根据《药品网络销售监督管理办法》（国家市场监督管理总局令第58号）规定，现对药品网络交易第三方平台备案信息予以公告。附件：湖北省药品网络交易第三方平台备案信息公告（2026年5月）湖北省药品监督管理局2026年6月1日  

根据《医疗器械网络销售监督管理办法》（2017年12月20日国家食品药品监督管理总局令第38号）的有关规定，现将湖北省2026年5月医疗器械网络交易第三方平台备案相关信息予以公告。湖北省药品监督管理局   2026年6月3日      附件：医疗器械网络交易第三方平台备案信息表 （2026年5月）

为深入开展树立和践行正确政绩观学习教育，落实“为民造福”要求，近日，省药监局第三检查分局组织药品流通企业开展集中销毁不合格药品活动，辖区28家企业参加此次活动。此次集中销毁是第三检查分局持续帮助企业解决实际困难的具体举措。辖区药品流通企业在自愿的前提下，将不合格药品统一收集到具备处置危废物品资质的专业技术单位进行集中销毁。活动过程中，第三检查分局要求相关药品流通企业必须认真履行主体责任，严格执行药品经营质量管理规范要求，做好不合格药品处置的相关手续和记录，防范处置不当造成的药品安全风险。参加活动的企业表示，集中销毁活动既解决了企业销毁不合格药品难、成本高的问题，更有效督促了企业及时防范药品安全风险。下一步，第三检查分局将积极联系驻地有关监管部门和专业的危废收集处理单位，探索形成集中销毁不合格药品的长效机制。（韩秉国）

根据《宁夏回族自治区药品经营企业长期停业和恢复经营监督管理规定》（宁药监规发〔2025〕2号）相关要求，北京第一生物科技集团（宁夏）医药有限公司向宁夏回族自治区药品监督管理局提交停业申请，企业承诺停业期间停止一切药品经营活动。企业在《药品经营许可证》有效期内恢复药品经营活动，需向宁夏回族自治区药品监督管理局提交书面报告，并经检查符合要求后方可恢复药品经营活动。现将企业信息予以通告。 附件：长期停业药品经营企业信息 宁夏回族自治区药品监督管理局2026年6月10日（此件公开发布） 附件长期停业药品经营企业信息企业名称药品经营许可证号许可证有效期至注册地址停业截止时间北京第一生物科技集团（宁夏）医药有限公司宁AA9510000982031年2月11日宁夏银川市兴庆区清河北街春满园14号楼10号营业房二楼、三楼2030年9月26日 

为切实保障群众夏季用药安全，防范高温高湿天气带来的药品质量风险，北仑区局紧盯季节特点，精准施策，全面加强零售药店药品安全监管，筑牢药品安全防线。一、聚焦夏季储存风险，严守药品质量“生命线”。针对夏季高温高湿气候特点，重点围绕零售药店药品储存条件开展集中整治。以线上线下联动方式，织密温湿度监控网络。通过线上“黑匣子”系统，对零售药店温湿度远程、不间断监测，同时加强线下“回头看”，对温湿度多次异常、拒不改正的零售药店开展重点巡查，严防因储存不当导致药品变质失效。截至6月4日，已对辖区79家温湿度监测异常的零售药店发出线上“提醒单”，督促其及时整改。二、规范药品经营行为，全面排查夏季用药隐患。北仑区局在加强储存条件监管的同时，统筹推进零售药店日常经营行为的规范化管理。重点核查药品购销存记录是否真实完整，是否存在非法渠道购药、超范围经营处方药、执业药师不在岗履职不到位、近效期药品管理混乱等问题。针对夏季高温环境下药品易变质等特点，加大对近效期药品的排查频次，严防变质药品流入市场。截至6月4日，完成83家零售药店巡查。三、拓宽宣传引导维度，构建社会共治格局。针对季节性储药特点，北仑区局积极利用药店电子屏、公众号等渠道，普及夏季家庭常备药（如益生菌、糖浆、软膏）的储存要点、识别药品变质（变色、异味、沉淀等）知识及合理用药常识。同时畅通“12315”等举报投诉渠道，鼓励公众参与监督，形成“专业监管+社会监督”合力。

各医疗机构:为严厉防范和打击“回流药”等违法违规行为，斩断非法利益链条，规范医疗机构药品采购与储存管理，坚决维护医疗保障基金安全，切实保障人民群众用药安全与合法权益，依据《中华人民共和国药品管理法》《中华人民共和国药品管理法实施条例》《药品经营和使用质量监督管理办法》等法律法规，现就医疗机构药品使用质量管理要求提示如下:一、严格合法渠道购进医疗机构应当从药品上市许可持有人或者具有药品生产、经营资格的企业购进药品，购进药品时，应当核实供货单位的药品生产或者经营许可证等资质证明文件、药品的批准证明文件等，并保存加盖其公章原印章的复印件。医疗机构购进药品时应当索取、留存合法票据，包括税票及详细清单，清单上应当载明供货单位名称、药品通用名称、药品上市许可持有人(中药饮片标明生产企业、产地)、批准文号、产品批号、剂型、规格、销售数量、销售价格等内容。二、规范进货检查验收与记录医疗机构购进药品，应当建立并执行进货检查验收制度，验明药品合格证明和其他标识;不符合规定要求的，不得购进和使用。购进药品必须有真实、完整的购进记录，记录应当注明药品的通用名称、药品上市许可持有人(中药饮片标明生产企业、产地)、批准文号、产品批号、剂型、规格、有效期、供货单位、购进数量、购进价格、购进日期。医疗机构应当建立要盖药品购进、储存、使用的全过程追溯体系，开展追溯数据校验和采集，按规定提供药品追溯信息。三、依法依规储存保管医疗机构应当有与所使用药品相适应的场所、设备、仓储设施和卫生环境。应当制定和执行药品保管制度，采取必要的冷藏、防冻、防潮、防虫、防鼠等措施，保证药品质量。应当根据药品包装标示的温度要求，在相应温度条件的场所存放药品，并采取避光、遮光、通风等措施,各医疗机构应切实履行药品使用质量安全的主体责任，严格对照上述法定要求开展自查自纠。对违法违规购进、储存药品的，药品监督管理部门将依法严肃查处;涉及套取医保基金的，将依法移送医保部门及公安机关严肃处理。

6月10日，黑龙江省林业和草原局组织制定的《林下刺五加复合种植技术规程》《林下山参复合生态栽培技术规程》《林下黄精复合种植技术规程》《林下赤芍复合种植技术规程》《林下龙牙楤木复合种植技术规程》《林下白鲜复合种植技术规程》《林下茖葱复合种植技术规程》等7项林下复合种植团体标准由省林学会正式发布。这一系列标准的落地实施，是黑龙江省积极响应国家林草局《关于促进林下经济发展的若干措施》的具体行动，率先打通国家二级公益林林下经济标准化发展路径，破解黑龙江省森林林下空间利用瓶颈，为全省林下特色种植产业高质量发展筑牢标准化根基、划定规范底线、指明前行方向。近年来，黑龙江省深入践行“绿水青山就是金山银山”理念与大食物观，依托广袤的森林资源，将林下经济作为林草产业转型升级、助力乡村振兴、推动生态产品价值实现的核心抓手。国家林草局相关政策明确提出，在坚守生态保护底线、不破坏森林生态功能的前提下，允许科学有序利用二级公益林、地方公益林发展林下经济，鼓励各地结合实际制定配套技术标准，实现森林资源空间复合利用与功能协同提升。此前，受技术规范缺失、经营模式模糊等因素制约，二级公益林林下资源开发始终面临“不敢用、不会用、乱利用”的困境，广阔的林下空间资源难以转化为产业优势与民生福祉。此次黑龙江省7项团体标准的出台，精准回应政策要求与产业痛点，实现生态保护与产业发展的双向统筹。此次发布的7项团体标准，聚焦林下山参、刺五加、黄精等七种龙江道地林药、林菜品种，结合本地气候与林地条件，贯穿种植全流程。标准区分商品林与公益林管理模式，针对二级公益林明确轻扰动整地、低密度栽植、生态化抚育等要求，坚持生态优先原则，既守护森林生态，又打通公益林合规利用技术壁垒。同时，整套标准搭建起黑龙江省林下复合特色种植标准化技术体系，针对传统散户经营模式粗放、产品品质不一、易破坏生态等问题，新规统一土壤、郁闭度、农药化肥使用等关键指标，细化各项实操流程，推广仿生态复合栽培模式。下一步，黑龙江省林业科学院将持续做好标准的宣传解读、技术推广与落地指导工作，组织技术人员深入林区、林场开展实操培训，引导经营主体严格按照标准规范生产，并持续完善林下经济标准体系，不断丰富标准品类，以标准化引领规范化、以规范化促进产业化，全力推动黑龙江省林下经济提质增效、行稳致远，真正把森林“四库”资源优势转化为生态优势、产业优势和民生优势，奋力书写新时代龙江林草高质量发展新篇章。

根据《贵州省医疗保障定点零售药店协议管理经办规程（试行）》（黔医保中心发〔2021〕26号）《贵州省医疗保障定点医疗机构协议管理经办规程（试行）》（黔医保中心发〔2021〕27号）要求，现将2025年第三批（第二轮）及2026年第二批拟新增为省本级医疗保障定点的12家医疗机构和2家零售药店名单予以公示。公示期间如对公示单位的相关资格有异议的，可通过来人、来电或来信等形式，直接向贵州省医疗保障事务中心反映，须提供真实姓名、工作单位和确切的联系方式，以便查结后回复，反映内容须实事求是，并提供反映问题的真实证据，受理部门将对反映信息予以严格保密。反映内容不实或隐瞒真实身份的，受理部门将不予受理。公示时间：7个工作日（2026年6月10日—2026年6月18日）受理部门电话：0851-85977752中心纪检部门电话：0851-85976461受理时间：工作日8:30-12:00,14:00-17:30附件-新增省本级基本医疗保障定点医药机构名单.xlsx序号医疗机构名称机构类型医药机构地址1息烽县养龙司镇中心卫生院医疗机构息烽县养龙司镇养龙司村龙腾路88号2贵阳市乌当区东风镇卫生院医疗机构贵阳市乌当区东风镇街上3修文县大石布依族乡卫生院医疗机构修文县大石布依族乡4修文县谷堡镇卫生院医疗机构修文县谷堡镇折溪村/乌栗村5贵阳市花溪区燕楼镇卫生院医疗机构贵阳市花溪区燕楼镇燕楼村6花溪区青岩镇卫生院医疗机构花溪区青岩镇交通路程252号7贵阳市花溪区久安乡卫生院医疗机构花溪区久安乡小山村8息烽县石硐镇卫生院医疗机构息烽县石硐镇石硐街和谐路210号9息烽县九庄镇中心卫生院医疗机构息烽县九庄镇兴隆路134号10贵阳观山湖一牙兔口腔门诊部医疗机构观山湖区世纪城街道金阳南路6号贵阳世纪城E组团购物中心三2层1号贵阳世纪金源购物中心C区三层童兜天地CF3S001A11南明新洲诊所医疗机构贵阳市南明区大理石路润丰家园4-5号楼负一层12号12云岩区黔灵镇社区第三卫生服务站医疗机构云岩区沙河村百花山二组29A13贵阳湘禾合朋大药房零售药店贵州省贵阳市花溪区石板镇合朋村三农创业发展有限公司二组团C区加一层商铺14清镇一树吾悦大药房（个人独资）零售药店贵州省贵阳市清镇市青龙山街道吾悦广场建设项目自14、20栋（20）1-5号贵州省医疗保障事务中心 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