各区市场监管局：《天津市自动售械机监督管理规定（试行）》已经2026年第2次局长办公会议审议通过，现予印发，请遵照施行。2026年6月9日（此件主动公开）天津市自动售械机监督管理规定（试行）第一章 总则第一条为鼓励医疗器械零售业态创新，方便群众购买医疗器械，规范本市自动售械机的监督管理，防范医疗器械质量安全风险，保障医疗器械质量安全，根据《医疗器械监督管理条例》《医疗器械经营监督管理办法》《医疗器械经营质量管理规范》等有关规定，结合本市实际，制定本规定。第二条天津市行政区域内设置自动售械机从事医疗器械零售经营活动及其监督管理，应当遵守本规定。第三条本规定所称自动售械机，是指在无人值守场景下，通过硬件设施与软件系统，实现医疗器械自助选购、支付及取货，或线上下单、线下自取/配送的销售设备。自动售械机作为医疗器械零售经营场所的延伸，其经营活动应当纳入医疗器械经营质量管理体系。第四条设置自动售械机从事医疗器械零售经营活动的经营者，应当依法承担医疗器械质量安全责任，对自动售械机的管理及其所经营医疗器械的质量安全负责。第五条天津市药品监督管理局负责指导全市自动售械机的监督管理工作。各区市场监督管理局负责本行政区域内自动售械机的监督管理工作。第二章 经营许可与备案管理第六条通过设置自动售械机从事第三类医疗器械和第二类医疗器械零售经营活动的企业，应当依法取得医疗器械经营许可或完成医疗器械经营备案。自动售械机的经营范围不得超出企业经营许可或备案的范围，其运营期限不得超过医疗器械经营许可证的有效期，且企业的经营方式应当包含“零售”或者“批零兼营”。外省市企业在本市行政区域内设置自动售械机的，应当在本市依法取得医疗器械经营许可或备案，并遵守本规定。仅销售第一类医疗器械和免于经营备案第二类医疗器械的除外。第七条首次申请医疗器械经营许可或办理经营备案的企业，可同时申请设置自动售械机，作为医疗器械零售经营场所之一。已经取得《医疗器械经营许可证》《第二类医疗器械经营备案凭证》的企业，申请设置、增加、减少或取消自动售械机的，应当按照经营场所变更的有关规定，向企业所在地区市场监督管理局申请许可变更或办理备案变更。第八条企业设置自动售械机，应当依据《医疗器械经营监督管理办法》等相关规定，向企业所在地区市场监督管理局申请许可变更或办理备案变更，并提交下列资料：（一）自动售械机设置场所信息列表，以及对应的地理位置图、平面图、房屋产权文件或租赁协议复印件；（二）主要经营设施、设备目录；（三）自动售械机管理制度、工作程序等文件目录；（四）自动售械机计算机管理系统情况说明；（五）经办人授权文件。企业首次申请医疗器械经营许可或办理经营备案同时设置自动售械机的，应当同时提交前款规定的全部资料。已取得《医疗器械经营许可证》或《第二类医疗器械经营备案凭证》的企业，申请增加自动售械机的，可免予提交第（二）（三）（四）项材料；减少或取消设置自动售械机的，仅需提交第（五）项材料。企业应当确保提交的资料合法、真实、准确、完整且可追溯。第九条企业所在地区市场监督管理局应当按照《医疗器械经营监督管理办法》等规定，及时办理经营备案或许可的审批、变更手续，必要时按照医疗器械经营质量管理规范和本规定的要求开展现场核查。第十条自动售械机设置信息应当在医疗器械经营许可证或备案凭证中予以登载，格式为：“设置自动售械机，详见《天津市自动售械机设置场所登记表》（见附件）。”《天津市自动售械机设置场所登记表》与医疗器械经营许可证或备案凭证共同使用，作为企业经营场所的有效证明。登记表中的设置场所应当具体到街道门牌号及设置单位的楼层、房间。同一场所内设置多台自动售械机的，应当逐一编号。第三章 经营质量管理第十一条设置自动售械机从事医疗器械零售经营活动，应当遵循以下要求：（一）对所属自动售械机应当实行统一企业标识、统一设备管理、统一质量管理制度、统一计算机管理系统、统一采购配送、统一票据管理、统一售后服务等；（二）按照医疗器械经营质量管理规范的要求，建立包括贮存（陈列）、效期管理、出货、取货、销售、信息展示、售后服务、设备维护等覆盖自动售械机经营全过程的质量管理体系文件、工作程序和质量记录，记录内容应当真实、准确、完整和可追溯，确保医疗器械产品在自动销售特殊场景下的质量安全与可追溯。（三）具备与自动售械机设置规模、经营范围相适应的贮存及配送条件，配备质量管理、设备维护及售后服务等质量安全关键岗位人员，并为其履职提供必要的资源和制度保障，确保质量安全关键岗位人员充分履行职责。（四）计算机管理系统应当符合《医疗器械经营质量管理规范》要求，能够对每台自动售械机实行一机一号联网管理，实现与经营主体本部管理系统互联互通，实时交互自动售械机的相关数据；（五）根据医疗器械产品说明书要求，建立适宜通过自动售械机零售经营产品目录（注明医疗器械分类编码和产品名称）；（六）建立自动售械机管理档案，至少包括每台自动售械机的品牌型号、合格证明、设置时间、地点、维护维修记录等内容；（七）定期对自动售械机陈列、存放的医疗器械进行检查，重点检查产品外观、有效期等。发现存在质量疑问的，应当立即停止销售、撤出设备，交由质量管理人员确认和处理，并保留相关记录。第十二条经营者设置自动售械机的位置、数量等应当与其管理能力相适应，并符合以下要求：（一）放置场所应当取得房屋或场所合法使用资格，放置地点应当环境整洁卫生，避免日晒雨淋，不得与有毒、有害、有污染的物质同场所存放，不得设在户外、居民住宅、军事管理区（不含可租赁区）及其他不适合经营的场所，并需具备保证所陈列医疗器械质量安全的相应条件和措施；（二）自动售械机设备应当采用全封闭式设计，并配备温湿度监测设备或仪器；其内部陈列环境应当符合所经营医疗器械说明书或标签标示的贮存要求，产品摆放整齐有序；经营需冷藏、冷冻管理的医疗器械，应当符合医疗器械冷链管理有关规定，并具备温湿度自动监测、显示、记录、调控及报警等功能；（三）自动售械机的贮存、陈列、出货及取货方式，应当能有效防止产品的污染及破损；（四）自动售械机应当具备开具纸质或电子销售凭据的功能，零售第三类医疗器械应当具备生成销售记录的功能，销售凭据和销售记录应当符合相关规定要求；（五）在同一自动售械机内经营药品及其他产品时，应当分区陈列，与医疗器械区域明显隔离，设置醒目标志，类别标签字迹清晰、放置准确，并遵守药品及其他产品监管相关规定。第十三条自动售械机应当在醒目位置展示以下信息，且保证信息清晰、完整、不易脱落：（一）经营主体的《营业执照》《医疗器械经营许可证》或《第二类医疗器械经营备案凭证》等资质信息（可展示电子证照或清晰复印件），所展示信息应当真实有效；（二）“购买和使用前请仔细阅读产品说明书或者在医务人员指导下购买和使用”等警示用语。产品说明书中对贮存、运输及安全使用有特别说明的，还应当展示医疗器械产品说明书。（三）售后服务电话和投诉举报电话，同时应建立畅通的顾客意见反馈机制及退货等售后服务渠道。（四）鼓励企业利用电子触摸屏幕、手机APP或扫码等现代信息技术，以文本、图片或者链接标识等方式向消费者展示医疗器械产品资质、说明书等信息。相关展示信息应当与经注册或者备案的内容保持一致，并且清晰，容易辨识。相关信息发生变更的，应当及时更新展示内容。第十四条鼓励企业通过自动售械机销售终端、手机APP或扫码等方式收集、记录消费者反馈的医疗器械不良事件，并及时向医疗器械注册人、备案人及监测机构报告。第十五条企业应当将自动售械机经营质量管理情况纳入年度质量管理自查报告，并于每年3月31日前报送所在地的区市场监督管理局。第四章 监督管理第十六条各区市场监督管理局应当将设置自动售械机的经营企业列入年度监督检查计划，按照医疗器械经营企业分类分级监管要求，根据企业和产品风险等级，科学合理确定检查频次，减少重复检查。各区市场监督管理局应当通过合并检查、联合检查、书面核查、信息共享、智慧监管等监管方式，对企业的质量管理体系运行情况和自动售械机的实际运营状况进行监督检查，大力推进精准检查，督促企业严格履行法定责任与义务。第十七条各区市场监督管理局应当将自动售械机经营情况纳入风险会商范畴。对监督检查、投诉举报、舆情信息、网络监测、不良事件监测、行政处罚等显示可能存在的风险信息，应及时研判分析，并可采取责任约谈、现场核查、监督抽检、飞行检查、行政处罚等监管措施。第十八条利用自动售械机通过互联网开展线上下单、线下自取/配送业务的，其线上下单环节涉及的信息发布、交易过程等，应当同时遵守药品互联网信息服务和医疗器械网络销售管理等有关规定。第十九条设置自动售械机从事第一类医疗器械和免于经营备案第二类医疗器械经营活动，应当符合医疗器械经营质量管理规范的要求。第五章 附则第二十条本规定相关内容与国家药品监督管理局新出台的医疗器械经营监管政策规定不一致的，从其规定。第二十一条本规定自2026年7月1日起施行，有效期至2031年6月30日。附件：天津市自动售械机设置场所登记表附件天津市自动售械机设置场所登记表                                                  第 页，共 页企业名称许可证/备案编号许可证有效期限统一社会信用代码序号设置场所（具体到街道门牌号及设置单位楼层、房间）登载日期备注发证部门（公章）：    注：本登记表与第三类医疗器械经营许可证、第二类医疗器械经营备案凭证共同使用。附件：天津市药品监督管理局关于印发《天津市自动售械机监督管理规定（试行）》的通知.doc| 相关政策| 相关报道

近日，自治区药监局、自治区医保局联合印发《宁夏回族自治区医疗器械跨部门会商管理机制》，进一步畅通两部门沟通协作渠道，构建常态化、制度化协同工作格局。跨部门会商管理机制明确了三大核心工作内容。一是建立联合会商制度，聚焦医疗器械全链条质量安全风险，根据工作需要召开专题会商，共同分析研判风险隐患，研究制定针对性防控措施，实现风险早发现、早预警、早处置。二是强化双向信息共享，两部门及时共享涉及企业信息、监管动态、监督抽检、不良事件监测、挂网采购等信息，提升数据资源利用效能。三是深化联合执法与案件查办协作，根据工作需要在日常监管、专项检查、投诉举报处置中加强联合执法，及时移送反馈违法违规线索，形成监管合力，提升执法效能。下一步，两部门将严格落实会商机制要求，加强沟通协作，共享监管信息，保障产业高质量发展和群众用械安全。

　　为贯彻落实《国家医疗保障局办公室关于开展智能监管改革试点的通知》（医保办函〔2025〕40号）有关要求，做好我省医保智能监管改革试点工作，进一步提升全省医疗保障基金智能化监管水平，引导定点医药机构及其工作人员精准掌握医保基金使用规则，有效推动监管关口前移，根据国家医保局公开发布的智能监管“两库”规则和知识点，现面向社会公开发布我省2026年第三批医疗保障智能监管规则库相关规则及其知识点。　　本次公开“手术项目未按规定折价收费”“超互联网医院药品支付范围”“药品限二线使用”“中药饮片单方使用不予支付”“中药饮片单复方均不予支付”共5类规则对应知识点明细（共计1255条），适用于全省所有定点医药机构。　　全省各级医保部门要切实强化智能审核规则的掌握与应用，引导辖区内定点医药机构接入并应用智能审核事前提醒功能。全省各定点医药机构可将智能监管“两库”置于本机构智能提醒等信息化系统中，也可以对接医保部门智能监管系统事前提醒功能模块，对医保基金使用行为开展自动提醒和自查自纠，将不合规的行为消除在“萌芽”阶段，从源头上减少使用医保基金违法违规行为发生。　　省医保局实行智能审核“两库”动态调整机制，定点医药机构对“两库”执行中的问题和意见建议可反馈至邮箱：QHJJJGC001@163.com。　　附件：1.第三批-1.手术项目未按规定折价收费　　　　　2.第三批-2.超互联网医院药品支付范围　　　　　3.第三批-3.药品限二线使用　　　　　4.第三批-4.中药饮片单方使用不予支付　　　　　5.第三批-5.中药饮片单复方不予支付青海省医疗保障局2026年6月9日

Delivery Method:VIA ELECTRONIC MAIL READ/DELIVERY RECEIPTProduct:DrugsRecipient:Rafael PadillaCEOFagron BVFascinatio Boulevard 3503065 WB RotterdamNetherlandsIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERWL # 724551May 12, 2026Dear Mr. Padilla: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 21, 2017, and most recently on November 22, 2025. From October 9, 2025, to November 5, 2025, FDA investigators inspected your facility, Fresenius Kabi Compounding, LLC dba Fagron Sterile Services, located at 20 Dan Rd, Canton, MA 02021. During the inspection, investigators 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 November 5, 2025. FDA reviewed your facility’s responses, dated November 26, 2025, December 1, 2025, and December 5, 2025, and acknowledge receipt of your subsequent correspondence. FDA further acknowledges that your firm initiated a voluntary recall on February 5, 2026, of various lots of drug products, within expiry, produced using (b)(4) IV Bags intended or expected to be sterile due to 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.B. Violations of the FDCAAdulterated Drug ProductsThe FDA investigators 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 investigators observed that:1. You exposed sterile drugs and materials to lower than ISO-5 quality air.Specifically, operators' arms blocked the first air to sterile vancomycin vials during reconstitution. Additionally, operators vigorously shook the vials during this process. This rapid movement likely disrupts the unidirectional airflow within the ISO 5 aseptic processing area, creating a contamination risk.2. You failed to perform adequate smoke studies under dynamic conditions to demonstrate unidirectional airflow within the ISO 5 area. Therefore, your products intended to be sterile are produced in an environment that may not provide adequate protection against the risk of contamination.Specifically, airflow visualization studies (i.e., smoke studies) do not accurately reflect the actual quantity and positioning of equipment, materials, and other components used during production. Consequently, it cannot be determined whether adequate, uninterrupted, unidirectional airflow is maintained throughout the aseptic drug production process.The FDA investigators 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 quality control unit failed to exercise its responsibility to ensure that drug products manufactured are in compliance with CGMP, and meet established specifications for identity, strength, quality and purity (21 CFR 211.22).2. You failed to thoroughly investigate any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed (21 CFR 211.192).3. You failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile (21 CFR 211.113(b)).4. You failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas (21 CFR 211.42(c)(10)(iv)).5. You 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)).6. You failed to maintain buildings used in the manufacture, processing, packing or holding of drug products in a good state of repair (21 CFR 211.58).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.C. Corrective ActionsWe have reviewed your facility’s responses to the Form FDA 483, dated November 26, 2025, December 1, 2025, and December 5, 2025. We also acknowledge your firm initiated a voluntary recall on February 5, 2026, of various lots of drug products, within expiry, produced using (b)(4) IV Bags intended or expected to be sterile due to lack of sterility assurance.We are unable to fully evaluate some of your corrective actions due to lack of adequate supporting documentation:1. Regarding your firm’s failure 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 processes:a. We acknowledge your interim and long-term corrective action plans to address deficiencies in your current (b)(4) process for intravenous fluid bags. We note your intention to (b)(4) and, if necessary, (b)(4)—are implemented and qualified. Once these planned enhancements are complete, and the revised process implemented, FDA will evaluate the adequacy and safety of your (b)(4) processes. This evaluation will include an assessment to ensure there is no adverse impact on the quality of drug components and finished drug products.b. Regarding your firm's failure to ensure that personnel monitoring practices (i.e., gloved fingertip and gowned (b)(4) sampling) provide meaningful results, we acknowledge your plan to modify SOP # FSSBOS-SOP-0014, Aseptic Technique for the (b)(4) at the Canton Compounding Facility. However, the adequacy of this corrective action cannot be fully evaluated until the modifications are fully implemented and supporting documentation, such as executed batch production records, are provided for assessment.c. We acknowledge your plan to conduct a new “Dynamic Airflow Qualification” study to address your firm's failure to perform adequate smoke studies under dynamic conditions representative of actual production. However, since you estimate the study will not be complete until March 31, 2026, we cannot evaluate the adequacy of your corrective action at this time. We remain concerned about your inability to verify adequate airflow patterns within the ISO 5 aseptic processing area.2. Regarding your failure to establish an adequate system for cleaning and disinfecting the room to produce aseptic conditions:We acknowledge your response regarding the brown, rust-like residue found on the wheelbases of the laminar flow hoods and tables in your ISO 7 areas. We note your plan to update procedures to enhance inspection and cleaning of these surfaces as necessary. However, your response did not include evidence—such as photographs or other documentation—demonstrating that remedial actions (e.g., cleaning) have been completed. Without this documentation, we are unable to evaluate the adequacy of your corrective action at this time.3. Regarding your failure to maintain buildings used in the manufacture, processing, packing, or holding of drug products in a good state of repair, including paint chipping on air returns and a door, and a divot in the floor, all in ISO 7 areas:We acknowledge your plans to repair and refinish the affected air returns and doors, as well as to repair the floor. However, you failed to provide evidence, such as photos or executed work orders, demonstrating that the repairs have been completed. Consequently, we cannot evaluate the adequacy of your corrective action at this time.Some of your corrective actions appear deficient:1. Regarding your Quality Unit’s failure to exercise its responsibility to ensure drug products produced are in compliance with CGMP, and meet established specifications for identity, strength, quality and purity:We acknowledge the actions your firm has planned in response to its failure to adequately manage an adverse trend involving defects associated with your intravenous fluid bags. We note the following action items:Assess Fresenius Kabi vendor status based on review of defects noted.Target completion due date: 31Jan2025 [sic; date assumed to be 31Jan2026]Assess supplier qualification process regarding managing vendor complaints and escalations.Target completion due date: 31Jan2025 [sic; date assumed to be 31Jan2026]Update supplier qualification SOP based on closure of assessment.Target completion due date: 31Jan2025[sic; date assumed to be 31Jan2026]However, your response fails to address fundamental deficiencies in how your Quality Unit managed a significant adverse trend related to the container-closure system of your sterile drug products. For example, although the IV bag manufacturer/supplier acknowledged defects in the IV bags’ injection and infusion ports, they never communicated a definitive root cause. Without this root cause determination, you could not verify whether the manufacturer/supplier's corrective actions (e.g., equipment “maintenance”) adequately resolved the issue. Your firm continued to rely solely on visual inspection processes as the primary control mechanism to prevent defective units from reaching patients.Furthermore, requiring personnel to focus primarily on detecting port defects during visual inspection of finished sterile drug products raises concerns, as this may compromise their ability to identify particulates and other defects unrelated to ports.2. Regarding your failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed:We acknowledge the actions your firm has planned in response to its failure to adequately investigate and respond to an adverse trend involving defects associated with your intravenous fluid bags. We note the following action items:Assess bag storage and shipping configuration to determine if current storage & configuration has potential compressive stress on the seam of the (b)(4) IV Bag units.Target completion due date: 06Jan2026Assess the need for updates to the incoming inspection requirements of (b)(4) IV Bags.Target completion due date: 06Jan2026Update the customer complaint investigation process in FSSBOS-SOP-0041 to require that for “leaking unit” complaints, photos of the defective unit(s) are requested, and the units be returned to the facility for inspection.Target completion due date: 06Jan2026However, although you identified a trend involving defects with the (b)(4) infusion port seal across multiple supplier lots of various (b)(4) IV Bag configurations, you failed to take meaningful action such as pausing production or distribution. Instead, you opened an “Issue” to document and trend the events. You did not conduct a comprehensive risk analysis and never identified a definitive root cause. Despite failing to determine a definitive root cause through communication with the IV bag supplier ((b)(4)) for the observed defects—including (b)(4) port seals with (b)(4) “stress” marks, loose (b)(4) port seals, and partially seated (b)(4) port seals—you continued using these IV bags in production. You relied solely on visual inspection to identify and segregate defective units. This practice is inconsistent with good manufacturing practices, which require a drug process to remain in a state of control throughout its lifecycle. Knowingly using potentially defective container-closures in the production of a sterile drug product places the product at risk of contamination and puts patients at risk.3. Regarding your failure to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile:a. We acknowledge your response to the failure to ensure that operators’ behavior in the ISO 5 aseptic processing area does not block or otherwise compromise “first-air” to critical surfaces such as vials. We note your contention that vial reconstitution is not an aseptic practice, as well as your plans to reclassify this as such. However, sterile drug vial reconstitution is an aseptic process that must be performed in an ISO 5 area because it involves exposing a sterile product to the environment during manipulation. When reconstituting a sterile drug, the vial's closure system is breached to introduce a diluent, creating opportunities for microbial contamination. An ISO 5 environment provides the highest level of air cleanliness in the immediate work area, with stringent limits on airborne particulates that could carry microorganisms. This controlled environment, combined with proper aseptic technique, is essential to maintain product sterility and prevent contamination that could lead to serious patient harm. Additionally, while subsequent sterile (b)(4) of the bulk drug solution may provide a layer of protection, it does not eliminate the requirement to maintain aseptic conditions throughout the sterile drug production process.We further acknowledge your claim that vigorous shaking of the [vancomycin] vials is necessary to ensure complete dissolution of the drug in the diluent, as well as your intent to improve this process by requiring the hood to “(b)(4)” following reconstitution and prior to resumption of aseptic activities. However, this strategy fails to address the primary risk. As previously stated, rapid movement (i.e., vigorous shaking of vials) creates significant air turbulence that disrupts laminar airflow and increases contamination risk. A (b)(4) alone without supporting scientific evidence is not an effective contamination control strategy.b. We acknowledge your response regarding the failure to conduct all aseptic operations, including reconstitution of sterile vials and pooling of the resultant bulk drug solution, in a properly qualified ISO 5 environment. As previously stated, reconstituting sterile drug product vials and pooling them outside an ISO 5 environment creates a direct contamination risk. When performed outside an ISO 5 space, the process is no longer considered a sterile-to-sterile aseptic process. While we acknowledge the information you provided regarding sterilizing (b)(4) qualification (including compatibility and capacity) and additional controls such as full gowning, environmental monitoring within the ISO 7 mixing room, and sanitization of pooling bags, these measures do not replace the comprehensive validation process, including process simulation studies, necessary to validate such a process.4. Regarding your failure to establish an adequate system for monitoring environmental conditions in aseptic processing areas:We acknowledge your response regarding the failure to adequately perform active and passive air sampling within the ISO 5 area during aseptic operations, including your plan to initiate active air monitoring during filling operations. We recognize the importance of conducting effective environmental monitoring while minimizing the risk of contamination. However, your response fails to fully address the scope of the violation. Although conducting viable air sampling during filling represents an improvement, it does not address other critical steps in the aseptic operation where contamination risk is high and viable air monitoring may be necessary. Additionally, your response does not specify the duration of the production process or explain whether the frequency of viable air sampling adequately represents the processing environment throughout the entire production cycle. Furthermore, your response indicates that settle plate placement is described in FSSBOS-SOP-0013, “Cleaning Procedure for Classified Areas at the Canton Compounding Facility.” However, our review of this SOP indicates that it applies only to ISO-7, ISO-8, and ISO-9 areas. Consequently, the location of settle plates, used for passive air monitoring of the ISO 5 (b)(4) during aseptic operations, cannot be determined.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)].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.D. 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 (# 724551) 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:Deborah E. McHugh, Vice President of Quality for North AmericaFresenius Kabi Compounding, LLC20 Dan RdCanton, MA, 02021-2809___________________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.

为了进一步规范特殊食品注册申报，做好受理审评工作，现将有关要求公告如下：一、注册申请人现场提交行政许可项目申报材料、领取许可决定文书或配合开展特殊食品注册现场核查工作时，具体办理人员应当为注册申请人正式在职员工（现行法律法规有其他要求的情形除外），须同时提交注册申请人（与申请表盖章单位一致）向具体办理人员出具的授权委托书，以及具体办理人员的身份证明原件及复印件（原件核对后退回）。授权委托书参考式样详见附件1、附件2、附件3。二、注册申请人在注册、备案系统注册账号或者申报具体产品时，在注册系统和申请表中填写的联系方式应为注册申请人正式在职员工的联系方式（现行法律法规有其他要求的情形除外）。三、对于保健食品注册申请的联系人或联系方式等信息发生改变的，申请人可通过现场或邮寄的方式，及时向我中心受理大厅提交《保健食品联系方式变更申请书》。我中心将根据注册申请人提供的信息对保健食品注册审评系统中具体产品的联系人、联系方式等信息进行更新。对于信息更新不及时影响注册审评及注册现场核查工作开展的，由申请人承担相应责任。四、注册申请人应对提交的上述材料的真实性负责。经审核发现不属实的，将按《中华人民共和国行政许可法》中“隐瞒有关情况”或者“提供虚假材料”的情形处理。本公告内容自2026年6月9日起执行。特此公告。附件:1.授权委托书—办理行政许可事项受理业务用2.授权委托书—办理行政许可决定文书领取业务用3.授权委托书—办理特殊食品注册现场核查业务用国家市场监督管理总局食品审评中心2026年6月9日

为有效防控新业态下的用药安全风险，慈溪市局以“严查禁售红线、细化合规指引、深化普法宣贯”的工作思路，持续开展药品经营主体专项排查，夯实监管基础，织密药品网络销售风险防控网，切实守护群众用药安全。一是明确排查主体，紧盯“红线”抓整治。通过药品智慧监管一体化平台导出药品网络销售企业清单，聚焦热点平台，开展实时网络监测，着重核查线上销售网络禁售药品（重点关注普瑞巴林口服单方制剂、愈美制剂、《药品网络销售禁止清单（第一版）》）、O2O处方药订单未按照规定进行电子处方审核调配和使用后标记等，此外对投诉举报中涉及可能通过私域模式规避监管等隐蔽性违法线索进行摸排关注。二是聚焦过程监管，对标《指南》抓规范。根据《处方药网络零售合规指南》，指导网络销售企业建立并实施在线药学服务制度，并加强对网络销售运营人员的管理，定期开展网络销售和药品管理相关法律、法规和专业知识培训。要求企业严格落实风险提示义务，向消费者充分告知相关用药风险，并经消费者确认知情等，规范好药品网络销售行为。同时严查处方来源真实性，确保每笔处方药销售“有方可依、有据可查”。截至目前，共指导药品网络销售企业55家，发放《处方药网络零售合规指南》60余份。三是夯实法治基础，线上线下抓宣贯。积极开展普法宣传，把脉监管对象经营风险，深入浅出宣贯新修订的《中华人民共和国药品管理法实施条例》关注点，特别是明确禁止网络销售品种范围的条款和相应处罚条款，向药品经营企业讲明“三个什么”——“什么能做、什么不能做、做了有什么后果”，并通过现行相关法律法规要求交叉比对、典型案例“现身说法”等形式，强化监管对象风险防控意识、主体责任意识。线上通过全市药店微信群、QQ群做好最新法规、政策宣贯，合计普法1304人次。

国家医保局组织编写的《国家医保基金智能监管知识库、规则库（2025年版）》已于近日出版发行，以帮助定点医药机构及其工作人员熟悉掌握医保基金监管规则，通过智能化方式主动合规、持续合规，实现监管关口前移。现按计划将“药品限适应症”规则有关心血管系统药物对应知识点明细面向社会公开。各省级医保部门要及时根据最新知识点明细及代码对省级医保信息平台智能监管子系统“两库”进行动态更新。定点医药机构可以将智能监管“两库”置于本机构智能提醒等信息化系统中，也可以对接医保部门智能监管系统事前提醒功能模块，对医保基金使用行为开展自动提醒和自查自纠，将不合规的行为消除在“萌芽”阶段，从源头上减少使用医保基金违法违规行为发生。各级医保部门和定点医药机构在使用“两库”规则和知识点过程中的意见建议，欢迎及时向我们反馈。联系人邮箱：jjjgs522@nhsa.gov.cn。

各市、县、自治县人民政府，各有关单位：《海南省“十五五”高新技术产业发展规划》已经省政府同意，现印发给你们，请认真贯彻执行。海南省人民政府办公厅2026年6月5日（此文有删减）

各市、县、自治县市场监督管理局（药品监督管理局）、乐城医疗药品监督管理局，省局相关处室单位，各相关医疗器械经营企业：为深入贯彻《医疗器械监督管理条例》《医疗器械网络销售监督管理办法》《医疗器械网络销售质量管理规范》及国家药监局关于医疗器械网络销售监管有关工作要求，强化医疗器械网络交易第三方平台、医疗器械网络销售企业等依法落实质量安全主体责任，进一步加强我省医疗器械网络销售监督管理工作，结合我省实际，省药监局研究起草了《关于进一步加强医疗器械网络销售监督管理工作的若干措施（征求意见稿）》（附件 1），现公开征求意见。如有修改意见建议，请填写《意见建议反馈表》（附件 2），于 2026 年 6 月 19日前通过电子邮件反馈。联系人：康老师，电话：0898-66832661，邮箱：13876764161@163.com。附件：1.海南省药品监督管理局关于进一步加强医疗器械网络销售监督管理工作       的若干措施（征求意见稿）      2.意见建议反馈表                                  海南省药品监督管理局                                     2026 年 6 月 9 日（此件主动公开） 附件：海南省药品监督管理局关于进一步加强医疗器械网络销售监督管理工作的若干措施（征求意见稿）为深入贯彻《医疗器械监督管理条例》《医疗器械网络销售监督管理办法》《医疗器械网络销售质量管理规范》及国家药监局关于医疗器械网络销售相关部署要求，督促医疗器械网络交易第三方平台、医疗器械网络销售企业及相关经营者依法落实质量安全主体责任，现就进一步加强我省医疗器械网络销售监督管理工作，制定以下措施。一、严控平台入口，全面落实主体责任（一）严把平台备案与入驻资质审核关。在海南省行政区域内提供医疗器械网络交易第三方平台（以下简称平台）服务的经营者，应依法向海南省药品监督管理备案。平台应当建立严格的入驻审查制度，对申请入驻的医疗器械网络销售企业资质进行实质性核对，确保其具备合法有效的医疗器械经营许可证/备案凭证，严禁资质造假、挂靠借用或超范围入驻。平台对入驻企业建立登记档案，每半年至少核验更新1次，确保符合法定要求。（二）规范平台内经营者资质信息动态公示。平台应当确保入驻的医疗器械经营者在网站首页或经营活动主页面显著位置，持续公示医疗器械经营许可证、备案凭证、营业执照等资质信息。鼓励平台设立资质信息预警功能，及时提醒经营者更新相关信息，发现资质信息变更、注销或过期的，平台应立即采取限制、暂停服务等措施，确保经营行为和资质信息公示符合规定要求。（三）健全平台质量安全管理机构与人员配置。平台应依法设置医疗器械质量安全管理机构，配备与其业务规模相适应的质量管理人员与医学相关专业人员，负责医疗器械网络销售质量管理、日常巡查、不良事件收集上报等工作。严禁平台在缺乏质量管理体系和技术支撑情况下开展医疗器械网售服务。（四）压实平台日常巡查与质量安全风险监测职责。平台应建立并执行覆盖全部入驻经营者的常态化巡查制度，重点核查无证经营、超范围经营、销售未经注册/备案产品、假冒伪劣产品等行为，及时发现并处置质量安全隐患。运用信息化手段对医疗器械展示、销售、配送等行为动态监测，督促入驻企业落实全链条追溯管理。（五）强化落实违法违规行为制止与报告制度。平台应履行对入驻经营者违法行为的制止、报告与停止服务义务，严禁对违法违规行为默许、放任或包庇。平台在巡查或投诉举报中发现入驻企业存在无证经营、超范围经营、销售禁售/未经注册/备案产品等严重违法行为的，应立即采取下架商品、限制功能、停止平台服务等制止措施，并保存证据记录，第一时间向所在地药品监管部门报告。二、规范销售行为，严守网售合规底线（六）严格执行分类管理与风险信息公示。平台及经营者应完善系统功能，对第一类、第二类、第三类医疗器械分区分类展示。在产品页面显著位置标注注册证号/备案号、适用范围、禁忌、警示提示等信息，确保信息真实、准确、可追溯，不得虚假、夸大、误导性宣传。（七）坚守特殊管理及禁售网络销售红线。平台应建立禁售清单和审核拦截机制，不得将植入介入类等高风险医疗器械网络销售给个人，严禁销售未依法注册、无合格证明文件、过期、失效、淘汰的医疗器械。系统预警或人工发现后立即采取阻断、下架、停止平台服务等制止措施，并保存证据记录，第一时间向所在地药品监管部门报告。（八）强化网络销售医疗器械配送环节质量管理。网络销售经营者应严格落实医疗器械配送质量管理规范，根据产品剂型、包装、储运条件、温湿度要求选择具备相应能力的配送企业。对冷链、无菌、植入等高风险产品，确保全程温控、独立包装、明显标识、全程可追溯，保障“最后一公里”质量安全。（九）规范网络交易数据记录与留存管理。平台及经营者对需要核实购买者身份信息的医疗器械，应当通过技术手段进行核验。平台应完整记录并保存资质审核、交易信息、追溯码、配送轨迹、售后服务、不良事件等信息，相关记录保存期限不少于5年，且不少于医疗器械有效期满后2年，确保全过程真实、完整、可追溯，依法配合监管部门数据调取与核查。三、强化重点领域整治，打击违法违规行为（十）厘清医疗器械网络直播营销行为合规边界。平台及经营者应严格规范网络直播营销，严厉打击非医疗器械经营企业在直播中以任何形式违规推介、宣称疗效、误导购买等行为。严禁医疗器械经营企业在直播中直接展示无证产品，以及变相引导违规购买、夸大适用范围。（十一）全面排查整治社交电商等私域流量违规售械。加强对微信小程序、企业微信、社交群组、短视频等私域场景的监测排查，严厉打击未取得资质的企业违规售械、非法渠道购进、无证分销等行为，依法查处违规为提供发布渠道或技术支持的第三（十二）严厉打击网络销售医疗器械虚假宣传及违法广告。严格规范网络销售医疗器械信息发布，非医疗器械严禁宣传治疗、诊断功能，或作医疗器械宣传；医疗器械广告须经依法审查方可发布，严格按照规定规范广告宣传。联合市场监管部门严厉打击详情页、直播话术、短视频中的虚假、误导等违法违规行为。四、强化创新监管机制，提升监管效能（十三）建立监测与处置联动闭环机制。依托国家医疗器械网络销售监测平台、第三方专业机构强化网络销售风险隐患监测，开展大数据筛查、智能预警、固证取证。对违规线索实行“线上固证—线索交办—线下核查处置—结果反馈”的闭环管理，提升精准打击与风险处置效能。（十四）严打违法违规网售医疗器械行为。将医疗器械网络销售风险排查整治作为经营环节清查治理重要内容，严肃查处销售无证、假冒、过期产品、非法渠道购械、违规销售高风险产品、虚假宣传等典型案件，依法公开曝光，形成震慑，净化网络医疗器械市场秩序。五、强化执法联合惩戒，构建协同共治格局（十五）实施违法失信联合惩戒。建立平台及网售经营者信用档案。对屡次违规、拒不整改、抗拒检查或造成严重不良影响的平台及网店，依法依规列入严重违法失信名单，实施跨部门联合惩戒，强化信用约束。（十六）强化部门间协同监管与行刑衔接。加强与市场监管、网信、公安及跨区域药监部门等协同联动，对重大跨区域、跨平台的违法案件，进行联合挂牌督办；对平台放任违法销售以及经营者非法经营、销售不合规医疗器械等违法行为，坚决移送公安机关追究刑事责任。（十七）畅通社会共治与科普宣传。完善网络销售投诉举报处置机制，畅通投诉举报渠道，鼓励内部员工和广大群众举报违法违规行为。强化舆情监测预警，及时回应社会关切。加强安全用械科普宣传，引导公众理性选购、正规渠道购买、规范使用，防范用械安全风险。本措施自印发之日起施行，国家药监局对医疗器械网络销售如有新规定的，从其规定。

　　为贯彻落实《医疗器械监督管理条例》《医疗器械生产监督管理办法》《医疗器械生产质量管理规范》，规范和指导医疗器械生产检查工作，国家药监局组织起草《医疗器械生产质量管理规范检查指导原则（征求意见稿）》（见附件1），现向社会公开征求意见。　　公开征求意见时间为2026年6月9日—6月24日。有关单位和个人请将意见建议反馈表（见附件2）发送至邮箱：mdgmp@cfdi.org.cn，并在电子邮件注明“医疗器械生产质量管理规范检查指导原则反馈意见”。　　　　附件：1.医疗器械生产质量管理规范检查指导原则（征求意见稿）　　 2.意见建议反馈表模板　　　　国家药监局综合司2026年6月9日