企业名称格林血液制品（辽宁）有限公司企业类型医疗器械生产企业检查时间2026年1月8日-2026年1月8日,2026年1月12日-2026年1月12日所在地市辽阳市检查依据《医疗器械监督管理条例》《医疗器械生产监督管理办法》《医疗器械生产质量管理规范》等法规规章和规范性文件 检查事项医疗器械生产检查检查方式有因检查;常规检查检查内容1.第一类医疗器械产品备案变更情况；2.贯彻落实《医疗器械监督管理条例》《医疗器械生产监督管理办法》及《医疗器械生产质量管理规范》情况。存在问题在文件管理方面存在个别记录填写不规范问题；在不良事件监测、分析和改进方面存在未建立产品信息告知程序问题。处理措施限期整改整改情况已按要求完成整改

　　广东省药品检验所积极响应中国食品药品检定研究院提出的“1+N+N”监管科学研究机制，勇担首个“N”角色，争当机制建设排头兵，相关工作取得积极成效。在2025年度“1+N+N”机制建设示范项目评选中，省药检所承担的“化妆品中高风险物质的筛查确证技术和标准参考数据库研究”示范任务荣获优秀项目。 面对广东省化妆品产业规模全国领先、安全监管挑战日益复杂的形势，省药检所聚焦风险防控关键环节，创新构建了集“筛查-预测-确证-评价”于一体的化妆品风险智慧监管“一站式”平台。该平台深度融合人工智能、高分辨质谱、计算毒理学等前沿技术，实现了从风险智能识别、快速预测到精准确证与科学评价的全流程闭环管理。平台应用成效显著，不仅大幅提升了高风险物质的检出效率与准确性，创新揭示了“地塞米松磷酸酯”等新型风险物质的毒性机制，还为监管部门提供了有力的技术支撑和决策依据，有效助力产业规范与高质量发展。 通过深度参与机制建设与实践创新，省药检所不断强化自身技术能力与科技创新水平，2025年获科技和上级主管部门项目立项96项，获得经费资助639.38万元。形成了一批新标准、新方法、新工具，获得专利授权7项，软著授权2项，以第一/通讯作者发表研究论文73篇（SCI 15篇），展现了强大的创新活力与学术影响力，为全国药检系统提升监管科学研究水平贡献了“广东智慧”与“广东方案”。

行政相对人名称安徽特仑沙克生物科技研究有限公司行政相对人类别法人及非法人组织统一社会信用代码91340102MA2RRWYE0Y法定代表人郑前进行政处罚决定书文号皖药监妆处罚﹝2026﹞1-5号处罚类别罚款;没收违法所得处罚决定日期2026-01-30处罚内容1.没收违法所得人民币陆仟零贰拾元； 2.罚款: 人民币壹万元整。 罚没款合计壹万陆仟零贰拾元。罚款金额（万元）1.000000没收违法所得、没收非法财物的金额（万元）0.602000暂扣或吊销证照名称及编号违法行为类型《化妆品监督管理条例》第二十九条违法事实国家局有因检查中发现关于当事人未按照备案资料载明的技术要求组织生产的关键项目缺陷属实，当事人生产质量管理体系存在严重缺陷。当事人2025年8月-9月期间，投料生产的8批特仑沙克嫩肤香氛沐浴露和1批AZQJ多效修护护发膜实际生产工艺与验证工艺一致，但与备案工艺不一致，上述批次产品共计生产301桶（25L/桶）、1320瓶（750ml/瓶）、9985瓶（50ml/瓶），除规格为25L/桶的301桶产品以20元/桶的价格销售外，其它规格产品均为赠送，涉案产品货值金额6020元，违法所得6020元。处罚依据《化妆品监督管理条例》第六十条第一款第（三）项处罚机关安徽省药品监督管理局处罚机关统一社会信用代码11340000MB19570665数据来源单位安徽省药品监督管理局数据来源单位统一社会信用代码11340000MB19570665状态

一、各企业须按质价相符原则，依法依规审慎申报，如实填报全国省级中标价或挂网价；同时承诺提供的价格真实有效，若有虚报、瞒报、漏报者，将取消相关产品参与四川药械集采资格，并承担相应的法律责任。二、平台将对药械产品价格实施动态监测，综合运用大数据对产品价格实施红、黄、绿三区间监管；医疗机构若频繁采购红、黄区间价格药械产品，相关采购行为问题线索将被移交至行政主管部门及同级纪委监委。三、医药企业若存在违规挂网、违规营销及其他违纪违规行为的，企业及相关产品将被纳入重点监测、信用评价范畴，相关违规产品将被动态调出，同时将取消相关违规产品参与四川药械集采资格。

春节将至，为切实保障节日期间辖区群众用药安全，筑牢药品安全防线，省药监局宜昌分局紧扣节日期间药品消费特点与监管重点，认真谋划、精心组织，统筹开展药品安全专项检查行动。本次专项检查为期一个月，共出动执法人员 44人次，检查企业22家次，发现案件线索3条，发现风险隐患25项，责令整改10家。一、统筹安排检查对象，实现靶向发力立足节日监管需求，结合省局工作要求，分层分类确定四大检查重点，统筹确定检查对象，按监管对象总数15%的比例选取目标企业，确保专项检查的针对性。一是聚焦节日保供产品。充分考虑节假日药品供需特点，紧盯奥司他韦、小儿氨酚黄那敏、诊断试剂等需求旺、用量大的药品器械产品，紧盯直接面对人民群众的终端环节，集中力量对保供药械生产企业、连锁总部及门店开展检查。二是聚焦集采中选药品医疗器械。切实维护集采政策落地见效，保障人民群众用上质优价廉的医药产品，本次检查将第十一批集采中选药品3家生产企业以及1家中选第三类器械生产企业全部纳入专项检查范围，做到对集采中选产品生产质量状况心中有数。三是聚焦特殊管理药品。特药监管无小事，必须绷紧神经，抓在经常。本次专项检查将麻醉药品、精神药品生产企以及经营企业作为检查重中之重，覆盖生产、销售、使用全链条，严格核验全流程监控措施，杜绝质量风险和流弊隐患。四是聚焦较高风险企业。针对2025年日常监督检查缺陷较多、隐患较大的企业，梳理重点检查企业清单，全部纳入专项检查，重点对上年度问题整改和隐患消除情况开展靶向性复查。经过筛选比对，最终确定检查对象16家。二、统筹调配检查力量，提升监管质效 打破常规责任分工，强化属地监管协同，创新人员调配模式，统筹安排专项执法人员，确保专项检查力量高效、专业。一是创新检查形式。以交叉检查为原则，结合企业许可事项合并检查、案件线索核查、舆情监测核查、质量风险核查等多元形式，提升检查针对性与实效性，其中交叉检查11家次、许可合并检查5家次、线索核查4家次、舆情核查2家次、风险核查1家次。二是优化人员配置。根据监管人员专业特长，选派所检查领域经验丰富的业务骨干担任组长，补充搭配擅长其他领域的组员，让检查组专业知识能够互补、检查视角更加立体，检查范围更加全面，有效提升了专项检查的纵深度和专业性。三是强化监管协同。本次专项检查联合市区市场监管部门组成联合检查组，对直接面对人民群众的药品零售连锁和门店开展协同检查，形成了监管合力，强化了监管权威。四是深化“以查代训”。通过“交叉互查、交叉互学”及向外地检查员取经的方式，既以客观严格标准排查隐患，又交流监管经验，实现执法能力与监管水平双向提升。 三、统筹布置检查事项，确保“多效合一”梳理岁末年初监管要求，打包安排多项检查任务，统筹布置专项检查事项，统一明确专项检查要求，实现一次检查、多重效果的监管目标。一是规范开展日常监督检查。将专项检查对象纳入2026年度日常监督检查计划，重点核查企业原辅料购进检验、生产工艺执行情况、车间规范管理、成品生产检验、储存养护等核心环节。本次检查首次使用规范的涉企行政检查文书，严格按照省局《药品行政检查文书格式文本（试行）》要求，规范出具检查通知书、检查报告，确保执法程序合法合规。二是提前开展集采中选药品生产监管。集采中选结果公布后，在省局下达中选药品上市前监管任务之前，本次专项检查就已经启动集采中选药品的监管工作，重点核查是否严格按照核准工艺规程生产，现已提前完成省局部署的2026年度集采药品中选企业生产监管任务，确保集采药品上市前全面符合生产条件。三是精准开展上年度日常监管“回头看”。本次专项检查将2025年度监督检查发现问题的整改情况作为现场核查的重要内容，现场对照既往问题清单逐项核查整改落实情况，督促企业将整改措施落到实处，坚决杜绝“纸上整改”。四是严肃开展上年度工作纪律廉政回访。把年初抽取一定数量监管对象开展廉政回访作为分局坚持的廉政制度。将本次专项检查对象全部纳入廉政回访对象，采取交叉的形式对分局执法人员上一年度现场检查纪律执行情况开展回访，要求检查记录详细记载廉政回访情况，进一步筑牢执法廉洁防线。下一步，宜昌分局将持续巩固专项检查成果，重点推进三方面工作：一是常态化开展问题整改“回头看”，跟踪整改进度，确保风险隐患动态清零。二是加强春节期间应急值守，提升突发情况响应处置能力。三是持续强化药品全链条监管，切实保障辖区群众用药安全、有效、可及，全力护航节日期间药品安全形势稳定。（信息来源：宜昌分局）

为加快推进新版《医疗器械生产质量管理规范》（以下简称《规范》）在湖北省全面贯彻实施，近日，湖北省药监局印发《实施方案》，部署《规范》实施工作。《实施方案》坚持“全面部署、分类指导、系统推进、整体提升”的工作原则，通过系统性组织、整体性推进，确保全省医疗器械注册人、备案人及受托生产企业全面理解、准确掌握新版《规范要求》，并于2026年11月1日前完成质量管理体系全面升级，实现监管部门监管能力和企业质量管理水平双提升，进一步夯实产业发展基础。省药监局成立新版《规范》推进实施工作专班，明确各单位职责分工，共同推进新版《规范》实施工作。《实施方案》紧扣国家药监局相关要求和湖北省产业发展实际，按照“动员部署与宣贯培训、企业自查与整改升级、指导帮扶与抽查核查、全面实施与巩固提升”等4个阶段压茬推进，倒排工期，精准施治。一是压实企业责任。要求各医疗器械企业制定并执行全员培训计划，成立工作小组，制定详细的整改计划，明确时间表、责任人和整改措施，确保按期完成整改提升任务。二是鼓励先试先行。鼓励集采类、植入类、质量管理体系基础较好的企业先试先行，提前开展相关评估提升工作，率先完成新版《规范》的提档升级。三是坚持示范引领。抓好典型示范，选择基础较好、管理规范的企业作为示范标杆，适时组织开展经验交流，发挥示范效应，促进行业共同提升。四是强化督导检查。组织专业人员深入产业园区和重点企业，开展答疑和帮扶，对企业自查整改情况按比例抽查，采取清单式销号管理，确保整改与督查形成工作闭环。下一步，湖北省药监局将加大新版《规范》的宣贯培训、指导帮扶和督导检查力度，指导企业针对性开展自查评估和整改提升，压实企业质量安全主体责任，严格依法查处各类违法违规行为，确保新版《规范》如期全面顺利实施，实现医疗器械产业高质量发展和高水平安全良性互动。（信息来源：医疗器械化妆品监管处）

为贯彻落实省委、省政府关于脑机接口技术和产业发展的决策部署，助力开辟未来产业新赛道，2月2日，省药监局组织医疗器械注册管理处、省医疗器械检测中心、省药品认证审评中心相关负责人及业务骨干组成创新服务工作专班，赴江西脑虎科技有限公司开展现场帮扶。江西脑虎科技有限公司在脑机接口领域已构建全链条自主研发体系，实现实时汉语及运动解码双重突破，其高通量脑机接口系统医疗器械项目被列入省药监局年度重点帮扶计划。工作专班通过实地考察、座谈交流等方式，详细了解了该项目的技术优势和临床价值，精准对接企业在成果转化过程中遇到的堵点、难点问题，并依据职责安排专人对该公司的体系建设、临床研究、检验检测及临床试验等环节提供全程跟踪服务，全力助推项目加快落地。下一步，省药监局将持续聚焦医疗器械产业创新发展方向，以创新服务工作专班为重要抓手，支持我省企业前瞻布局未来产业新赛道，促进科技创新和产业创新深度融合，加快培育新质生产力，全力推动我省未来产业发展不断取得新突破，为“十五五”时期全省经济社会高质量发展贡献更大力量。（省药监局医疗器械注册管理处供稿）

Delivery Method:VIA Electronic MailProduct:Medical DevicesRecipient:Daihanna PeñaSenior Director, Plant OperationsUnomedical Device S.A. de C.V.Parque Ind. Del Norte., Ave.Formento Ind. Lote 9, Sec. 3Reynosa,Tamps.Mexico(b)(6)@convatec.comIssuing Office:Center for Devices and Radiological HealthUnited StatesWARNING LETTERCMS #719428January 8, 2026Dear Ms. Peña:During a Remote Regulatory Assessment of your firm located in Reynosa, Tamaulipas, Mexico from July 23, 2025 through August 8, 2025, an investigator from the United States Food and Drug Administration (FDA), reviewed the records you submitted in response to our May 22 and June 6, 2025, requests for records and other information pursuant to section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) for your facility, determined that your firm manufactures insulin infusion sets for subcutaneous insulin delivery in diabetic patients. These infusion sets are sold under the Unomedical brand name and are also distributed under other brand names including, but not limited to, MiniMed Mio, MiniMed Mio 30, MiniMed Silhouette, MiniMed Sure-T, MiniMed Quick-Set, MiniMed Mio Advance, Extended Wear Infusion Set, i-port ADVANCE, and Convatec’s inset and contact detach infusion sets for use with compatible third-party insulin pumps. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or function of the body.Quality System Regulation ViolationsThis inspection revealed that these devices are adulterated within the meaning of section 501(h) of the Act, 21 U.S.C. § 351(h), in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of your device are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at Title 21,Code of Federal Regulations(CFR), Part 820. We received your responses dated August 29, 2025, September 29, 2025, and November 14, 2025 concerning our investigator's observations noted during the Remote Regulatory Assessment which were issued to your firm.We address these responses below, in relation to each of the noted violations. These violations include, but are not limited to, the following:1) Failure to validate processes whose results cannot be fully verified by subsequent inspection and test, as required by 21 CFR 820.75(a). For example, the water leak test method used for in-process and final inspection, complaint investigations, and for tests performed during validations and revalidations has not been validated according to your firm's own procedures, despite being critical for detecting leaks in the insulin infusion sets that could cause insulin under-delivery and diabetic ketoacidosis. Between January 2023 and June 2025, your firm has received more than 5,000 complaints related to leaking of infusion sets, where patients experienced hyperglycemia with diabetic ketoacidosis. The Work Instruction # 3806111, "Validation of Test Methods (TMV)," version 9.0, effective February 10, 2025, requires validation of the water leak tester to show that the test "can consistently and accurately differentiate between the possible test states"; however, Ms. Victoria Canela, CAPA Manager, stated that the water leak test has not been validated.We have reviewed your responses and conclude that they are not adequate. Your firm opened CAPA-2356512 to address this observation. Your firm provided Document No. M0666.0001, IQ/OQ/PQ Protocol for Validation of Test method for Leak in water Test, version 1.0. Your firm’s updated response states "This validation has been completed and was submitted as part of our initial response," however, the completed validation reports were not provided. The protocol includes(b)(4). However, the protocol does not describe how appropriate statistical methods for data collection and analysis are used nor define the criteria for revalidation. Your firm should revise your protocol to include(b)(4). The revised protocol should be provided for review. When available, your firm should also provide the completed validation reports. Your firm also plans to update the Test Method Validation procedure to add test method validation for all test methods and equipment used in product release, complaint investigations, and validation/revalidation activities by October 31, 2025. The revised procedure should be provided for review.Finally, your firm plans to conduct a systematic review of all inspection and test equipment used for product release, complaint investigations, and validation/revalidation activities to identify any other unvalidated processes or equipment and remediate as needed by December 31, 2025. Your firm should ensure your review includes all manufacturing processes, including test methods, to ensure that any process which cannot be fully verified is validated. Your firm should provide the results of your systematic review, identifying the processes and test methods assessed and their validation status. If additional validations are needed your firm should provide a copy of the validation protocols, and if available, final reports.2) Failure to adequately review and investigate complaints involving the possible failure of a device to meet any of its specifications, as required by 21 CFR 820.198(c). For example:a. Your firm's complaint handling procedure, Document 3709030, Complaint handling, versions 12 - 19, effective July 22, 2020 – December 18, 2024 (current) allowed the closure of over 41,000 "Type 1" complaints, received between June 2023 and June 2025, without investigation, because lot numbers were missing. These uninvestigated complaints included allegations of leakage, loss of physical integrity, adhesive failures, infections, and death (Complaint 2204208).b. In Complaint 2204208, a patient died with a blood glucose of 1.1. The customer provided the pump serial numbers, transmitter numbers, and material numbers for the reservoir and sensor, however your firm did not investigate because no lot number was provided and no attempt to collect the lot number was documented. The customer agreed to return product, but no effort to obtain the device was documented.We have reviewed your responses and conclude that they are not adequate. Your firm initiated CAPA-2356421 to address this observation. While your firm acknowledges procedural deficiencies and has initiated some corrective actions including reopening complaints 2204208, 1997347, and 2051281, and conducting vigilance training (Document: Infusion Care Complaint Vigilance Awareness Refresher TrainingAttendance25SEP2025.pdf), the corrective actions are still pending. But your firm has not included a plan to address devices which do not conform to specifications which have already been distributed. Specifically, your firm’s plans do not include assessing the risk of distributed products and plans to notify or correct those distributed products which may include any user notifications, corrections, or removals of product already distributed that may be necessary to prevent a risk to health.We acknowledge that in your November 14, 2025 response your firm submitted revised complaint handling procedures and work instructions, however, your firm has not yet provided evidence of implementation of these corrective actions and your firm also plans to conduct a retrospective review of using its revised procedures on complaint data involving leakage, loss of physical integrity, adhesive failure, and infection, and those coded as “cannot be determined” or “no malfunction” received since June 1, 2023, and remediate as needed, by March 2026.It is unclear if this retrospective review will include all complaints involving the possible failure of the device, labeling, or packaging to meet any of its specifications. Your firm should provide a justification for the sample size selected for the retrospective review. Your firm should provide the results of the retrospective review.Your firm also plans to conduct a retrospective trend analysis to identify trends for each reported complaint issue by May 2026. The results of this review should be provided. Furthermore, your firm plans to conduct a retrospective review of complaints involving serious injury and/or death and remediate as needed by January 2026. Your firm also plans to conduct additional training regarding product specific information, complaint handling by May 2026. Your firm also plans to implement procedures to regularly audit complaint and “non-complaint” records by February 2026. The procedure and evidence of retraining should be provided for review.3) Failure to establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a). For example:a. CAPA 1627223 was initiated on February 23, 2023 to address a trend in complaints received for leaking Inset I and Inset II infusion set products. The investigation concluded that the root cause was(b)(4), specifically involving(b)(4)(affecting all manufacturing lines). Corrective actions were implemented (including(b)(4)) and the CAPA was closed as effective on March 14, 2025 based on a review of complaints received from 2023 and 2024 related to leaks; however, the effectiveness review was only based on a one month search of complaints and, as indicated in item two above, your firm excluded the 41,000 uninvestigated Type 1 complaints in its verification. Furthermore, the verification of effectiveness did not take into consideration whether leak failures were identified through the nonconformance process to ensure the investigation scope and root causes were adequate. Specifically, while CAPA 1627223 was in progress (Feb 2023 - Mar 2025), your firm continued to document the following seven nonconformance reports related to leak failures on Inset I and II products:Nonconformance NumberDate InitiatedPart AffectedDescription(b)(4)(b)(4)(b)(4)Inset: Leakage in water test Failure(b)(4)(b)(4)(b)(4)Inset: Leak failure on(b)(4)(b)(4)(b)(4)(b)(4)Leak on membrane in(b)(4)product(b)(4)(b)(4)(b)(4)(b)(4)Leakage in water test failure on batch(b)(4)Product(b)(4)(b)(4)(b)(4)Failure in leak test test in water(b)(4)Product(b)(4)(b)(4)(b)(4)Failure on the leak test in water.(b)(4)(b)(4)(b)(4)Failure on the leak test in water.b. Between December 12, 2022, and October 12, 2023, your firm received 210 complaints reporting the Varisoft infusion set tubing detached from the connector resulting in a high blood glucose level, including 86 with reported harm of hyperglycemia. However, your firm determined a CAPA was not needed even though complaints, such as 1593110 and 1619522 were categorized as severity 5 (death or life-threatening harm which requires professional medical intervention) until August 2023 (CAPA 1723998) following a supplier corrective action report due to complaints that Varisoft infusion sets have easily detached from the connector and/or patient line separation. This led to a Class I Recall (FDA RES 93269) initiated on October 11, 2023, more than 11 months after your firm became aware of the product defect. CAPA 1723998 concluded that the product defect was caused by a defective manufacturing machine, corrective actions were implemented, and the CAPA was closed as effective on May 5, 2025, stating “It was found 4 complaints received after the corrective action however after quality analysis on retention samples the failure was not confirmed. Therefore, it can be concluded that the CAPA was effective.” However, review of complaint data revealed approximately 180 complaints were received during the same period used for verification of effectiveness (April 2023 – August 2024), that reported Varisoft infusion set tubing detaching from the connector, including approximately 80 complaints reporting hyperglycemia. These complaints were not included in the verification check because, as indicated in item two above, your firm’s complaint handling process inadequately categorizes and investigates complaints alleging failure of the device.c. CAPA 2010953 was initiated on February 7, 2025, to address a trend of increasing complaints related to over 3,000 complaints of leaking of Extended Wear Infusion Sets (EWIS). The root cause was found to be that your firm did not conduct(b)(4)verification for the(b)(4)requirements to ensure the infusion set “stays on the patient for a usage time according to intended use after insertion”. The investigation also revealed that “(b)(4)”. The CAPA explains there is “(b)(4)…It is not clear which(b)(4)”. However, your firm failed to identify any corrective actions to address these device design deficiencies, and the only proposed corrective action is to update the(b)(4)”. Additionally, CAPA 2010953 was limited to the EWIS products; however, your firm identified that all other product families also do not have(b)(4). Furthermore, your firm’s Design Risk Assessment for the EWIS products, Document 3A02087 indicates that potential harm to patients(b)(4)as 5 (Life threatening or may result in death or disability of patient); however, your firm did not evaluate the potential impact to patients from defective products in the field.d. CAPA 1832980 was initiated on February 21, 2024, to address complaint handling process deficiencies including miscategorized and incorrectly coded complaints. Corrective actions, including remediating complaint records were initiated in April 2024. Complaint numbers 1997347 and 2051281 which were received based on reports of “leaking at the site.” The records document that they had been remediated as part of CAPA 1832980; however, the complaints remain incorrectly coded as: Reported Complaint Issue = “Cannot be determined” and Malfunction Code = “No malfunction based on complaint information”.e. CAPA 1668046 documented that the Inset Guard Ramp-Up product family failed to meet design requirements, including Product Requirement 110.14 ("(b)(4)"), yet your firm closed this CAPA as effective in April 2025 after implementing a "new" test method. However, complaint data shows your firm continued to receive approximately 5,000 complaints reporting leakage of Inset Guard Ramp-Up products through June 2025, including reportable malfunctions and serious injuries, indicating that the design verification testing remains inadequate.We have reviewed your firm’s responses and conclude that they are not adequate. Your firm initiated CAPA-2356496 to address this observation. While your firm acknowledges CAPA deficiencies and has initiated some corrective actions including establishing(b)(4)starting August 27, 2025 (Documents: Meeting Minutes 27 Aug 2025, 10 Sep 2025, 24 Sep 2025),(b)(4)SOP 3702002 (Corrective and Preventive Action) and related procedures, the corrective actions are still pending. But your firm has not included a plan to address devices which do not conform to specifications which have already been distributed. Specifically, your firm's plans do not include assessing the risk of distributed products from the inadequately investigated CAPAs and any corrections or removals of product already distributed that may be necessary to prevent a risk to health.Your firm plans to complete reassessment of CAPAs 1627223, 2152419, and 2010953 by December 2025, with CAPA 2010953 sent back to investigation on September 22, 2025. Your firm should submit the completed CAPA investigations with verified root causes and objective evidence of effective corrective actions for review.Your firm also plans to conduct a retrospective review of product-related CAPAs closed since June 1, 2023, to ensure adequate verification of effectiveness and reopen as required by March 2026. However, it is unclear if this retrospective review will include assessment of distributed products that may require field action. Your firm should provide a justification for the scope and timeline of the retrospective CAPA review. Your firm should provide the results of the retrospective review.Your firm also plans to(b)(4)by March 2026. The results of(b)(4)should be provided. Furthermore, your firm plans to implement(b)(4)to monitor CAPA progress by October 2025. Your firm also plans to establish a(b)(4)by November 2025 and(b)(4)by December 2025. The revised procedures should be provided for review.Medical Device Reporting (MDR) Violations1. Failure to report the information required by § 803.52 in accordance with the requirements of § 803.12(a), no later than 30 calendar days after the day that your firm received or otherwise became aware of information, from any source, that reasonably suggests that a device that your firm markets may have caused or contributed to a death or serious injury, as required by 21 CFR 803.50(a)(1). For example, the information included for Complaint 1997347 reasonably suggests that four of your firm’s AutoSoft XC infusion sets malfunctioned (i.e. device leakage) during use, resulting in elevated blood glucose readings (hyperglycemia) that required the administration of a corrective bolus via the pump. We believe this medical intervention was necessary to prevent permanent impairment of a body function or permanent damage to a body structure. Therefore, each of these four events meets the definition of a reportable serious injury under 21 CFR 803.3. Your firm became aware of these events on September 4, 2024, but failed to submit the corresponding MDR for each of the four reportable serious injury events.We reviewed your firm’s response dated August 29, 2025, and conclude that it is not adequate. In the response, your firm acknowledged the observations and stated that they have initiated a comprehensive plan to address each of the observations. However, your firm did not provide a specific plan describing how the issue will be addressed, nor did they provide a timeline for completion.The adequacy of your firm’s response dated September 29, 2025, cannot be determined at this time. The response states that your firm plans to revise its complaint handling and reporting process to address the issue, complete staff training, and will conduct a retrospective review of complaints and submit any newly identified MDRs as appropriate. However, your firm has not provided documentation or evidence to demonstrate that these systemic corrective actions have been fully implemented, including completion of the retrospective review, as these activities are still ongoing.We acknowledge that your firm’s response dated November 14, 2025 included revised complaint handling and reporting procedures and work instructions, however, your firm has not provided evidence of implementation of these new procedures such as training and has not provided the results.2. Failure to report the information required by § 803.52 in accordance with the requirements of §803.12(a), no later than 30 calendar days after the day that your firm received or otherwise became aware of information, from any source, that reasonably suggests that a device that it markets has malfunctioned and this device or a similar device that your firm markets would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur, as required by 21 CFR 803.50(a)(2). For example, the information for Complaint 2051281 reasonably suggests that two of your firm’s AutoSoft XC infusion sets malfunctioned (i.e. device leakage) during use. The serious injury MDR 3003442380-2024-05425, resulting from the same malfunction for the same device, has in the past caused or contributed to a serious injury, thereby establishing precedent that the malfunction would be likely to cause or contribute to a death or serious injury if it were to recur. There is no information included for the complaint that justifies that the referenced malfunction would not be likely to cause or contribute to a death or serious injury. Therefore, the information included for the referenced event represents a reportable malfunction under 21 CFR 803.3. Your firm became aware of these events on October 29, 2024, but failed to submit the corresponding MDR for each of the two reportable malfunction events.We reviewed your firm’s response dated August 29, 2025, and conclude that it is not adequate. In the response, your firm acknowledged the observations and stated that they have initiated a comprehensive plan to address each of the observations. However, your firm did not provide a specific plan describing how the issue will be addressed, nor did they provide a timeline for completion.The adequacy of your firm’s response dated September 29, 2025, cannot be determined at this time. The response states that your firm plans to revise its complaint handling and reporting process to address the issue, complete staff training, and will conduct a retrospective review of complaints and submit any newly identified MDRs as appropriate. However, your firm has not provided documentation or evidence to demonstrate that these systemic corrective actions have been fully implemented, including completion of the retrospective review, as these activities are still ongoing.We acknowledge that your firm’s response dated November 14, 2025 included revised complaint handling and reporting procedures and work instructions, however, your firm has not provided evidence of implementation of these new procedures such as training and has not provided the resultsOther federal agencies may take your compliance with the FD&C Act and its implementation regulations into account when considering the award of federal contracts. Additionally, should FDA determine that you have Quality System regulation violations that are reasonably related to premarket approval applications for Class III devices, such devices will not be approved until the violations have been addressed.Please notify this office in writing within fifteen (15) business days from the date you receive this letter of the specific steps your firm has taken to address the noted violations, including an explanation of how your firm plans to prevent these or similar violations from occurring again. Include documentation of the corrections and/or corrective actions (which must address systemic problems) that your firm has taken. If your firm's planned corrective actions will occur over time, provide a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Please provide English translations of any documentation that is not in English to facilitate our review. We will notify you regarding the adequacy of your firm's responses and we may inspect your facility to verify that the appropriate corrections and/or corrective actions have been made. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration as part of your response.Your firm's response should be sent via email CDRHEnforcement@fda.hhs.gov. Please include in the subject line: "CMS Case #719428" when replying. If you have any questions about the contents of this letter, please contact Ghazaleh Esmaili at Ghazaleh.esmailit@fda.hhs.gov.Finally, this letter is not intended to be an all-inclusive list of the violations at your firm's facility. It is your firm's responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the observations communicated at the conclusion of the Remote Regulatory Assessment may be symptomatic of serious problems in your firm's manufacturing and quality management systems. Your firm should investigate and determine the causes of any violations and take prompt actions to correct them and bring your devices into compliance.Sincerely,/S/Courtney H. Lias, Ph.D.DirectorOHT7: Office of In Vitro Diagnostic DevicesOffice of Product Evaluation and QualityCenter for Devices and Radiological HealthCC:Courtney SmithU.S. AgentCourtney.smith@convatec.com

Delivery Method:Via Electronic Mail - Return Receipt RequestedReference #:320-26-39Product:Drugs、Over-the-Counter DrugsRecipient:Mr. Eric Jon GripentrogChief Executive OfficerHTO Nevada, Inc. dba Kirkman6400 Rosewood StreetLake Oswego,OR97035-5392United StatesIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter320-26-39January 27, 2026Dear Mr. Gripentrog:The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, HTO Nevada, Inc. dba Kirkman, FEI 3004268965, at 6400 Rosewood Street, Lake Oswego, from August 18 to 22, 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 September 12, 2025, response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence. Your response is inadequate because, while you indicate that you will no longer manufacture drugs, you did not provide adequate corrective actions and preventive actions (CAPA) for the violations, including addressing whether the drug products will be removed from the market.During our inspection, our investigators observed specific violations including, but not limited to, the following:1. 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 is a contract manufacturer of over-the-counter (OTC)(b)(4)drug products. Your quality unit (QU) did not adequately oversee your drug manufacturing operations. For example, your QU failed to ensure:Adequate change control procedures, because after reformulating(b)(4)drug products with a new API, your QU released and distributed batches of these drug products with inaccurate labeling, still showing the previous active pharmaceutical ingredient (API). Specifically,(b)(4)was listed on the product labeling, when the drug product actually contained the reformulated API,(b)(4). Thus, your drug product label to contain(b)(4)actually contained(b)(4)(21 CFR 211.22(d)).Appropriate oversight for contract testing laboratories regarding qualification, method validation, and written agreements describing roles and responsibilities (21 CFR 211.22(a) and 211.22(b)).Performance of periodic production review at least annually (21 CFR 211.180(e)).Your firm’s quality systems are inadequate. See FDA’s guidance documentQuality Systems Approach to Pharmaceutical CGMP Regulationsat https://www.fda.gov/media/71023/download for help with implementing quality systems and risk management approaches to meet the requirements of CGMP regulations (21 CFR, parts 210 and 211).In response to this letter, provide a risk assessment regarding the change in the active ingredient for(b)(4)drug products.2. 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)).You lacked process validation data to demonstrate that you have adequately validated the manufacturing processes for drug products. Additionally, your procedures and batch records lack parameters, such as(b)(4), that may impact the quality of your drug products. Furthermore, you failed to adequately qualify and test your(b)(4)system, which is used in the manufacture of the drug products. For example, you did not test your(b)(4)system for(b)(4).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 and must 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 is necessary to ensure that you maintain a stable manufacturing operation throughout the product lifecycle. See FDA’s guidance for industry,Process Validation: General Principles and Practicesat https://www.fda.gov/media/71021/download for general principles and approaches that the FDA considers appropriate elements of process validation.In response to this letter, 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 detailed risk assessment addressing the potential effects of the observed(b)(4)system failures on the quality of all drug product lots currently in U.S. distribution and within expiry. Specify the actions you will take in response to the risk assessment, such as customer notifications and product recalls.3. Your firm failed to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products (21 CFR 211.166(a)).Your firm failed to establish an adequate stability program with data from long-term or accelerated storage conditions, demonstrating that the drug products remain acceptable throughout the labeled expiry period. The stability protocol provided was an incomplete 24-month stability report for(b)(4)that lacked recorded results and the appropriate signatures. Without the appropriate stability studies, you do not have adequate scientific evidence to support that your drug product retains its quality attributes throughout the labeled(b)(4)expiry period.In response to this letter, provide:A retrospective risk assessment showing how you will ensure that marketed drug products meet stability specifications throughout their shelf life.A comprehensive, independent assessment and CAPA plan to ensure the adequacy of your current 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 to the program each year, to determine if the shelf-life claim remains valido A detailed definition of the specific attributes to be tested at each station (time point)All procedures that describe these and other elements of your remediated stability program.A summary of all results obtained from testing retain samples using your remediated stability protocols from each batch. If such testing reveals substandard quality drug products, take rapid corrective actions, such as notifying customers and product recalls.Repeat Observations at FacilityIn a previous inspection, dated March 19, 2019, FDA cited similar CGMP observations. You proposed specific remediation for these observations in your response. Repeated failures demonstrate that executive management oversight and control over the manufacture of drugs is inadequate.CGMP Consultant RecommendedBased upon the nature of the violations we identified at your firm, you should engage a consultant qualified as set forth in 21 CFR 211.34 to evaluate your operations and to assist your firm in evaluating products that remain in distribution.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.Drug Production CeasedWe acknowledge your commitment to cease production of all drugs at this facility for the U.S. market. In response to this letter, clarify whether you intend to resume manufacturing any drugs at this facility in the future.If you plan to resume any manufacturing operations regulated under the FD&C Act, notify this office before resuming your drug manufacturing operations. You are responsible for resolving all deficiencies and systemic flaws to ensure your firm is capable of ongoing CGMP compliance. In your notification to the Agency, provide a summary of your remediations to demonstrate that you have appropriately completed all corrective action and preventive action (CAPA).Additionally, you remain responsible for the products on the U.S. market through their expiry date, which includes ensuring that you have adequate stability data to support these marketed products.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 3004268965 and ATTN: Christopher Jenner.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and Research

Delivery Method:VIA Electronic MailProduct:Medical DevicesRecipient:Mr. Vincent MadhavanGeneral Manager/Sr. Director of QualityFlextronics America LLC12455 Research Blvd, Bldg. GAustin,TX78759United States(b)(6)@flex.comIssuing Office:Center for Devices and Radiological HealthUnited StatesWARNING LETTERCMS 7221801/27/2026Dear Mr. Madhavan,During an inspection of your firm located in Austin, TX from October 20 through October 30, 2025, investigators from the United States Food and Drug Administration (FDA) determined that your firm contract manufactures the(b)(4)Continuous Glucose Monitor (CGM). Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.Quality System Regulation ViolationsThis inspection revealed that these devices are adulterated within the meaning of section 501(h) of the Act, 21 U.S.C. § 351(h), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at Title 21,Code of Federal Regulations(CFR), Part 820.We received responses from you dated 11/20/2025 and 12/19/2025 concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, that was issued to your firm. We address these responses below, in relation to each of the noted violations. These violations include, but are not limited to, the following:1. Failure to adequately ensure that when the results of a process cannot be fully verified by subsequent inspection and test that the process shall be validated with a high degree of assurance and approved according to established procedure, as required by 21 CFR 820.75(a).For example: During puck assembly of the(b)(4)sensor,(b)(4)are used load PCBAs onto the(b)(4). These(b)(4)must move the PCBA along all(b)(4)((b)(4)) to make this transfer. The(b)(4)determines the(b)(4)of the part and therefore has potential affect (in part) on both the(b)(4). Your firm’s employees observed sensor damage after this transfer and provided evidence they often had to make(b)(4)adjustments. Review of the assembly process validation on the(b)(4)lines used in the manufacture of the sensor pucks found no defined setting or acceptable range for the equipment used to(b)(4)set or change the(b)(4).As described, uncontrolled(b)(4)can result in damaged and nonconforming product. Therefore, this parameter must be controlled as part of your process validation. The Installation Qualification Protocol and associated reports for the(b)(4)Puck Assembly machines do not define any specifications or set up activities for the(b)(4)of the(b)(4)puck(b)(4), or related acceptance criteria.Over four years of(b)(4)manufacturing,(b)(4)have caused damage or failed to pick up parts, requiring corrective maintenance to adjust(b)(4). FDA investigators observed approximately(b)(4)corrective maintenance activities for puck(b)(4)and(b)(4)since 2021. Records describe parts being damaged or not picked up, with adjustments made without established specifications or controls. For example, REQ-1204527 documents turning "(b)(4)," then running cycles until "(b)(4)" before resuming manufacturing.Therefore, associated process validation for the puck assembly process does not demonstrate your process consistently produces product according to your predetermined specifications.The adequacy of your firm's response cannot be determined at this time. Your response confirms "(b)(4)verified the presence of the system manual but did not mandate verification of operation and maintenance instructions for sub-components like the(b)(4). This oversight resulted in the absence of specific, detailed(b)(4)specifications and maintenance procedures for the(b)(4)." Your firm stated that it has already designed a procedure and setup tool to facilitate(b)(4)alignment, reassessed PFMEA severity ratings, and evaluated(b)(4)equipment validations to ensure appropriate manuals are included. You plan to update qualification protocols and reports to qualify tool effectiveness, update the alignment procedure, and ensure documentation supports these activities. Your response (Attachment 14) indicates the tool or "(b)(4)" thickness now specifies the(b)(4)((b)(4)).Your responses to Observations 1 and 3 include plans to qualify the new(b)(4)and partially revalidate the process to determine effectiveness of the new(b)(4)specification. However, the Action Plan for Observation 1 states you plan to "Update the Qualification protocols/reports to formally qualify the use and effectiveness of the setup tool ((b)(4)) (Action 1.1) for Puck lines(b)(4)" but does not clearly state you intend to validate the process. Partial revalidation described under Observation 3 might be sufficient, but we cannot assess adequacy as it remains in progress without evidence from the revalidation. Please provide updates on revalidation activities as they progress and a summary with supporting documentation upon completion.2. Failure to adequately establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a).For example: Your firm did not adequately identify the actions needed to correct and prevent recurrence of nonconforming product and other quality problems.This cite is related to the quality problem identified in observation 1 where nonfunctioning devices were caused by improper alignment of the(b)(4)leading to impact to the leads of the connector causing the(b)(4)on the PCBA to break. After your firm opened a CAPA on 4/1/2025, it did not identify the actions needed to correct and prevent recurrence of broken components or(b)(4)connections due to lack of defined specification for the(b)(4). As a result, corrective maintenance requests to adjust the(b)(4)continued after your corrective actions were initiated.We reviewed your firm’s response and conclude that it is not adequate. Your firm’s initial response identified multiple corrective actions including but not limited to the need to strengthen guidance for: a) action plan implementation and verification as well as b) handling changes from approved action plans during implementation and verification. Specifically, your firm identified the need to “clarify the technical analysis”. The technical analysis conducted during the FDA-483 remediation identified that establishing a setpoint for the(b)(4)was critical. The procedural updates are an improvement, but implementation may be subjective for each situation in determining technical analysis (when needed and what is performed) and will have to be reviewed during a subsequent inspection to determine adequacy. Your firm did not include training records, and the status is still in progress. Please provide an update on the verification of effectiveness for this CAPA when it is available later this year.Your firm should take prompt action to address any violations identified in this letter. Failure to adequately address this matter may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties.Other federal agencies may take your compliance with the FD&C Act and its implementing regulations into account when considering the award of federal contracts. Additionally, should FDA determine that you have Quality System regulation violations that are reasonably related to premarket approval applications for Class III devices, such devices will not be approved until the violations have been addressed. Should FDA determine that your devices or facilities do not meet the requirements of the Act, requests for Certificates to Foreign Governments (CFG) may not be granted.Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to address the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (which must address systemic problems) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm’s response should be comprehensive and address any violations included in this Warning Letter. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration as part of your response.Your firm’s response should be sent via email to ORP EAT 3 Assistant Director Jeff Wooley at CDRHEnforcement@fda.hhs.gov. Please include in the subject line, “CMS Case 722180” when replying. If you have any questions about the contents of this letter, please contact: Lauren Priest at Lauren.Priest@fda.hhs.gov.Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of any violations and take prompt actions to address any violations and bring the products into compliance.Sincerely,/S/Barbara C. MarsdenActing DirectorOffice of Regulatory ProgramsOffice of Product Evaluation and QualityCenter for Devices and Radiological Health