沪药监械主召2025-215瑞速（上海）医疗器械有限责任公司报告，由于涉及产品因特定的感兴趣区域（ROI）在极少数情况下，计算剂量的失效机制可能无法按预期工作。此问题仅出现在未定义轮廓线但具有主图像轮廓形状的ROI上，ROI同时需满足以下任一条件：定义了材料覆盖，或属于填充物、固定装置或支撑物。在此类情况中，向该ROI添加几何结构、后续修改几何结构或移除材料覆盖，均无法按预期使剂量失效。等问题，瑞速（上海）医疗器械有限责任公司对其生产的放射治疗计划软件（注册证号：国械注进20193210441）主动召回。召回级别为三级。涉及产品的型号、规格及批次等详细信息见《医疗器械召回事件报告表》。附件：医疗器械召回事件报告表(点击下载)2025年12月03日

Delivery Method:Via Electronic Mail - Delivery and Read Receipt RequestedProduct:DrugsRecipient:Laura MartinCEOTurbare Manufacturing925 Jeanette DriveConway,AR72032-6651United StatesIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERWL # 713516September 16, 2025Dear Ms. Martin: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]1on June 23, 2023, and most recently on January 25, 2025. From January 14, 2025, to January 24, 2025, an FDA investigator inspected your facility, Turbare Manufacturing, located at 925 Jeanette Drive, Conway, Arkansas 72032. During the inspection, the investigator noted serious deficiencies in your practices for producing drug products intended or expected to be sterile, which put patients at risk.FDA issued a Form FDA 483 to your facility on January 24, 2025. We reviewed your February 14, 2025, and April 30, 2025, response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence. FDA also acknowledges that, on February 18, 2025, your firm initiated a voluntary recall of Bevacizumab 1.25mg/0.05mL in 0.25mL Syringe, Lot # 12192024(b)(4)and Lot # 12122024(b)(4), 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.An 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 investigator noted that drug products intended or expected to be sterile were prepared, packed, or held under insanitary conditions, whereby they may have become contaminated with filth or rendered injurious to health, causing your drug products to be adulterated under section 501(a)(2)(A) of the FDCA. For example, the investigator observed that:1. Your firm failed to conduct process simulation (media fill) studies that closely simulate aseptic production operations under the worst-case, most challenging, and stressful conditions.The FDA investigator also noted CGMP violations at your facility, that caused your drug products to be adulterated within the meaning of section 501(a)(2)(B) of the FDCA. The violations include, for example:1. Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192).2. Your firm failed to establish acceptance criteria for the sampling and testing conducted by the quality control unit that are adequate to assure that batches of drug products meet appropriate statistical quality control criteria as a condition for their approval and release (21 CFR 211.165(d)).3. Your firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic processes (21 CFR 211.113(b)).4. Your firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas (21 CFR 211.42(c)(10)(iv)).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. We also acknowledge your voluntary recall of Bevacizumab 1.25mg/0.05mL in 0.25mL Syringe, Lot # 12192024(b)(4)and Lot # 12122024(b)(4), due to lack of sterility assurance.Some of your corrective actions appear deficient:1. Regarding your firm’s failure to thoroughly investigate any unexplained discrepancy, or the failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed:a. We acknowledge the actions taken by your firm in response to your failure to investigate the recovery of 1 cfu mold (i.e.,Curvularia intermedia) from an operator’s(b)(4)sample during personnel monitoring, performed in association with (aseptic processing) media fill lot # 11252024(b)(4), including Investigation Record # NCR-25-002 and Document Change Request # DCR-071, as well as updates to/implementation of the following documents: SOP-048 (Routine Environmental Monitoring), TEM-034 (EM Investigation Template), and SOP-088 (Reading of Microbiological Culture Media). However, while your investigation attempts to identify the source and impact of the contamination, you failed to determine why the excursion itself was not investigated at the time of occurrence. Consequently, there is no assurance of your ability to initiate investigations in a timely manner. Furthermore, your investigation concludes the likely root cause of the excursion was “ineffective cleaning, due to stressing the environment for Media Fill…” While process simulation (i.e., media-fill) studies should be conducted under “worst-case” scenarios (e.g., simulating largest batch size, longest processing time, and routine & non-routine interventions), they should also be conducted in accordance with all related approved procedures (e.g., cleaning procedures).Consequently, the intentional lack of cleaning may confound the results of the media fill study. Your response suggests your process simulation procedures should be reassessed and modified, as necessary.b. We acknowledge actions taken by your firm in response to your failure to investigate the recovery of 1 cfu from an operator’s(b)(4)fingertip sample, performed in association with the production of Bevacizumab 1.25mg/0.05mL in 0.25mL syringes, Lot # 11132024(b)(4)in BSC 0003, including the closure of DCR-071, updates to SOP-048, and the implementation of TEM-034, etc. However, we note that while section 6.10.1 of SOP-048 (Routine Environmental Monitoring) reads in part “…investigations are targeted for closure within(b)(4)from initiation,” it does not appear to specify a time frame within which such investigations must be initiated. Consequently, there’s no procedural safeguard to prevent delays in initiating investigations into environmental monitoring excursions.c. We acknowledge actions taken by your firm in response to your failure to identify and investigate the failure of two batches of drug product (i.e., Bevacizumab, Lot # 12122024(b)(4)and Lot # 12192024(b)(4)) to comply with appropriate Acceptable Quality Limits (AQL) for visible particulates. We acknowledged the voluntary recall of the two aforementioned lots of drug product, as well as revisions to SOP-075 (Acceptable Quality Limit (AQL)), which align with the generally acceptable standards established in(b)(4). However, we remain concerned with conclusions derived from Incident ID # INC-25-002, specifically your contention the batches in question were acceptable based on an examination of an additional(b)(4)units from retain samples of each of the lots. For example, per document number FRM-071 (Version 02, 12 DEC2024), your “AQL” at the time the batches were produced was(b)(4)%. Your defect rates for those categorized as “Major” were erroneously calculated as 0.3% and 0.1% for Lot # 12192024(b)(4)and Lot # 12122024(b)(4), respectively. However, the rate should be calculated based on the actual sample size (i.e.,(b)(4)units), which results in a 13.3% and 6.7% “Major” defect rate for Lot # 12192024(b)(4)and Lot # 12122024(b)(4), respectively, which should have triggered a non-conformance investigation. Your retrospective investigation fails to address this deficiency.2. Regarding your firm’s failure to establish acceptance criteria for the sampling and testing conducted by the quality control unit that are adequate to assure that batches of drug products meet appropriate statistical quality control criteria as a condition for their approval and release:a. We acknowledge actions taken by your firm in response to your failure to establish statistically valid sampling plans as part of your visual inspection program. Specifically, we acknowledge updates to SOP-075 (Acceptable Quality Limit (AQL)), including the implementation of AQL sampling plans consistent with generally accepted standards for acceptance sampling by attribute (e.g.,(b)(4)) for your visual inspection processes. We also note you established process flow charts to guide the decision matrix when either the 100% visual inspection or an AQL inspection fail. According to your process (i.e., per SOP-075), the failure of the initial 100% visual inspection for critical defects triggers a non-conformance investigation. However, you failed to provide a rationale for allowing a second 100% visual inspection, without an investigation in cases where the initial 100% visual inspection fails for minor and/or major defects.3. 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 firm’s actions, taken in response to your failure to conduct media fills that closely simulate aseptic production operations under the worst-case, most challenging, and stressful conditions, pursuant to an approved written study protocol. We recognize the distinction between aseptic personnel qualification procedures and aseptic process simulation (i.e., media fills). Our review of the document titledSummary Report for Syringe Repackaging Media Fill – 0.25 ml(b)(4)indicates a single batch (Lot # 01312025(b)(4)) was produced on 01/31/2025 yielding a total of(b)(4)units (i.e., syringes). The summary report and associated batch records indicate that 25 “Major” defects were identified during the initial 100% visual inspection process, all for “fill volume” defects. This equates to a(b)(4)% Major defect rate, under the(b)(4)% Defect Alert Limit established by SOP-061100% Visual Inspection of Injectable Product. The report further indicates “…no variances observed during the execution of the MFP-025-001.” Review of the batch records associated with the media fill indicate that routine and non-routine interventions (e.g., goggle adjustment, spill clean-up, simulated break/shift-change; as well as excessive filling time, batch size, and vial punctures), were employed. However, it is also observed that in accordance with SOP-074, you omitted routine cleaning of the ISO(b)(4)room and ISO(b)(4)hood prior to production. While it is important to simulate the aseptic process under worst-case, most stressful conditions, it is not appropriate to omit routine pre-production cleaning as this may skew the results. For example, if a microbial excursion is encountered, either in environmental monitoring results or sterility testing results, the root cause may be falsely attributed to the lack of routine, pre-production cleaning, instead of a potential breach in, for example, aseptic technique (e.g., failure to disinfect gloved hands), etc. Furthermore, it is noted this was considered a “requalification” activity. As such, only one full-scale batch was produced. However, since the media fill batches, produced in May 2024, were not considered adequate due to the failure to include routine/non-routine interventions, this protocol should have been treated as an initial media-fill qualification activity consisting of three successful, consecutive full-scale batches.4. Regarding your firm’s failure to establish an adequate system for monitoring environmental conditions in aseptic processing areas:a. We acknowledge your firm’s actions, taken in response to your failure to implement written procedures which adequately describe the process for investigating environmental monitoring excursions. We recognize enhancements made to SOP-048 (Environmental Monitoring Program), including section 6.10.1 which describes the processes for conducting EM Investigations. It is noted the procedure requires an evaluation of related documents, including cleaning records, equipment records, batch production records, operator qualification, etc. The procedure also requires that a root cause analysis and impact assessment be performed, concluding with a recommendation regarding batch disposition, where applicable. We further note the procedure reads, in part “…actionable environmental or personnel monitoring recoveries require a documented investigation into the potential root cause and subsequent impact… investigations are targeted for closure within(b)(4)from initiation.” However, as noted in item 1(b), above, it does not appear to specify a time frame within which such investigations must be initiated. Consequently, there is no procedural safeguard to prevent delays in initiating investigations into environmental and personnel monitoring excursions.Furthermore, according to section 6.4 of SOP-048, active viable air monitoring of the ISO(b)(4)area is conducted “At least(b)(4)per Production Batch.” However, review of the media fill batch production records for Lot # 01312025(b)(4)indicates it can take over(b)(4)to complete the syringe repackaging process alone. Consequently, your active air sampling process does not adequately reflect environmental conditions throughout the aseptic production process.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 (# 713516) 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/F. Gail Bormel, JD, RPhDirectorOffice of Compounding Quality and ComplianceOffice of ComplianceCenter for Drug Evaluation and Research_________________________1See Pub. L. No. 113-54, § 102(a), 127 Stat. 587, 587-588 (2013).

按照《药品经营和使用质量监督管理办法》第二十七条规定，根据企业申请，现注销山西世纪宏业医药股份有限公司药品经营许可证（许可证号：晋AB 351000005）、山西蓝阳医药科技有限公司药品经营许可证（许可证号：晋AA 351000190）。特此通告。山西省药品监督管理局2025年12月1日 （主动公开）

按照《化妆品生产经营监督管理办法》（国家市场监督管理总局令第46号）等相关规定，现将2025年十一月湖北省化妆品生产许可相关信息予以公告，详见附件，请社会各界予以监督。监督电话：027-8711152312315通讯地址：湖北省武汉市武昌区公正路19号101室邮编：430071附件：湖北省2025年十一月化妆品生产企业许可表。

沪药监械主召2025-214迈柯唯（上海）医疗设备有限公司报告，生产企业经调查发现手术台系统光学接触模块中的新型 LED 可能在床柱和床板之间产生干扰信号（更宽的光束角度）。可能导致在某些操作的情况中出现，床板朝相反趋势方向移动的情况以及床板无法归零的情况。本着对客户负责的态度，确保设备使用安全、有效，企业决定对其进行召回。迈柯唯（上海）医疗设备有限公司对其生产的手术台系统 OPERATING TABLE SYSTEM（注册证号：国械注进20152151263）主动召回。召回级别为二级。涉及产品的型号、规格及批次等详细信息见《医疗器械召回事件报告表》。附件：医疗器械召回事件报告表(点击下载)2025年12月02日

各市（含定州、辛集市）市场监督管理局、农业农村局、工业和信息化局、卫生健康委，雄安新区综合执法局、农业农村局、工信科技数据局、卫生健康局：为进一步规范我省中药材产地趁鲜切制加工工作，加强中药质量源头管控，促进中医药产业高质量发展，省药品监督管理局、省农业农村厅、省工业和信息化厅、省中医药管理局组织研究制定了《河北省中药材产地趁鲜切制加工品种目录（第二批）》，包括白头翁等35个中药材品种，现予以公布。附件：《河北省中药材产地趁鲜切制加工品种目录（第二批）》河北省药品监督管理局河北省农业农村厅河北省工业和信息化厅河北省中医药管理局2025年11月28日（信息公开类型：主动公开）

根据《化妆品注册备案管理办法》和《国家药监局关于实施，备案人应当于每年1月1日至3月31日期间，通过化妆品注册备案信息服务平台提交备案时间满一年的普通化妆品年度报告。我省相关企业未履行普通化妆品年度报告法定义务，且未按要求在规定期限内改正，现依据《化妆品注册备案管理办法》第三十七条第一款、第五十九条第二项规定，拟依法取消相关普通化妆品备案（产品清单见附件1）。相关产品备案人对被取消备案产品有异议的，请在本公告发布后30日内，携带有效市场主体登记证明（《营业执照》等）、法定代表人或主要负责人身份证（如非法定代表人或主要负责人，应提供委托书及受托人身份证）及《化妆品取消备案陈述、申辩书》（附件2），向所在地市级药品监督管理部门（联系方式见附件3）提出陈述、申辩；逾期未提出的，视为放弃陈述、申辩的权利。逾期未提出陈述、申辩或经审核陈述、申辩意见未被采纳的，将对相关普通化妆品取消备案。附件：1.拟取消未提交年度报告普通化妆品备案产品清单.pdf 2.化妆品取消备案陈述、申辩书.pdf 3.各设区市市场监管局联系方式.pdf江苏省药品监督管理局 2025年11月10日

贵州省药品监督管理局行政处罚案件信息公开表（第一百五十一期）序号行政处罚决定书文号案件名称违法企业名称或违法企业自然人姓名违法企业组织机构代码法定代表人姓名主要违法事实行政处罚的种类和依据作出处罚的机关名称和日期备注1黔药监行罚〔2025〕50号贵阳道生健康产业有限公司生产劣药野菊花案贵阳道生健康产业有限公司统一社会信用代码：91520123MA6DLKPF0W夏德勇生产劣药野菊花处罚种类：1.没收非法财物；2.没收违法所得；3.罚款。处罚依据：《中华人民共和国药品管理法》第一百一十七条第一款贵州省药品监督管理局2025年11月21日2黔药监行罚〔2025〕51号贵州九立德生物制药有限公司未按照化妆品备案资料载明的技术要求生产化妆品案贵州九立德生物制药有限公司统一社会信用代码：91520115322262118E程丹涛未按照化妆品备案资料载明的技术要求生产化妆品处罚种类：没收非法财物。处罚依据：《化妆品监督管理条例》第六十条第二项贵州省药品监督管理局2025年11月28日

江西中维医药有限公司因企业自身原因，向我局报告暂停药品经营活动。自公告之日起，江西中维医药有限公司停止开展药品经营活动。如需恢复药品经营，应向我局提出申请，经现场检查符合《药品经营和使用质量监督管理办法》规定后方可恢复。附件：暂停药品经营企业名单江西省药品监督管理局2025年12月2日附件暂停药品经营企业名单序号企业名称药品经营许可证号法人经营地址1江西中维医药有限公司赣AA796000853罗时来江西省吉安市吉水县城西工业园区田溪路6号综合楼三楼301-305室

　　按照《医疗器械监督管理条例》规定，根据企业申请，国家药品监督管理局现注销以下4家企业共9个产品的医疗器械注册证：　　一、韩国露晰得株式会社的1个产品：硬性角膜接触镜，注册证编号：国械注进20163161459。　　二、深圳市致恒电气新技术有限公司的1个产品：电磁式体外冲击波碎石机，注册证编号：国械注准20173014554。　　三、施乐辉外科植入物（北京）有限公司的4个产品：陶瓷头，注册证编号：国械注准20183130225；不锈钢双极头，国械注准20183130488；人工髋关节，注册证编号：国械注准20153130604；压配式球形臼，注册证编号：国械注准20183131771。　　四、美国雅培公司 Abbott Laboratories的3个产品：血细胞分析仪用校准品CELL-DYN HemCal Plus Calibrator，注册证编号：国械注进20182401985；网织红细胞质控品CELL-DYN Retic Plus Control，注册证编号：国械注进20182401986；血细胞分析仪用质控品CELL-DYN 29 Plus Control（with Retic），注册证编号：国械注进20182401987。　　特此公告。　　　国家药监局2025年11月28日