2025年，自治区中医药局党组坚持以习近平新时代中国特色社会主义思想为指导，深入学习贯彻党的二十大和二十届历次全会精神，学深悟透习近平法治思想，全面贯彻习近平总书记关于健康中国建设和中医药工作的重要论述，推进法治政府建设各项工作，统筹推动全区中医药（壮瑶医药）传承创新发展取得新成效新进展。一、坚持政治引领，落实法治建设要求（一）突出学习习近平法治思想。突出政治建设，局党组书记严格履行法治建设第一责任人职责，通过局党组理论学习中心组学习、集体学习、专题学习等形式，深入学习贯彻党的二十大和二十届历次全会精神，学深悟透习近平法治思想，坚持用习近平法治思想武装头脑、指导实践、推动工作。（二）突出学法用法。深入学习宣传宪法法律、党内法规及卫生健康、中医药相关法律法规，推动依法行政。（三）深入开展学习教育。开展深入贯彻中央八项规定精神学习教育“学查改”及“回头看”各项工作，压实全面从严治党主体责任，开展党风廉政建设集体谈话。（四）严格执行重大决策程序制度。执行“三重一大”决策机制，按照《局党组议事决策规则》《局党组“三重一大”事项集体决策制度》，严格依法依规决策。落实法律顾问制度，认真履行行政规范性文件合法性审核、政策措施公平竞争审查等要求。二、坚持法治思维，强化中医药法治监督工作（一）统筹推进监督执法工作。深入推进国家中医药监督执法实训基地建设，建设自治区中医药监督执法实训基地（广西国际壮医医院）并揭牌启用。举办两期中医药监督执法人员培训班，开展中医药监督执法典型案例评查、办案能手评选，推进严格规范公正文明执法。强化跨部门联动，联合开展2025年全区卫生健康随机监督抽查、卫生健康领域规范涉企行政执法专项行动、广西医保基金管理突出问题专项整治、做好持续严厉打击医疗领域侵害人民群众健康权益违法违规行为等工作，保障人民群众健康权益。（二）有序推进中医药标准化工作。联合多部门举办中医药标准化国际会议（中国南宁）暨世界中医药学会联合会标准化建设委员会2025年学术年会。推动4项ISO国际标准研制，推动获批发布2项中医药地方标准、发布跨国团体标准1项。举办2025年中医药标准化综合知识培训班、壮瑶医药“名技法”师资培训班。（三）做好普法工作。推动“八五”普法工作顺利收官，完成“八五”普法规划实施自评工作。落实“谁执法谁普法”普法责任制，结合“宪法宣传周”、“民法典宣传月”、中医药法实施周年、中医药条例实施周年等重要时间节点和“名中医八桂行”、中医药文化进基层及中医药健康文化素养知识宣教、广西中医药文化服务月暨文化市集活动周、中医药文化夜市等重大活动开展普法宣传，营造良好法治氛围。组织局机关及局直属单位完成2025年度国家工作人员学法用法考试。推行顾问律师定期到局里坐班，现场解答法律方面的问题并提供相关法律咨询服务。三、坚持实干为要，依法推动中医药高质量发展（一）服务能力提质扩面。玉林市入选国家中医药传承创新发展示范项目，广西中医药大学第一附属医院等4家医院入选智慧中医医院试点项目，柳州市中医医院获批国家级优势专科增补培育单位。县级中医医院“两专科一中心”建设覆盖率达95％，社区卫生服务中心和乡镇卫生院中医馆实现全覆盖。深入推进中西医协同，持续加强中西医协同“旗舰”医院和科室建设，“西学中”培训基地达到19个。强化中医专科护士培训基地建设，推动多家三级公立中医医院完善中医护理门诊建设。（二）人才科技培优攀高。2人入选2024年岐黄学者培养项目，广西中医药大学“西南少数民族特色名贵和濒危药用资源综合利用与开发”项目入选国家重点研发计划“中医药现代化”重点专项，我区国家级中医药重点研发计划项目和领军人才双双实现“零突破”。新增建设全国老药工传承工作室4个、妇幼领域全国名老中医药专家传承工作室共21个，组织40个名中医团队开展“名中医八桂行”活动。（三）产业发展强链扩能。在全国率先颁发“药膳制作师”技能等级证书，推进药膳餐厅、药膳大赛规范和十大药膳等标准制定工作，推动药膳成果转化和标准化建设。南宁国家植物园创建工作加速推进。打造连通中药材种植户和生产流通企业的中药材质量追溯平台。（四）文化惠民强基焕彩。开展中医药文化进基层、进校园、进企业以及“中医药文化服务月”“百市千县”文化惠民、国门边境行等系列活动400多场，服务群众约34.3万人次。举办中医药文化创意大赛，召开广西“时令、时事与健康”新闻发布会，制作“二十四节气命中医话养生”等科普内容。举办2025面向东盟大健康旅游国际论坛和面向东盟的系列研修班、培训班，组团出访阿联酋、马来西亚，深化与大湾区对接，推动中医药高质量融入共建“一带一路”。（五）做好信访、行政复议和行政应诉等工作。依法稳妥办理行政复议、行政诉讼、信访、12345投诉等工作，及时有效化解社会矛盾纠纷。按时高质量办结人大代表建议和政协提案52件。四、存在不足和困难虽然法治政府建设取得了一些成绩，但也存在一些不足，主要是：监督执法人员不足，监督执法能力有待提升；普法精准性有待进一步提升，与受众的实际需求和关注点结合不够紧密；中医药标准体系有待完善等。五、下一步工作打算2026年，我局将坚持以习近平新时代中国特色社会主义思想为指导，深入践行习近平法治思想，牢固树立和践行正确政绩观，强化中医药监督执法实训基地、监督执法队伍建设，深化法治宣传教育工作，加快构建中医药标准体系等，以更大力度、更实举措统筹推进法治政府建设，提升运用法治思维和法治规则想问题、做决策、办事情的能力，为全区中医药（壮瑶医药）传承创新发展提供良好法治氛围。

　　按照《中华人民共和国药品管理法》《中华人民共和国行政许可法》和《药品经营和使用质量监督管理办法》等相关规定，根据商丘嘉信医药商贸有限公司申请，现注销商丘嘉信医药商贸有限公司的《药品经营许可证》（证书编号：豫AA370000063）。　　特此公告。　　附件：商丘嘉信医药商贸有限公司《药品经营许可证》有关信息表　　2026年3月25日附 件商丘嘉信医药商贸有限公司《药品经营许可证》（批发）有关信息表企业名称企业法人（负责人）主要负责人质量负责人经营方式经营范围经营地址仓库地址证书编号商丘嘉信医药商贸有限公司马明林马明林孙玉国批发中药饮片、中成药（含冷藏药品）、化学药（含冷藏药品）、生物制品（含冷藏药品）、蛋白同化制剂、肽类激素（含冷藏药品）商丘市睢阳区归德南路与工业大道交叉口商丘市睢阳区归德南路与工业大道交叉口《药品经营许可证》（证号：豫AA370000063）

  2026年3月19日，我局对锦州九洋药业有限责任公司违反《药品生产质量管理规范》（2010版）开展药品生产活动的整改情况进行了现场检查。根据现场检查结果，经综合评定，决定同意锦州九洋药业有限责任公司恢复对乙酰氨基酚片的生产。   特此通告。    辽宁省药品监督管理局2026年3月24日

近日，省医疗器械审评中心在杭州组织召开《心磁信号采集设备注册审查指导原则》（以下简称《指导原则》）定稿会，标志着该项指导原则的制定工作圆满完成。 心磁信号采集设备作为极弱磁技术在临床诊断领域的最新应用，是一种非接触、无创、无辐射的新型高端医疗装备，通过采集人体心脏磁信号并进行成像分析，是目前高端医疗器械领域的前沿发展方向之一。作为国家重点培育的创新产业增长点，极弱磁测量技术已成为浙江省重点布局的未来产业方向。目前，浙江已形成了以杭州高新区（滨江）为核心的“零磁科学谷”和以湖州德清为重点的“地磁产业谷”双轮驱动格局。 在《指导原则》制定过程中，省医疗器械审评中心课题组始终坚持科学引领、问题导向。前期，课题组深入开展了国内外相关标准、技术文献及产品临床研究进展的调研工作，并专程赴北京、上海、山东等地，对多家具有代表性的研发生产企业以及医疗机构进行了调研，面对面听取企业在产品设计、性能验证及注册申报过程中的难点与诉求，广泛吸纳各方智慧。 本次定稿会上，课题组详细汇报了项目的研究历程、关键技术点的考量、初稿及中期研讨后的修改情况，以及面向全社会公开征求意见的汇总分析与处理结果。与会专家和代表围绕《指导原则》送审稿进行了严谨细致的审议，重点针对产品名称、性能指标、适用范围等核心内容进行了深入研讨，并最终达成共识。 医疗器械注册审查指导原则是保障上市医疗器械安全有效的重要技术支撑，也是连接科学监管与产业创新的桥梁。此次《指导原则》制定工作的圆满完成，不仅为国家层面统一该类产品的审评尺度贡献了“浙江智慧”，也为我省抢占高端医疗器械新赛道、推动相关产业集群高质量发展提供了坚实的技术支持。

各省、自治区、直辖市和新疆生产建设兵团药品监督管理局：　　为贯彻落实《国务院办公厅关于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的意见》（国办发〔2024〕53号）、《药品经营和使用质量监督管理办法》，推动药品批发企业和药品第三方物流企业有序高效开展药品现代物流规范化建设，进一步规范药品批发企业准入，持续提升药品流通环节质量管理水平，国家药监局组织制定《药品现代物流规范化建设指导意见》，现予以印发。请对照完善本行政区域药品批发企业和药品第三方物流企业标准，在经营许可准入、经营许可证换发、日常监管检查等工作中结合实际贯彻落实。附件：药品现代物流规范化建设指导意见　　　　国家药监局2026年3月20日

　　按照《中华人民共和国药品管理法》《中华人民共和国行政许可法》和《药品经营和使用质量监督管理办法》等相关规定，根据重庆医药集团郑州有限公司申请，现注销重庆医药集团郑州有限公司的《药品经营许可证》（证书编号：豫AA371000616）。　　特此公告。　　附件：重庆医药集团郑州有限公司《药品经营许可证》有关信息表　　2026年3月25日附 件重庆医药集团郑州有限公司《药品经营许可证》（批发）有关信息表企业名称企业法人（负责人）主要负责人质量负责人经营方式经营范围经营地址仓库地址证书编号重庆医药集团郑州有限公司鹿慎言鹿慎言刘章华批发中药饮片、中成药(含冷藏药品)、化学药(含冷藏药品)、生物制品(含冷藏药品)、第二类精神药品（制剂）、蛋白同化制剂、肽类激素(含冷藏药品)郑州市管城区紫荆山路56号3层0308号郑州经济技术开发区南三环东路191号三号厂房1-2层《药品经营许可证》（证号：豫AA371000616）

　　深圳普博腾迈医疗科技有限公司等7家注册人向广东省药品监督管理局主动提出注销产品注册证的申请。根据《医疗器械监督管理条例》的规定，现对上述7家注册人持有的26张《医疗器械注册证》依法予以注销（注销清单见附件）。　　特此通告。　　附件：医疗器械注册证注销清单广东省药品监督管理局2026年3月24日　　附件医疗器械注册证注销清单序号注册人名称注册证编号产品名称1深圳普博腾迈医疗科技有限公司粤械注准20212141531输液泵2广东精观生物医药科技有限公司粤械注准20232060104荧光摄像系统3广东龙帆生物科技有限公司粤械注准20212400633C—反应蛋白检测试剂盒（荧光免疫层析法）4广东龙帆生物科技有限公司粤械注准20212400634降钙素原检测试剂盒（荧光免疫层析法）5广东龙帆生物科技有限公司粤械注准20212400635血清淀粉样蛋白A检测试剂盒（荧光免疫层析法）6深圳驼人生物医疗电子股份有限公司粤械注准20192060119彩色超声诊断系统7深圳驼人生物医疗电子股份有限公司粤械注准20182061019彩色超声诊断系统8深圳驼人生物医疗电子股份有限公司粤械注准20222060045彩色超声诊断系统9深威（深圳）医疗科技有限公司粤械注准20222080618压缩式雾化器10深威（深圳）医疗科技有限公司粤械注准20222140514电动洗鼻器11深圳驼人生物医疗电子股份有限公司粤械注准20172062022彩色超声诊断系统12深威（深圳）医疗科技有限公司粤械注准20222090775医用物理降温仪13深威（深圳）医疗科技有限公司粤械注准20222140513电动喷雾洗鼻器14深圳传世生物医疗有限公司粤械注准20202221185全自动凝血分析仪15深圳传世生物医疗有限公司粤械注准20202401885凝血酶原时间（PT）测定试剂盒（凝固法）16肇庆巧巧日用化工有限公司粤械注准20202142079一次性使用医用口罩17深圳传世生物医疗有限公司粤械注准20202401886凝血酶时间（TT）测定试剂盒（凝固法）18深圳传世生物医疗有限公司粤械注准20202401887纤维蛋白原（FIB）测定试剂盒（凝固法）19深圳传世生物医疗有限公司粤械注准20212220691全自动凝血分析仪20深圳传世生物医疗有限公司粤械注准20202402189D—二聚体（D—Dimer）测定试剂盒（免疫比浊法）21深圳传世生物医疗有限公司粤械注准20212401118纤维蛋白（原）降解产物（FDP）测定试剂盒（免疫比浊法）22深圳传世生物医疗有限公司粤械注准20222400038抗凝血酶III测定试剂盒（发色底物法）23深圳传世生物医疗有限公司粤械注准20232401150凝血质控品24深圳传世生物医疗有限公司粤械注准20232401151D—二聚体（D—Dimer）质控品25深圳传世生物医疗有限公司粤械注准20232401153纤维蛋白（原）降解产物（FDP）质控品26深圳传世生物医疗有限公司粤械注准20202401888活化部分凝血活酶时间（APTT）测定试剂盒（凝固法）

为切实规范药品经营行为，守护辖区群众用药安全，近日，太原市杏花岭区市场监管局聚焦执业药师在岗、“回流药”排查、明码标价等关键环节，开展药店监督检查，用“铁腕”监管筑牢药品安全防护网。监督检查重点核查药店是否在营业期间按规定配备执业药师，药师是否在岗履职、是否规范开展处方审核与用药咨询服务，对药师注册信息、在岗公示情况等进行细致检查；深入排查药店药品进货渠道，重点核查药品采购记录、验收台账、储存条件等，严厉打击从非法渠道购进药品、销售过期药品、篡改药品有效期等违法行为。同时，向药店经营者普及“回流药”危害及法律后果，督促药店严格执行药品追溯制度，从源头杜绝“问题药”流入消费者手中，切实斩断非法药品流通链条。检查中，执法人员对药店药品标价签是否规范、价格信息是否清晰完整、是否存在“阴阳价”“哄抬药价”等行为进行全面检查。要求药店对所有药品实行“一药一价签”，清晰标注药品名称、规格、单价等信息，确保消费者购药时“看得懂、算得清”。药品安全无小事，监管责任大于天。杏花岭区局将持续加大对辖区药店监督检查力度，通过“日常检查+突击抽查+回头看”相结合的方式，常态化筑牢药品安全防线，让“放心药”走进千家万户。

Delivery Method:Via Electronic Mail - Return Receipt RequestedReference #:320-26-54Product:DrugsRecipient:Mr. Jingcheng GaoGeneral ManagerYangzhou H&R Plastic Daily Chemical Co., Ltd.188 Xingyuan RoadHangjiGuangling QuYangzhou ShiJiangsu Sheng,225111ChinaIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter320-26-54March 18, 2026Dear Mr. Gao:The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Yangzhou H&R Plastic Daily Chemical Co., Ltd., FEI 3014543859, at 188 Xingyuan Road, Hangji, Guangling, Yangzhou, Jiangsu, from October 21 to 24, 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 have not received a response from your firm stating your actions to address the deficiencies identified during the inspection and cited on our Form FDA 483. We note that you continue to ship drug products to the United States.During our inspection, our investigator observed specific violations including, but not limited to, the following.1. Your firm failed to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release (21 CFR 211.165(a)).Your firm contract manufactures an over-the-counter(b)(4)drug product. You failed to adequately test batches of your finished drug product for the identity and strength of your active ingredient (e.g.(b)(4)) before release and distribution. Your specification procedures only discuss appearance, color, and weight checks prior to batch release.Full release testing, which includes strength and identity testing of the active ingredient, must be performed before drug product batch release and distribution. Without adequate testing, you do not have adequate scientific evidence to assure that drug product batches conform to appropriate specifications before release.In response to this letter, provide:A comprehensive, independent assessment of your laboratory practices, procedures, methods, equipment, documentation, and analyst competencies. Based on this review, provide a detailed plan to remediate and evaluate the effectiveness of your laboratory system.A list of chemical and microbial specifications, including test methods, used to analyze each lot of your drug products before a lot disposition decision.o An action plan and timelines for conducting full chemical and microbiological testing of retain samples to determine the quality of all batches of drug product distributed to the United States that are within expiry as of the date of this letter.o A summary of all results obtained from testing retain samples from each batch. If such testing reveals substandard quality drug products, take rapid corrective actions, such as notifying customers and product recalls.2. Your firm failed to conduct at least one test to verify the identity of each component of a drug product. 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 conduct adequate identity testing on incoming components, including active pharmaceutical ingredients, used in the manufacturing of your drug products. Additionally, you relied on your suppliers’ certificates of analyses (COA) without establishing the reliability of each of your component suppliers’ analyses at appropriate intervals.Without adequate testing and confirmation of reliability of supplier test results, you lack scientific evidence that the components conform to appropriate specifications prior to use in the drugs products you manufacture.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.Based on a thorough review, provide a summary of your systems corrective actions and preventive actions to remediate the vendor qualification program and prevent use of unsuitable components, containers and closures.The chemical and microbiological quality control specifications you use to test and release each incoming lot of component 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 standard operating procedure that describes this COA validation program.A summary of your program for qualifying and overseeing contract facilities that test the drug products you manufacture.3. Your firm failed to establish adequate written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(a)).Your firm failed to adequately qualify the equipment and validate the processes used to manufacture your(b)(4)drug product. You have not performed process performance qualification (PPQ) studies, nor do you have a meaningful ongoing program for monitoring process control, to ensure stable manufacturing operations and consistent drug quality.Process validation evaluates the soundness of design and state of control of a process throughout its lifecycle. Each significant stage of a manufacturing process must be designed appropriately to ensure the quality of raw material inputs, in-process materials, and finished drugs. Process qualification studies determine whether an initial state of control has been established. Successful process qualification studies are necessary before commercial distribution. Thereafter, ongoing vigilant oversight of process performance and product quality are necessary to ensure that you maintain a stable manufacturing operation throughout the product lifecycle.See FDA’s guidance document for general principles and approaches that FDA considers appropriate elements of process validation, at https://www.fda.gov/media/71021/download.In response to this letter, provide:A detailed summary of your validation program for ensuring a state of control throughout the product lifecycle, along with associated procedures. Describe your program forprocess performance qualification, and ongoing monitoring of both intra-batch and inter-batch variation to ensure a continuing state of control.A timeline for performing appropriate PPQ 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.Process performance protocol(s), and written procedures for qualification of equipment and facilities.A detailed program for designing, validating, maintaining, controlling and monitoring each of your manufacturing processes that includes vigilant monitoring of intra-batch and inter-batch variation to ensure an ongoing state of control. Also, include your program for qualification of your equipment and facility.4. Your firm’s quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP, and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22).Your firm failed to establish an adequate quality unit (QU) with the responsibilities and authority to oversee the manufacture of drug products. For example, you failed to ensure:Adherence to an adequate stability program (21 CFR 211.166(a)).Consistent and complete batch records (21 CFR 211.188).Appropriate examination of labeling and packaging materials for correctness, including but not limited to sufficiently accounting for all ingredients used in manufacturing, prior to packaging operations (21 CFR 211.130(d)).There was a fundamental failure of production management to effectively oversee the procedures, practices, and suitability of the manufacturing operations. In addition, even when a QU consists of one or only a few, those persons are still accountable for overseeing ongoing effectiveness of all systems and procedures, and review of the results of manufacture to ensure state of control and adherence to all quality standards.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.Quality SystemsYour firm’s quality systems are inadequate. See FDA’s guidance documentICH Q10 Pharmaceutical Quality System, as well asQuality Systems Approach to Pharmaceutical CGMP Regulations, for 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/71553/download and https://www.fda.gov/media/71023/download, respectively.CGMP Consultant RecommendedBased upon the nature of the violations we identified at your firm, you should engage a consultant qualified as set forth in 21 CFR 211.34 to evaluate your operations and to assist your firm in meeting CGMP requirements if your firm intends to resume manufacturing drugs for the U.S. market. 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 corrective actions and preventive actions 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.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.FDA placed all drugs and drug products offered for import into the United States from your firm on Import Alert 66-40 on February 13, 2026.Correct any violations promptly. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to any violations.Failure to address any violations may also result in the FDA continuing to refuse admission of articles manufactured at 188 Xingyuan Road, Hangji, Guangling, Yangzhou, Jiangsu, 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 3014543859 and ATTN: Philip Kreiter.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and Research

　　近日，省药品监督管理局正式发布《广东省化妆品企业生产质量管理体系提升三年行动方案（2026—2028年）》，旨在全面推动全省化妆品产业高质量发展，助力广东从“规模领先”向“质量引领”“创新驱动”跨越，打造化妆品制妆强省和品质标杆。　　到2028年底，计划力争实现四大核心目标：企业主体责任意识全面增强，关键岗位人员履职能力大幅提升；企业质量体系运行水平整体提升，风险防控能力显著增强；产业质量基础更加稳固，标杆企业带动产业链协同进步；监管服务能力持续优化，多方参与的社会共治格局基本形成，切实守护群众用妆安全与权益。　　为落实目标，计划部署三大方面的16项重点任务与落实举措：精准施策助力企业质量体系提档升级，梳理行业共性问题，完善“三位一体”质量提升机制，建立三级责任体系与全员培训机制，提升关键岗位人员履职能力，强化质量安全风险防控能力；优化环境促进化妆品产业高质量发展，优化生产质量管理制度，提升质量体系监管效能，培育美妆头部企业与国际知名品牌，全力支持广州“国际美湾”建设，扩大“广州国际美妆周”影响力，依托大湾区科研资源推动技术创新，推广标杆企业经验，基本形成社会共治格局；赋能发展推动监管部门服务效能提升，推行分级分类监管，完善检查标准，全力构建化妆品全链条智慧监管体系，加强监管队伍专业化建设，变事后查处为事前服务。　　该计划的实施，将全面提升广东化妆品产业整体质量水平，破解行业发展痛点，为全国化妆品产业高质量发展与监管创新提供广东实践，助力粤妆品牌走向国际市场。（省局化妆品监管处供稿）