integrity audit to review processes and compliance.Your response did not commit to implementing adequate resources for the QU for tracking the issuance and reconciliation for CGMP documentation. Additionally, your external site data integrity audit is not scheduled until May 2026, which is an excessive delay given the extent of the data integrity violations observed. Further, your consultant engagement is intended as an audit of your corrections rather than a gap analysis providing guidance for adequate remediation. The delay in independent verification, combined with your corrective actions proceeding for eight months without external oversight, fails to provide adequate assurance that the systemic data integrity deficiencies will be adequately addressed in a timely manner.Data integrity is critical throughout the CGMP data life cycle, including in the creation, modification, processing, maintenance, archival, retrieval, transmission, and disposition of data after the record retention period ends.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/media/71023/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, strength, quality, and purity of all products.Data Integrity RemediationYour quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture. See FDA’s guidance documentData Integrity and Compliance With Drug CGMP: Questions and Answersfor guidance on establishing and following CGMP compliant data integrity practices at https://www.fda.gov/media/119267/download.We acknowledge that you are using an independent third-party consultant to audit your operation and assist in meeting FDA requirements. In response to this letter, provide:A comprehensive investigation into the extent of the inaccuracies in data records and reporting including results of the data review for drugs distributed to the United States. Include a detailed description of the scope and root causes of your data integrity lapses.A current risk assessment of the potential effects of the observed failures on the quality of your drugs. Your assessment should include analyses of the risks to patients caused by the release of drugs affected by a lapse of data integrity and analyses of the risks posed by ongoing operations.A management strategy for your firm that includes the details of your global corrective action and preventive action plan. The detailed corrective action plan should describe how you intend to ensure the reliability and completeness of all data generated by your firm including microbiological and analytical data, manufacturing records, and all data submitted to FDA.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. 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 CAPAs 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.Additional API CGMP GuidanceYou manufacture homeopathic active pharmaceutical ingredients (API, also known as(b)(4)) that you use in your finished drug products.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/media/71518/download.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 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 A. Nelson & Co., Ltd., FEI 1000568184, at 5 Endeavour Way, London, 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 1000568184 and ATTN: Michael Klapal.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and Research

WARNING LETTERAQ USA Inc., d.b.a Ross Healthcare Inc.MARCS-CMS 719517 —February 12, 2026Delivery Method:VIA UPSReference #:320-26-45Product:DrugsRecipient:Mr. Marc N. RossQuality Manager/Co-OwnerAQ USA Inc., d.b.a Ross Healthcare Inc.210 S Duffner Dr., Suite ALynden,WA98264United StatesIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter320-26-45February 12, 2026Dear Mr. Ross:The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, AQ USA Inc., d.b.a Ross Healthcare Inc., FEI 3015167023, at 210 S Duffner Dr., Suite A, Lynden, from July 30 to August 12, 2025. We note that Ross Healthcare Inc. (FEI #3010166452) operates a manufacturing facility in Delta, B.C., Canada that was placed on Import Alert 66-40 on November 30, 2017, due to significant CGMP violations. Evidence obtained during the inspection demonstrates that you are manufacturing the same product line at your Lynden, Washington facility that was previously produced at the Canadian facility.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 21, 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 conduct, for each batch of drug product, appropriate laboratory testing, as necessary, required to be free of objectionable microorganisms. Your firm also failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity ((21 CFR 211.165(b) & 21 CFR 211.160(b)).Your firm manufactures drug products such as(b)(4), intended for(b)(4). You failed to conduct adequate finished product testing for each batch of your drug product. For example, you released your finished drug product(b)(4)without testing for critical microbial attributes (e.g., total count, absence of objectionable microorganisms).Furthermore, you failed to establish scientifically sound and adequate specifications for microbial limits for your drug products. For example, we reviewed your established microbiological limits for total aerobic plate count and note that they are set(b)(4)times greater than the United States Pharmacopeia (USP) Microbiological Examination Of Nonsterile Products: Microbial Enumeration Testslimit of 10² cfu.In your response, you state that you will conduct the microbial rapid test system validation accordance with USP Validation of Alternative Microbiological Methodsrequirements and the manufacturer’s specifications. You also note that you will verify system suitability for the specific product type and that you will maintain comprehensive raw data documentation for all tested batches.Your response is inadequate because it lacks sufficient detail regarding tests for each finished drug batch and fails to include a risk assessment or retrospective review of products released without appropriate testing.Adequate microbial specifications and testing methods to detect objectionable microorganisms in the presence of each drug product must be established. Without testing each batch prior to release, you did not have scientific evidence that all(b)(4)drug product batches were free of objectionable microbial contamination.In response to this letter, provide:A list of chemical and microbial specifications including test methods used to analyze each batch of your drug products before a batch 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.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.2. Your firm failed to establish and follow written procedures describing in sufficient detail the receipt, identification, storage, handling, sampling, testing, and approval or rejection of components and drug product containers and closures (21 CFR 211.80(a)).Your firm approved “(b)(4)” for use as a component in your drug products. For example, “(b)(4)” is approximately(b)(4)% of your(b)(4)drug product. At a minimum, you must use(b)(4)(refer to USP(b)(4)) to manufacture your non-sterile drug products.(b)(4)must be suitable for its intended use and routinely tested to ensure ongoing conformance with appropriate chemical and microbiological attributes.In your response, you indicate that you will discontinue the use of “(b)(4)” and procure and use only(b)(4)that meets USP(b)(4)specifications. You also state that you will initiate contract testing of your current(b)(4)supply for microbiological and chemical quality. Your response is inadequate because you failed to address drug products currently on the market that were manufactured using “(b)(4)”.In response to this letter, provide:A comprehensive, independent review of your material system including, but not limited to:o Evaluating all suppliers of materials (components, containers, and closures) to determine if they are reliable and appropriately qualified.o An assessment of all materials to determine whether they are consistently of acceptable quality.o A review to ensure assigned expiration or retest dates are appropriate (supported by data).o Adequacy of the supplier qualification program, and its selection, qualification, and disqualification provisions.o Based on a thorough review, provide a summary of your systemic corrective action and preventive action (CAPA) plan to remediate the vendor qualification program and prevent use of unsuitable components, containers, and closures.A detailed risk assessment for drug products currently in U.S. distribution, or within expiry, manufactured using inappropriate(b)(4). Specify actions that you will take in response to the risk assessment, such as customer notifications and product recalls.A procedure for your(b)(4)monitoring that specifies routine microbial testing of(b)(4)to ensure its acceptability for use in each batch of drug products produced by your firm.The microbiological quality control specifications you use to test and release each incoming lot of component for use in manufacturing.A summary of results from testing retain samples of all drug product batches within expiry. You should test microbiological quality (total counts and identification of bioburden to detect any objectionable microbes) of each batch. If testing yields an out-of-specification (OOS) result, indicate the corrective actions you will take, including notifying customers and initiating recalls.3. Your firm failed to conduct at least one test to verify the identity of each component of a drug product. 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)).Your firm failed to test incoming raw materials including active pharmaceutical ingredients (e.g.,(b)(4)) used to manufacture your drug products to determine their identity, purity, strength, and other appropriate quality attributes. You released(b)(4)USP lots into production without performing adequate acceptance testing, including identity. In addition, you relied on your suppliers’ certificate of analysis (COA) without establishing the reliability of each of your component suppliers’ test analyses at appropriate intervals.In your response, you state that you will immediately withhold all incoming lots of(b)(4)USP and other raw ingredients pending sampling, testing, and approval by the quality control unit. Your response is inadequate because you do not provide details to demonstrate that your components meet all compendial requirements (e.g., specific tests to be performed). Additionally, you do not propose testing retain samples or otherwise conducting an analysis of previously used(b)(4)USP lots as well as other drug product components to ensure that all quality attributes are met.Without adequate testing, you do not have scientific evidence that the components conform to appropriate specifications before their use in the manufacture of your drug products. You are responsible for sampling, testing, and examining drug components before use in production to ensure that acceptable quality parameters are met.In response to this letter, provide:The chemical and microbiological quality control specifications you use to test and release each incoming lot of components for use in manufacturing.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 re-validation. In addition, include a commitment to always conduct at least one specific identity test for each incoming component lot.A summary of results obtained from testing all components to evaluate the reliability of the COA from each component manufacturer. Include your SOP that describes this COA validation program.A summary of your program for qualifying and overseeing contract facilities that test the drug products you manufacture.4. Your firm failed to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products and to use results of stability testing to determine appropriate storage conditions and expiration dates (21 CFR 211.166(a)).Your firm does not have adequate stability testing data to demonstrate that the microbiological properties of your drug products meet established specifications and that they remain acceptable for the duration of their labeled shelf lives of(b)(4). During the inspection you were unable to provide raw data for any microbiological testing conducted. In addition, your firm lacked adequate stability chambers to ensure appropriate storage conditions (e.g., temperature and humidity) for your stability samples.In your response you state that you will draft written testing program protocols to identify all marketed products for immediate stability testing, retrieve representative samples for testing initiation, and assign interim expiry dates pending preliminary data generation.Your response is inadequate because it fails to include sufficient details on your stability program, including how you will ensure adequate sampling and appropriate specifications. Additionally, it does not include a retrospective risk assessment for your distributed drug products that are currently on the U.S. market and within expiry. 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 your 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.5. 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)You lacked adequate quality unit (QU) oversight for the manufacture of your drug products. For example, your QU failed to ensure the following:Establishment of adequate production procedures and process control to assure your drug products have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(a)).Establishment of adequate batch production and control records that contain the accomplishment of each significant step in the manufacture, processing, packing, or holding of the batch, for each batch of drug product (21 CFR 211.188(b)).Validation of test methods to verify their accuracy, sensitivity, specificity, and reproducibility (21 CFR 211.165(e)).In your response, you commit to drafting and approving procedures and retraining personnel. Additionally, you commit to performing process validation, updating batch records, and validating test methods.Your response is inadequate because you do not address how you plan to ensure that your quality unit has sufficient resources to carry out its responsibilities and consistently ensure drug quality.You did not provide details about how you will conduct process validation. Furthermore, you did not provide revised batch production records. Complete and accurate batch production and control records are necessary to ensure that manufacturing processes are consistently followed and reproducible. In addition, you did not provide sufficient evidence to demonstrate in-house methods are equivalent or superior to the USP methods.Significant findings in this letter demonstrate that your firm does not operate an effective quality system in accordance with CGMP. 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/media/71023/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 appropriateo Provisions for QU oversight throughout your operations to evaluate adherence to appropriate practiceso A complete and final review of each batch and its related information before the QU disposition decisiono Oversight 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.A timeline for performing process validation 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 comprehensive independent assessment of your laboratory practices, procedures, and methods. Based on this review, provide a detailed plan to remediate and evaluate the effectiveness of your laboratory system.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 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 3015167023 and ATTN: Niketa Patel.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and Research