江西省方竹药业有限公司：根据江西省方竹药业有限公司申请，我局依据《中华人民共和国药品管理法》《药品生产监督管理办法》有关规定，经现场检查和综合评定，认为本次检查符合《药品生产质量管理规范（2010年修订）》及相关附录的要求。检查具体信息如下：企业名称生产地址检查范围检查日期检查结论江西省方竹药业有限公司生产地址1：江西省新余市高新开发区光电产业院内6010号生产地址2：江西省新余市高新开发区赛维大道3168号生产地址：江西省新余市高新开发区赛维大道3168号；生产范围：中药饮片（含直接口服饮片：酒制蜂胶，直接口服饮片；净制、切制、炮炙（炒制、炙制、制炭、蒸制、煮制）、其他（燀制、制霜、发酵、炆制））***2026年4月1日-4月3日本次检查符合药品GMP及相关附录的要求。 江西省药品监督管理局2026年5月12日

近日，省药监局深入开展树立和践行正确政绩观，推动学习教育走深走实、见行见效，坚持“服务基层”与“赋能产业”双向发力，相继制定印发《第一类医疗器械备案管理指导手册》和《第二类医疗器械注册管理实施意见》。通过“送工具”夯实基层基础、“建机制”深化注册管理，双管齐下构建医疗器械注册备案管理新格局，进一步推进全省医疗器械监管科学化、规范化。一是送工具书下基层，筑牢一类备案“基准线”。坚持监管与服务并重，针对基层监管人员特别是新入职人员业务不熟、实操困难、查阅不便等痛点，以及在实际工作中的“上手难、查询繁”等问题，省药监局主动靠前、精准服务，编制印发《指导手册》，突破传统单一“文件汇编”模式，采用“操作指引+法规汇编”合订本，系统梳理备案主体资格、资料审核标准及省内4类高频产品审核要点，并配套一类医疗器械违法典型案例，为基层监管人员提供一本“看得懂、用得上、查得快”的案头工具书和业务入门指南，切实提升基层履职效能与备案监管质量。二是聚焦痛点精准施策，跑出二类注册“加速度”。针对省内产品同质化、低水平重复申报、内卷式竞争等问题，为引导产业健康高质量发展，省药监局聚焦产品命名规范、预期用途审核、同品种比对等关键环节，统一审评尺度，严控审评标准，通过实施“春雨行动”优先审评、“四方联动会”及深化线上办理等九方面20项具体举措，进一步提升审评审批质效，全力支持适合高原医学特色创新产品加快上市，从源头提升我省产品竞争力。三是强化协同联动，构建审管衔接“一盘棋”。坚持注册备案统筹推进、审批监管闭环衔接。强化《指导手册》落地运用与日常监管深度融合，健全与市州市场监管局动态跟踪与风险会商机制，坚决防范高风险产品高类低备，严防“非医疗器械按医疗器械备案”；推动第二类医疗器械在注册受理、审评、核查、审批全流程、各环节高效衔接、一体联动，强化上市后质量监管、不良事件监测、检验抽检、日常监管等信息应用，以全链闭环管理持续优化注册管理，提升监管效能。同步制定回顾性审查方案，对已上市产品开展“回头看”，切实筑牢医疗器械质量安全底线。下一步，省药监局将持续深化正确政绩观学习践行，坚守医疗器械监管初心，勇担安全监管使命，以更加务实作风、更高标准、更优服务守护人民群众用械安全。以高效规范监管助力全省医疗器械产业高质量发展贡献药监力量。

永丰县医保局坚持党建引领，近日联合卫生健康、市场监管等部门协同发力，以“十统一”为核心抓手，全力构建全域联动、规范高效、便民惠民的药耗集中采购新体系，推动全县医药卫生全面深化改革走深走实。该县召开专题部署会议，压紧压实工作责任，明确推进路径与落实时限，推动医共体药耗采购由“分散管理”向“集中统筹”转变。以医共体总医院为唯一采购主体，整合优化全省招采子系统账号权限，统一使用主账号开展采购业务，成员单位账号由主账号统一分配管理，彻底告别过去多头采购、账号分散、管理粗放的旧模式，为改革高效落地筑牢基础。围绕“十统一”核心要求，该县聚焦关键环节精准发力。医共体总医院牵头成立药事管理与药物治疗学委员会，优化更新统一药耗目录；统筹归集各成员单位采购需求，以医共体为整体集中报量、统一议价、统一签订三方协议；规范配送、验收、入库流程，实现账、货、单精准一致；建立内部调剂机制，让紧缺药品、急抢救药品、近效期药品在医共体内高效流转、充分利用；同步推进统一追溯、统一结算、统一考核、统一信息，构建全链条闭环管理新模式。如今，该县已实现账号、目录、需求、采购、配送、追溯、调剂等多项统一落地运行，医共体总医院成功发出首笔联合采购订单，标志着药耗统一采购进入实质化运行阶段。目前，全县已完成药品采购738种，金额达648.41万元；医用耗材采购424种，金额达289.73万元。

各有关单位：按照化妆品标准化工作安排，国家药监局印发了《2026年化妆品标准立项计划》。现公开征集2026年标准制修订项目起草单位，请有意向的单位在化妆品标准制修订管理系统（网址为https://www.nifdc.org.cn/nifdc/bshff/hzhpbzh/hzhpbzhxt/index.html）按要求提交相关资料。征集截止时间为2026年6月15日。此外，为提高化妆品标准制修订工作的质量和效率，本年度同步增设了化妆品标准制修订调研立项计划，旨在为后续相关标准的制修订提供立项依据、背景资料和研究基础等。调研项目起草单位的遴选流程、要求等与标准制修订项目一致。联系人：卢老师（化妆品安全技术评价中心，010-67095881）孔工（系统工程师，18723754957）中检院2026年5月13日

2025年，药品注册申请申报量持续增长，药审中心受理各类注册申请20149件(同比增加3.00%，以受理号计，下同)，包括药品制剂注册申请18448件(同比增加5.56%),化学原料药注册申请1701件。18448件药品制剂注册申请包括技术审评类注册申请16130件(同比增加5.30%)，直接行政审批类注册申请2318件(包括补充申请和一次性进口)。2021年至2025年注册申请受理情况详见图1。详细见附件：2025年度药品审评报告

省药监局药品生产处、各检查分局，有关企业：为进一步加强药品委托生产监管，全面掌握我省辖区内药品委托及受托生产基本情况，四川省药监局依托四川省药品监督管理局企业服务平台建立并开通了“委托与受托信息登记平台”企业报送端口，现决定试行启用。现将有关事宜通知如下。一、平台主要功能平台主要用于药品上市许可持有人与药品受托生产企业委托生产信息填报、变更维护、委托品种、委托生产监管及抽检信息等管理。企业通过平台完成信息登记后，相关数据将作为日常监管、监督检查及追溯管理的重要依据。二、试行范围凡涉及药品委托生产业务（含已获批的委托生产及正在申请/变更中的委托生产情形）的下列单位，均须纳入平台管理：（一）药品上市许可持有人；（二）受托生产的药品生产企业。三、试行时间安排平台开放时间：自本通知印发之日起开放企业端登录与数据填报功能。信息完善时限：各相关企业应于2026年5月20日前完成首次委托生产历史数据及在产委托品种信息的填报与核验。后续维护要求：自2026 年5月20日起，凡委托生产新增、变更或终止的，企业均应自相关事项获批或调整之日起 15 个工作日内完成平台信息维护。其他监管信息应分别在每年6月30日及12月30日前各更新完善一次。四、登录及操作方式（一）平台网址：http://103.203.217.49:8188（二）登录方式：通过四川省药品监督管理局企业服务平台企业端进行登陆报送。（三）操作指南：请各相关企业通过登陆链接查看填报操作指南。https://file.scypjg.cn:4432/zhsq/0download%2F 委托受托流程.pdf五、工作要求（一）按时完成填报。请各相关监管单位督促辖区内相关企业严格按照通知要求按时完成信息首次填报和后续更新维护。（二）落实专人负责。企业应指定专人负责平台维护工作，确保信息更新及时。（三）确保数据准确。各相关企业应对填报信息的真实性、准确性、完整性负责，平台信息应与实际生产、许可及监管档案保持一致。（四）加强信息利用。平台信息将作为日常监管、延伸检查和监督抽检的重要参考，请各监管单位做好相关信息审核统计和信息数据应用工作。监管端登陆账号由省局药品生产处另行通知。六、技术咨询与支持试行期间，如遇平台技术操作问题，可联系技术支持热线：028-86783506（工作日 8∶30-17∶30），联系人：杨老师。请各企业高度重视，按时完成信息填报及维护工作，确保药品委托生产管理规范、信息可溯。特此通知。 四川省药品监督管理局办公室2026 年 5 月 12 日

各有关单位：   为进一步规范行政决策行为，优化药品监管政策供给，我局拟制了《海南省药品监督管理局关于加强基本药物质量监督管理的规定（征求意见稿）》，现公开征求意见，请于2026年6月12日前将修改意见反馈至yj_scz@hainan.gov.cn。在邮件主题请注明“关于加强基本药物质量监督管理的规定建议反馈”。    附件：《海南省药品监督管理局关于加强基本药物质量监督管理的规定（征求意见稿）》 海南省药品监督管理局2026年5月12日 附件：海南省药品监督管理局关于加强基本药物质量监督管理的规定（征求意见稿）一、总 则第一条　为加强海南省基本药物质量监督管理，保证全省生产、经营的基本药物质量，依据《中华人民共和国药品管理法》、国家药品监督管理局《关于加强基本药物质量监督管理的规定》等法规文件，制定本规定。第二条 本规定所称基本药物品种是指政府管理部门根据“防治必需、安全有效、价格合理、使用方便、中西并重、基本保障、临床首选和基层能够配备”原则制定的国家基本药物目录中的品种。第三条 本规定所称基本药物生产企业和配送企业是指在省级人民政府指定的机构组织的基本药物生产、配送公开招标采购中中标的药品上市许可持有人和经营企业。第四条　省药品监督管理局负责组织实施、指导协调全省基本药物质量监督管理工作，负责具体实施辖区内基本药物生产质量监督管理工作，指导市县市场监督管理局实施配送和使用环节的质量监督管理工作。第五条　市县市场监督管理局应当按照职责分工和属地管理的原则，各负其责，利用现有资源，充分发挥农村药品监督网在保证基本药物质量监督管理中的作用，加强对城市社区和农村基本药物质量监督管理。第六条 基本药物生产企业应当大力推动技术进步，提高药品质量，减少药品不良反应。二、生产监管第七条 省药品监督管理局要做好基本药物注册和已获批准文号药品生产前的现场核查，确保基本药物按批准的处方工艺生产。第八条　基本药物生产企业应当针对基本药物生产规模大、批次多的特点，对处方工艺进行自查，严格按照《药品生产质量管理规范》组织生产。第九条　省药品监督管理局负责组织对基本药物生产企业进行处方和工艺核查，对核查结果不符合要求的，企业不得组织生产。第十条 基本药物生产企业应建立并实施质量受权人制度，加强对原辅料采购、投料、工艺控制及验证、产品检验、放行等环节的管理，确保质量保证体系的有效运行，确保药品质量。第十一条　省药品监督管理局要加强对基本药物生产企业的监督检查，结合年度检查工作计划重点核查基本药物品种。对检查中发现的问题，及时督促企业整改。对存在违法行为的，依法予以查处，并将查处结果通报省基本药物招标采购机构。第十二条 省药品监督管理局负责建立基本药物生产企业品种档案和监管档案，为全省基本药物生产管理提供依据。三、 流通、使用监管第十三条鼓励和推动基本药物配送企业，尤其是具有药品现代物流条件的药品批发企业兼并重组、整合配送资源，提高全省药品配送能力。第十四条 基本药物的配送企业必须严格按照《药品经营质量管理规范》的要求，落实质量管理措施，加强对基本药物进货、验收、储存、出库、运输等环节的管理。配送企业购销基本药物，必须严格按照《合同法》的规定，签订销售合同并明确质量条款，质量条款的内容应符合《药品经营质量管理规范》的有关要求。配送企业购销基本药物，必须索要和开具《增值税专用发票》或《增值税普通发票》（简称税票）。所销售药品还应附销售出库单，税票与销售出库单的相关内容应对应，金额应相符。对票、货之间内容不相符的，不得验收入库。配送企业购进基本药物不得委托验收，直调药品验收员每年必须接受省药品监督管理局组织的继续教育。配送企业必须根据药品包装及道路、天气状况等采取相应措施。对农村、偏远地区的药品配送，要防止运输过程中不良因素对药品质量造成影响。第十五条　省药品监督管理局加强对基本药物配送企业的监督管理，适时组织对配送企业进行监督检查，对配送企业的质量管理进行评价，定时将评价结果上网公示；依法严厉查处违法违规行为，将查处结果通报本省基本药物招标采购机构。省药品监督管理局结合《药品经营许可证》监督检查和药品经营质量管理规范跟踪检查、日常抽查、专项检查等，每年至少对配送企业组织一次监督检查。第十六条　零售药店必须严格按照《药品经营质量管理规范》的要求，加强基本药物管理，重点规范进货、验收、储存、调配等环节，保证基本药物质量。零售药店购进基本药物，必须验明税票、供货方销售出库单与实际购进药品的品名、规格、批号和数量，核对一致后方可作为合格药品入库或上架销售。零售药店必须按规定配备执业药师或其他依法经资格认定的药学技术人员为患者提供基本药物购药咨询和用药指导。零售药店销售基本药物，必须准确无误，并正确说明用法、用量和注意事项；调配处方必须经过核对，对处方所列药品不得擅自更改或者代用；对处方的合法性与合理性进行审核。第十七条　市县市场监督管理局应当加强对零售药店基本药物质量的监督管理，适时组织对其进行监督检查，对零售药店的质量管理进行评价，依法严厉查处违法违规行为，定时将评价结果上网公示。市县市场监督管理局可结合《药品经营许可证》监督检查和药品经营质量管理规范跟踪检查、日常抽查、专项检查等，每季度至少对辖区内基本药物零售药店组织一次监督检查。第十八条 医疗机构必须按照规定加强基本药物管理，重点规范进货、验收、储存、调配等环节，保证基本药物质量。医疗机构购进基本药物，必须按照国家规定，建立进货检查验收制度，验明药品合格证明和其他包装标识，对不符合规定的药品，不得购进和使用。医疗机构应当按照法律法规的规定，建立真实、完整的基本药物购进记录。购进记录保存时间不得少于3年；药品有效期超过3年的，保存至药品有效期后1年。医疗机构必须制定和执行基本药物保管制度，采取必要的冷藏、防冻、防潮、防虫、防鼠等措施。第十九条　省药品监督管理局及市县市场监督管理局应当加强对医疗机构基本药物质量的监督检查，对质量检查、投诉、抽验等过程中发现的质量问题，要查明原因，采取有效处理措施。依法查处医疗机构在管理和销售中的违法行为，查处结果应当及时通报同级卫生行政管理部门。省药品监督管理局根据需要适时组织对医疗机构基本药物质量的监督检查。市县食品药品监督管理局每年至少对辖区内配备使用基本药物的社区卫生服务机构和基层医疗机构的药房管理组织一次监督检查。四、 抽 验第二十条　省药品监督管理局负责制定省内基本药物监督抽验年度计划，组织、协调全省基本药物的监督抽验工作。第二十一条　加强对省政府招标采购的国家基本药物中标品种的抽验，每年至少对省内基本药物生产企业生产的基本药物进行一次抽验。第二十二条　市县市场监督管理局应当结合本辖区实际，加强对辖区内基本药物经营企业和使用单位的监督抽验。第二十三条　对于抽验不合格的基本药物，省药品监督管理局应当及时发布药品质量公告，并通报省基本药物招标采购机构。五、药品不良反应监测及其他第二十四条 基本药物生产、配送企业以及医疗机构和零售药店应当建立健全药品不良反应报告、调查、分析、评价和处理制度，及时上报药品不良反应信息，对存在安全隐患的，应当依法采取控制及召回措施。第二十五条 各级药品不良反应监测机构应当进一步加强对基本药物药品不良反应的报告与监测工作，及时分析评价不良反应病例报告，完善并严格药品安全预警和应急处置机制。第二十六条 省药品监督管理局根据国家药品监督管理局的部署，逐步将基本药物品种纳入药品电子监管。第二十七条 本规定自发布之日起施行。《海南省食品药品监督管理局关于印发加强基本药物质量监督管理的规定的通知》（琼食药监安〔2009〕59号）同时废止。

2026年，巴彦淖尔市市场监管局积极探索医疗器械监管新模式，以“产品风险程度、企业信用状况、质量管理体系运行”三把核心标尺，对全市1221家医疗器械经营企业实行动态综合评定与分级分类，构建起层次清晰、靶向分明的四级监管体系，用精准监管守护群众用械安全。全市评定一级监管企业116家、二级监管企业989家、三级监管企业80家、四级监管企业36家，实现全市医疗器械经营企业“底数清、等级明、风险准”，为靶向守护群众用械安全筑牢基础。针对不同等级企业的风险特点，全市实施分类监管举措。对风险较高的三、四级监管企业，实行“全覆盖、严标准”监管，全年组织全项目检查不少于1次；对风险较低的一、二级监管企业，采取“随机抽、周期覆”模式，每年随机抽取本行政区域50%以上企业开展监督检查，确保两年内实现全域全覆盖。依托四级分类监管成果，巴彦淖尔市全面推行差异化监管，为巴彦淖尔市医疗器械产业高质量发展注入持续动力，实现安全保障与产业发展双向共赢，以高质量监管服务人民群众美好生活。

Delivery Method:VIA ELECTRONIC MAIL READ/DELIVERY RECEIPT REQUESTEDProduct:DrugsRecipient:Arthur FletcherGeneral CounselProRx LLC619 Jeffers CirExton, PA 19341-2540United StatesIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERWL # 723704April 7, 2026Dear Mr. Fletcher: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]1 on April 27, 2022, and most recently on February 20, 2026. From September 9, 2025, to September 19, 2025, an FDA investigator inspected your facility, ProRx LLC, located at 619 Jeffers Cir, Exton, PA 19341. During the inspection, the investigator 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. In addition, the investigator noted serious deficiencies in your practices for producing drug products intended or expected to be sterile, which put patients at risk.FDA issued a Form FDA 483 to your facility on September 19, 2025, and an amended Form FDA 483 on October 10, 2025. We reviewed your October 24, 2025, response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence on February 13, 2026. FDA also acknowledges that, on October 15, 2025, your firm initiated a voluntary recall of Lot PRORX08062025-3 of Tirzepatide Injection 27mg/3mL, 3mL in multidose vials and various lots of Semaglutide Injection multidose vials in multiple strengths, within expiry, due to a lack of sterility assurance. 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.In addition, for a drug product compounded using bulk drug substances to qualify for the exemptions under section 503B, the bulk drug substances that are used must appear on a list established by the Secretary identifying bulk drug substances for which there is a clinical need (“503B bulks list”), or the compounded drug must appear on the drug shortage list in effect under section 506E of the FDCA at the time of compounding, distribution, and dispensing (section 503B(a)(2)(A) of the FDCA [21 U.S.C. § 353b(a)(2)(A)]).In addition, for a compounded drug product to qualify for the exemptions under section 503B, the labeling of the drug must include certain information (section 503B(a)(10) of the FDCA [21 U.S.C. §353b(a)(10)]).Further, 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 investigator noted that drug products produced by your facility failed to meet the conditions of section 503B. For example, the investigator noted:1. Your facility compounded drug products using tirzepatide bulk drug substance. For example, on (b)(4), your facility compounded (b)(4) vials of Tirzepatide 72MG/4ML injectable drug product and on (b)(4), your facility compounded (b)(4) vials of Tirzepatide 45MG/2.5ML injectable drug product, using tirzepatide bulk drug substance on both dates. These drug products compounded using tirzepatide bulk drug substance are not eligible for the exemptions provided by section 503B because tirzepatide does not appear on the 503B bulks list and was not used to compound a drug that appears on FDA’s drug shortage list at the time of compounding, distribution, and dispensing (section 503B(a)(2)(A).32. Some of your facility’s drug products, such as Nicotinamide Adenine Dinucleotide Injection 1200mg, Glutathione Injection 2000mg, and Tirzepatide Injection 45mg/2.5mL, did not include the following statement on the label: the statement “Not for Resale” (section 503B(a)(10)(A)(iii)(IX)). Additionally, some of your facility’s drug products, such as Nicotinamide Adenine Dinucleotide Injection 1200mg, did not contain the following on the label: the established name of the drug (section 503B(a)(10)(A)(iii)(II)).3. 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).4 Specifically, your facility’s procedures for reporting adverse events are inadequate. For example, your documented procedures for reporting adverse events do not include an adequate definition of what constitutes a “serious” adverse event (21 CFR 310.305(b)) and do not require the firm to promptly investigate a serious, unexpected adverse event and submit a follow-up report within 15 calendar days of receipt of new information or as requested by FDA (21 CFR 310.305(c)(2)).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 FDCAAdulterated Drug ProductsThe FDA investigator noted that drug products intended or expected to be sterile were prepared, packed, or held under insanitary conditions, whereby they may have become contaminated with filth or rendered injurious to health, causing your drug products to be adulterated under section 501(a)(2)(A) of the FDCA. For example, the investigator noted:1. You did not perform adequate product evaluation and take appropriate corrective action after microbial contamination was recovered within the ISO 5 production area. Instead, your firm approved and distributed drug products that were produced with colony-forming unit (CFU) recoveries found on ISO 5 operator gloves and settle plates.2. An operator blocked first air by placing gloved hands and/or forearms directly over open tray of stoppers intended to be sterile during critical in-process operations within the ISO 5 production areas.3. You did not disinfect materials during transfer from the ISO 7 cleanroom into the ISO 5 laminar airflow workstation (LAFW). Specifically, an operator removed the outer packaging of stoppers in the ISO 7 area and the inner bag was then transferred from the ISO 7 area into the ISO 5 LAFW without surface disinfection. The inner bag of stoppers could be held for up to (b)(4) within the ISO 7 area before being transferred into the ISO 5 LAFW.4. An operator used non-sterilized scissor within the ISO 5 processing area. This scissor was used to cut open a bag of stoppers inside the ISO 5 LAFW during filling operation of drug product intended to be sterile. This scissor was routinely stored in the ISO 7 area and was only wiped with (b)(4) wipe prior to use.5. You had production areas or equipment that are difficult to clean or contain porous, particle-generating, or visibly dirty (e.g., rusty) equipment or surfaces (e.g., shelving, floors, walls, doors, ceilings). Specifically, the floor of the ISO Class 7 buffer room equipped with an ISO 5 LAFW and Biological Safety Cabinet (BSC) showed significant visible sporadic discoloration, the cause of which remains unknown.The FDA investigator also noted CGMP violations at your facility, that caused your drug products to be adulterated within the meaning of section 501(a)(2)(B) of the FDCA. The violations include, for example: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).2. Your firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas (21 CFR 211.42(c)(10)(iv)).3. Your firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes (21 CFR 211.113(b)).4. Your firm’s quality control unit failed to approve or reject all procedures or specifications impacting on the identity, strength, quality, and purity of the drug product (21 CFR 211.22(c)).5. Your firm failed to establish an adequate system for cleaning and disinfecting the room and equipment to produce aseptic conditions (21 CFR 211.42(c)(10)(v)).Outsourcing facilities must comply with CGMP requirements under section 501(a)(2)(B) of the FDCA. FDA’s regulations regarding CGMP requirements for the preparation of drug products have been established in 21 CFR parts 210 and 211. FDA intends to promulgate more specific CGMP regulations for outsourcing facilities. FDA has issued a revised draft guidance, Current Good Manufacturing Practice — Guidance for Human Drug Compounding Outsourcing Facilities under Section 503B of the FD&C Act. This draft guidance, when finalized, will describe FDA’s expectations regarding outsourcing facilities and the CGMP requirements in 21 CFR parts 210 and 211 until more specific CGMP regulations for outsourcing facilities are promulgated.Under section 301(a) of the FDCA [21 U.S.C. § 331(a)], the introduction or delivery for introduction into interstate commerce of any drug that is adulterated is a prohibited act. Further, it is a prohibited act under section 301(k) of the FDCA [21 U.S.C. § 331(k)] 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 adulterated.Unapproved New Drug ProductsYou do not have any FDA-approved applications on file for drug products that you compound.5 Under 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.6 The 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.D. Corrective ActionsWe have reviewed your facility’s October 24, 2025, response to the Form FDA 483 and acknowledge receipt of your subsequent correspondence on February 13, 2026. We also acknowledge on October 15, 2025, your firm initiated a voluntary recall of Lot PRORX08062025-3 of Tirzepatide Injection 27mg/3mL, 3mL in multidose vials and various lots of Semaglutide Injection multidose vials in multiple strengths, within expiry, due to a lack of sterility assurance.Regarding your October 24, 2025 response related to the insanitary conditions and CGMP violations, some of your corrective actions appear adequate; however, we cannot fully evaluate the adequacy of the following corrective actions described in your response because you did not include sufficient information or supporting documentation:1. Regarding your disinfectant efficacy studies, your response indicated initiating a comprehensive cleaning validation and disinfectant efficacy study on October 17, 2025, covering all disinfectants currently in use. You contracted (b)(4) to conduct efficacy testing against in-house isolates and common cleanroom contaminants, including molds and bacterial strains recovered during environmental monitoring (EM). While you agreed to share the protocol results with FDA once complete, the current status and expected completion timeline remain unclear, leaving questions about whether your existing cleaning disinfectants can adequately maintain your ISO 5 LAFWs, BSCs, and cleanroom environments.2. Regarding your floor discoloration of the ISO 7 cleanroom, your response indicated that a deviation investigation and corrective action and preventive action (CAPA) plan were initiated to address this issue. You determined the root cause to be the use of (b)(4), which exceeded the (b)(4) tolerance threshold of your existing (b)(4) flooring. Your corrective action involves installing replacement flooring capable of withstanding your cleaning protocol, followed by third-party cleanroom certification. You have suspended all aseptic compounding pending certification completion. However, your response lacks critical documentation, including evidence of when flooring construction occurred, documentation verifying the new flooring's appropriateness for pharmaceutical cleanroom use, and a timeline for completing construction and resuming aseptic production.Some of your corrective actions appear deficient:1. Regarding your failure to conduct adequate investigations, our comprehensive review of your firm’s multiple deviation reports and SOPs reveals significant deficiencies in documentation and execution procedures for out-of-specification (OOS) events and deviation investigations. The following examples illustrate some of these deficiencies:Your deviation reports (DEV-2025-05 and DEV-2025-06) provide only minimal information, such as the description of the deviation and the immediate action(s) taken. These reports lack critical details regarding the investigation into the root cause of the deviation.Your firm has not established clear criteria for determining when investigations should be initiated following the opening of a deviation. Specifically, SOP QA-190 Deviation Procedure section 2.e. states, “Upon accepting the Deviation Form QA determines if an investigation and/or CAPA is required, checks the appropriate box (Yes or No), assigns and records the investigation and CAPA number.” However, your revised SOPs (SOP QA-190, QA-080 Root Cause Investigation Procedure, and QA-180 Corrective and Preventative Action (CAPA) Procedure) do not provide any details on the criteria for determining when a deviation warrants a formal investigation and CAPA. This represents a critical gap in your quality management system.Your firm’s responses did not include any retroactive investigation or root cause analysis addressing the multiple microbial growth detected in personnel fingertip samples collected following production activities in the ISO 5 area. Nor did your firm perform any retroactive investigation or root cause analysis for the CFUs recovered from surface samples during (b)(4) EM of the ISO 5 areas.Your response did not address why investigations were not extended to other batches produced by operators when contamination was recovered on consecutive days during personnel monitoring of those same operators. Furthermore, a passing sterility test result does not indicate the absence of contamination within a batch, as microbial growth is not uniformly distributed throughout a batch.Your firm’s response regarding the recovery of 1 CFU of Trichoderma oriental from an air sample of the ISO 7 area during production of Tirzepatide 60mg/3mL on 01/16/25 was inadequate. While the 1 CFU recovered did not exceeded the ISO 7 acceptance limit, the nature of this microorganism necessitates further action. Since this organism is not part of the normal cleanroom flora and it was recovered during the capping process during the production of drug product intended to be sterile, your firm should have conducted an investigation and included this microbial recovery in the trending data.Furthermore, your SOPs (SOP QA-190, QA-080, and QA-180) are missing signatories (author, reviewer, QA approver) and an effective date, making it unclear whether these represent the final, official version of these SOPs. In fact, the majority of SOPs you provided in your response lack these critical signatories that are essential for Good Documentation Practices (GDP) to ensure accountability, authorization, and data integrity (ALCOA principles: attributable, legible, contemporaneously recorded, original or a true copy, and accurate).2. Regarding your firm’s deficiency in monitoring environmental conditions, your SOP CSP-080 Viable and Nonviable Air Sampling states viable air sampling “is conducted continuously during the compounding of CSPs in the ISO 5 environment by compounding personnel”. Our review of your SOPs and batch record reveals a fundamental misunderstanding of the distinction between active and passive viable air monitoring methods. Specifically, the viable monitoring documented in your batch record pertains to passive viable air monitoring (settle plate). While settle plates can provide valuable information about environmental monitoring conditions, they do not fulfill regulatory requirements. Active viable air monitoring is required under CGMP regulations. Furthermore, the viable air monitoring specification outlined in your SOP CSP-080 appears to address active viable air monitoring, yet no specifications are provided for the passive viable air monitoring.Furthermore, your firm’s SOP CSP-090 Surface Sampling Procedure states, "Surface sampling must be performed in all ISO classified areas on a (b)(4) basis, or more frequently on a risk-based approach if trending excursions are identified." This is inadequate, as surface monitoring should be conducted at least (b)(4) during operations within the ISO 5 area.3. Regarding your March 19, 2025, Dynamic Smoke Study, your response claimed the study demonstrated that first air to the stoppers was maintained and there was no contamination risk from your operator forearms during the stoppering process in your ISO 5 area. However, our review of your dynamic smoke study reveals several critical deficiencies that contradict these claims. The video footage shows operators extending their forearms and gloved hands directly over both the sterile stopper tray and open vial tray during stoppering operations in the ISO 5 hood, contradicting your assertion of no obstruction. Moreover, the stopper tray was empty during the smoke study, operators were simulating stopper pickup with tweezers and transfer over open vials rather than performing actual operations.Additionally, the smoke study reveals significant airflow concerns in both the ISO 5 LAFW and ISO 7 cleanroom. The air movement exhibits an (b)(4) trajectory toward the ceiling rather than the top-down movement and dilution of HEPA filtered air in the ISO 7 cleanroom. This (b)(4) pattern in the ISO 5 LAFW suggests that vials and stoppers may not be receiving adequate first air protection. Furthermore, the vial tray positioning creates a raised lip around the tray perimeter that may further impede proper airflow and compromise sterile protection of open vials. Visible turbulence is evident over the vial tray, further indicating compromised airflow.4. Regarding your media fills, your firm’s response indicates that SOP PT-020 Personnel Aseptic Qualification has been revised to require each operator to complete (b)(4) successful media fill runs that simulate actual production conditions. The revised SOP incorporates "best- and worst-case scenarios" with varying unit quantities (ranging from minimum of (b)(4) to a maximum of (b)(4)) and different fill volumes (1.2mL, 10.4mL and 30.4mL). However, your firm did not provide the media fill production batch record that would demonstrate how these requirements are implemented in your actual media fill procedures. Furthermore, while your response states all operators will be retrained and requalified on the revised SOP, no timeline was provided for completing this retraining and requalification.5. Regarding your lack of change control, your firm’s response maintains that construction at your facility is occurring in an adjacent suite and poses no cross-contamination risk to the aseptic cleanroom. However, you did not provide any change control documentation, risk assessment, or other supporting evidence demonstrating how construction of a new facility within the same building does not pose a risk of cross-contamination and loss of environmental control. Such risks include particulate and microbial intrusion, personnel and material movement, and disruption of facility integrity.Additionally, your firm’s response states you are implementing a robust change control system. However, review of your revised change control documents (QA-241 Change Control Form, QA-240 Change Control Management Procedure, and related training logs) reveals inadequate instructions and insufficient detail for personnel to properly assess and execute the change control process. Key deficiencies include Attachment #1: Change Impact and Risk Assessment Checklist, which appears to be a required component of the QA-241 Change Control Form but is not referenced in SOP QA-240. Neither document provides criteria for evaluating the impact and risk associated with each item within the checklist. The checklist uses a simple Yes/No format without requiring justification or rationale for conclusions and the impact/risk assessment checklist appears to depend solely on the requester rather than involving a multidisciplinary team or subject matter experts. The procedure fails to specify QA's approval or rejection criteria and does not clarify whether decisions rely exclusively on checklist responses. There are no provisions for assessing change effectiveness or consequences post-implementation.6. Regarding your visual inspection (VI) program, your firm’s response indicates that you are “engaging all operating personnel in a robust visual inspection competency and training program.” However, your visual inspection documents (QA-220 Acceptance Sampling Procedure, CSP-140 Visual Inspection Procedure, and PT-100 Visual Inspection Qualifications Procedure) provided with your response contain significant deficiencies. For example, your visual inspection qualification exam uses only (b)(4) with a (b)(4) time limit, despite batch sizes that range from (b)(4). The exam also employs a scoring system that lacks clear scientific justification for the assigned point values.Furthermore, your revised procedures eliminated the previous requirement for (b)(4) as part of your personnel qualification of operator conducting visual inspection. This requirement should be maintained as essential criteria for inspector qualification to ensure inspectors possess adequate visual acuity to identify defects. Additionally, your firm's SOP CSP-140 delegates defect categorization entirely to quality control (QC) personnel after inspection by your operations personnel. Your visual inspection procedures do not address the disposition of defective units identified by operators but not confirmed by QC personnel. It remains unclear whether such units would be included in batch release or rejected.Your firm’s defect classification system for minor, major and critical defects remain inadequate. Your firm did not provide scientific justification for classifying all particulates as major defects. A risk-based approach should evaluate multiple factors—including particle size, route of administration, and whether particulates are extrinsic or intrinsic—to determine the appropriate defect classification. Additionally, SOP CSP-140 classifies loose and missing crimps as minor defects despite their potential to compromise container closure integrity, permit microbial ingress, and threaten sterility assurance of your drug product intended to be sterile.We acknowledge that SOP QA-220 Acceptance Sampling Procedure establishes a framework for AQL statistical sampling and defines limits for minor, major, and critical defect classifications. However, your visual inspection competency and training program exhibits significant deficiencies, as discussed above. Given these deficiencies, it does not appear your firm can appropriately classify the different type and category of defects to adequately execute statistical sampling and classification.Your firm’s response also does not address batch yield specification as part of the VI program. Lastly, your response does not discuss the implementation of defect library or the training of VI inspectors and QC personnel using this library.In addition to the issues discussed above, you should note that CGMP requires the implementation of quality oversight and controls over the manufacture of drugs, including the safety of raw materials, materials used in drug manufacturing, and finished drug products. See section 501 of the FDCA. If you choose to contract with a laboratory to perform some functions required by CGMP, it is essential that you select a qualified contractor and that you maintain sufficient oversight of the contractor’s operations to ensure that it is fully CGMP compliant. Regardless of whether you rely on a contract facility, you are responsible for assuring that drugs you produce are neither adulterated nor misbranded. [See 21 CFR 210.1(b), 21 CFR 200.10(b).]Furthermore, regarding issues related to the conditions of section 503B of the FDCA, your corrective actions appear deficient: Although you submitted revised labels that adequately corrected the labeling deficiencies noted during the inspection, your revised label for Nicotinamide Adenine Dinucleotide no longer includes a list of active and inactive ingredients, identified by established name and the quantity or proportion of each ingredient, as required by section 503B(a)(10)(iii)(X).You did not address certain issues related to the conditions of section 503B of the FDCA, for example:1. You did not address the issue of your firm compounding drugs using tirzepatide bulk drug substance.2. You did not submit updated documented procedures for reporting adverse events.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.FDA strongly recommends that your management undertake a comprehensive assessment of operations, including facility design, procedures, personnel, processes, maintenance, materials, and systems. In particular, this review should assess your aseptic processing operations. A third party consultant with relevant sterile drug manufacturing expertise should assist you in conducting this comprehensive evaluation.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 (# 723704) 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/Matthew J. LashActing DirectorOffice of Compounding Quality and ComplianceOffice of ComplianceCenter for Drug Evaluation and Researchcc: Gregory G. Gaiser, Senior Vice President____________________1 See Pub. L. No. 113-54, § 102(a), 127 Stat. 587, 587-588 (2013).2 We 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.3 These substances are also not within the scope of the policy applicable to certain bulk drug substances described in the final guidance titled, Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act (Revision 1). This guidance describes FDA’s interim regulatory policy for entities registered as outsourcing facilities under section 503B of the FDCA while the 503B bulks list is being developed. Specifically, the guidance sets out conditions under which FDA generally does not intend to take action against an outsourcing facility for compounding a drug product using a bulk drug substance that is not included on the 503B bulks list and that is not used to compound a drug that appears on the drug shortage list in effect under section 506E at the time of compounding, distribution, and dispensing. These conditions include that the drug product appears on “503BCategory 1 – Bulk Drug Substances Under Evaluation”, which includes substances that may be eligible for inclusion on the 503B bulks list, was nominated with adequate support for FDA to evaluate it, and has not been identified by FDA as a substance that appears to present significant safety risks pending further evaluation. For additional information, see the guidance athttp://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM469122.pdf4 For 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.5 The 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.6 Your 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).