Delivery Method:Via Electronic Mail - Delivery and Read Receipt RequestedReference #:320-25-113Product:DrugsRecipient:Ms. Treasure HolstonChief Executive OfficerKath Khemicals LLC51821 Industrial DriveMacomb,MI48042United StatesIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter320-25-113September 22, 2025Dear Ms. Holston:The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Kath Khemicals LLC, FEI 3000719870, at 51821 Industrial Dr., from March 31 to April 3, 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 April 15, 2025, response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence.During our inspection, our investigator observed specific violations including, but not limited to, the following.1. Your firm failed to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release. Your firm also failed to conduct, for each batch of drug product, appropriate laboratory testing, as necessary, required to be free of objectionable microorganisms (21 CFR 211.165(a) and 211.165(b)).Your firm failed to adequately test your over-the-counter (OTC) drug products, McD Foaming Antibacterial Hand Soap and McD Anti-Microbial Handwash, prior to release for distribution. Your batch records demonstrate that you do not always conduct finished product testing of the final bulk formulation. For example, in the manufacturing of McD Anti-Microbial Handwash batch 010726, you pulled a sample after phase A, but did not document whether you pulled a sample for final release testing. Additionally, you use(b)(4)water as a component in your drug products and do not perform any microbiological testing on either the water or finished drug product samples.In your response, you provide a sample retention procedure for testing in-process and finished product samples. You also indicate that you will test(b)(4)water samples for coliforms only. Your response is inadequate because your procedure does not specify whether you will include microbiological analysis in your release testing and does not address documentation of formulation adjustments. Furthermore, your water testing procedure is inadequate because it does not conform to the(b)(4)water USP monograph and does not specify appropriate microbiological limits.Drug product batches must be tested for identity, strength, and purity prior to release. Testing is essential to ensure that the drug products you manufacture conform to all predetermined quality attributes appropriate for their intended use. Without adequate finished product release testing, you do not have scientific evidence that each batch of drug product conforms to appropriate specifications before release.In response to this letter, provide:A list of chemical and microbial specifications, including test methods, used to analyze each lot of your drug products before a batch disposition decision.o An action plan and timelines for conducting full chemical and microbiological testing of reserve samples to determine the quality of all batches of drug products distributed to the United States that are within expiry as of the date of this letter.o A summary of all results obtained from testing reserve samples from each batch. If this testing reveals substandard quality drug products, take rapid corrective actions, such as notifying customers and product recalls.A procedure for your water system monitoring that specifies routine microbial testing of water to ensure its acceptability for use in each batch of drug products produced by your firm.2. Your firm failed to conduct at least one test to verify the identity of each component of a drug product (21 CFR 211.84(d)(1).You lacked adequate identity testing for your incoming components, including glycerin, used to manufacture your drug products. For example, your identity test method for glycerin did not include a limit test for the presence of diethylene glycol (DEG) and ethylene glycol (EG). You did not perform adequate identity testing using the USP identification test to detect these hazardous impurities in each shipment of each lot of glycerin you received. Therefore, you failed to assure the acceptability of the glycerin you used as a component of your drug products.In your response, you state you plan to use a contract lab that uses gas chromatography and mass spectrometry to perform the glycerin testing. Your response is inadequate because it fails to provide a detailed plan for how all your components, including glycerin, will be tested. You failed to include details on test methods and a review of compendial requirements, or a timeline for implementing the corrective actions proposed. Further, you did not consider a retrospective review of previously distributed OTC drug products.The use of ingredients contaminated with DEG or EG has resulted in various lethal poisoning incidents in humans worldwide. See FDA’s guidance documentTesting of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated Starch Hydrolysate, Sorbitol Solution, and Other High-Risk Drug Components for Diethylene Glycol and Ethylene Glycolto help you meet the CGMP requirements when manufacturing drugs containing ingredients at high-risk for DEG or EG contamination at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/testing-glycerin-propylene-glycol-maltitol-solution-hydrogenated-starch-hydrolysate-sorbitol.In response to this letter, provide:A description of how you will test each component lot for conformity with all appropriate specifications for identity, strength, quality, and purity. If you intend to accept any results from your supplier’s certificate of analysis instead of testing each component lot for strength, quality, and purity, specify how you will robustly establish the reliability of your supplier’s results through initial validation as well as periodic revalidation. In addition, include a commitment to always conduct at least one specific identity test for each incoming component lot. In the case of glycerin, propylene glycol, and certain additional high-risk components, we note that this includes the performance of parts A, B, and C of the USP monograph.The chemical quality control specifications you use to test each incoming lot of high-risk drug components to determine acceptability for use in manufacturing.A comprehensive, independent review of your material system to determine whether all suppliers of components, containers, and closures are each qualified and the materials are assigned appropriate expiration or retest dates. The review should also determine whether incoming material controls are adequate to prevent use of unsuitable components, containers, and closures.A summary of your program for qualifying and overseeing contract facilities that test the drug products you manufacture.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)).You failed to establish an adequate stability testing program to demonstrate that the chemical and microbiological properties of your drug products meets established specifications and remain acceptable through the 12-month expiration period for your drug products. During the inspection, you informed our investigator that reserve samples stored are also considered stability samples. You indicated that you only inspect them visually for color appearance and do not record the results.In your response, you commit to(b)(4)testing for chloroxylenol content. Your response is inadequate because it lacks sufficient detail about your stability program and does not indicate whether you will include microbiological analysis in this program. You also fail to indicate whether you are going to use validated stability indicating methods in your stability program.Without appropriate stability studies, you lack adequate scientific evidence to support whether your drug products meet established specifications and retain their quality attributes through their labeled expiry.In response to this letter, provide:A comprehensive, independent assessment and corrective action and preventive action (CAPA) plan to ensure the adequacy of your 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 drug product are added each year to the program to determine if the shelf-life claim remains valido Detailed definition of the specific attributes to be tested at each station (timepoint)o All procedures that describe these and other elements of your remediated stability program.4. Your firm’s quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP, and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22).Your quality unit (QU) did not provide adequate oversight for the manufacture of your OTC drug products. For example, your firm lacked standard operating procedures (SOPs) for QU responsibilities, investigations, change controls, CAPAs, recalls, reprocessing, and rejection of batches. Furthermore, your batch record for McD Antibacterial Hand Soap, lot 010726, is incomplete as you did not document the mixing time, lot numbers of the active ingredient used, and results from release testing.In your response, you provide an SOP, which simply lists QU responsibilities. The document lacks detail and does not demonstrate how your QU will ensure compliance with CGMP. Your response also does not include a comprehensive review of your quality system and SOPs, as well as a retrospective review of batch records to identify missing information and any errors.Your firm’s quality systems are inadequate. An adequate QU overseeing all manufacturing operations is necessary to consistently ensure drug quality. See FDA’s guidance documentQuality Systems approach to Pharmaceutical CGMP Regulationsfor help implementing quality systems and risk management approaches to meet the requirements of CGMP regulations 21 CFR parts 210 and 211 at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/quality-systems-approach-pharmaceutical-current-good-manufacturing-practice-regulations.In response to this letter, provide:A comprehensive assessment and remediation plan to ensure your QU is given the authority and resources to effectively function. The assessment should also include, but not be limited to:o A determination of whether procedures used by your firm are robust and appropriate.o Provisions for QU oversight throughout your operations to evaluate adherence to appropriate practices.o A complete and final review of each batch and its related information before the QU disposition decision.o Oversight and approval of investigations and discharging of all other QU duties to ensure identity, strength, quality, and purity of all products.o Also describe how top management supports quality assurance and reliable operations, including, but not limited to, timely provision of resources to proactively address emerging manufacturing/quality issues and to assure a continuing state of control.A complete assessment of documentation systems used throughout your manufacturing and laboratory operations to determine where documentation practices are insufficient. Include a detailed CAPA plan that comprehensively remediates your firm’s documentation practices to ensure you retain attributable, legible, complete, original, accurate, contemporaneous records throughout your operation.Consultant RecommendedBased upon the nature of the violations we identified at your firm, you should engage a consultant qualified as set forth in 21 CFR 211.34 to evaluate your operations and to assist your firm in meeting CGMP requirements.Your use of a consultant does not relieve your firm’s obligation to comply with CGMP. Your firm’s executive management remains responsible for resolving all deficiencies and systemic flaws to ensure ongoing CGMP compliance.ConclusionThe violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations.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 3000719870 and ATTN: Jamie Dion.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and Research

行政处罚案件信息摘要行政处罚决定书文号湘药监药罚〔2025〕38号当事人湖南省松龄堂中药饮片有限公司组织机构代码91430521748363223X法定代表人邓智华违法行为类型生产销售劣药荷叶案行政处罚内容该公司生产销售劣药荷叶的行为，违反《中华人民共和国药品管理法》第九十八条第一款的规定，依据《中华人民共和国药品管理法》第一百一十七条第一款、《中华人民共和国行政处罚法》第三十二条第一项及《药品监督管理行政处罚裁量适用规则》第十条第（二）项的规定，对该公司给予如下行政处罚：1.没收批号为231101，包装规格为50g/袋的荷叶23袋；2.没收违法所得6250.17元；3.处货值金额1倍罚款（药品货值金额不足十万元的，按十万元计算），计100000.00，罚没款合计106250.17元。作出行政处罚决定的行政机关湖南省药品监督管理局作出行政处罚决定的日期2025年10月30日行政处罚履行方式和期限收到本行政处罚决定书立即执行备注 相关附件： 相关阅读：

行政处罚案件信息摘要行政处罚决定书文号湘药监药罚〔2025〕52号当事人湖南天瑞医药有限公司组织机构代码91431000792392726X法定代表人刘斌违法行为类型销售劣药红参（红参片）案行政处罚内容该公司销售劣药红参（红参片）的行为，违反《中华人民共和国药品管理法》第九十八条第一款的规定，依据《中华人民共和国药品管理法》第一百一十七条第一款和《中华人民共和国药品管理法实施条例》第七十五条的规定，对该公司给予如下行政处罚：没收违法销售劣药红参（红参片）的违法所得3196.50元，免除其他行政处罚。作出行政处罚决定的行政机关湖南省药品监督管理局作出行政处罚决定的日期2025年10月27日行政处罚履行方式和期限收到本行政处罚决定书立即执行备注 相关附件： 相关阅读：

天津市药品监督管理局行政处罚决定书津药监（一办）罚〔2025〕14号 当事人：天津高领科技有限公司                    主体资格证照名称：  营业执照                    统一社会信用代码： 91120116MA076WEW4L           住所（住址）：天津经济技术开发区洞庭路220号天津国际生物医药联合研究院会议楼C407             法定代表人（负责人、经营者）：   顾振杰              身份证件号码：  ******                2025年8月8日，我局接到天津市医疗器械质量监督检验中心出具的《检验报告》（编号：2025-SC1-0015）及《天津市医疗器械抽验结果通知书》（编号：122503220026），显示当事人生产的多功能手术解剖器（电凝切割器）（注册证号：津械注准20232010270；批号：250402）不符合GB 9706.202-2021中201.12.2f）ME设备的可用性的标准要求：“具有一个以上插脚的手术连接器应有永久固定的脚距。禁止“飞线”连接。”，综合判定为不合格。2025年8月12日，执法人员对当事人送达《检验报告》，并进行了现场检查。当事人规定时限内未提出复检申请。2025年8月13日，我局予以立案调查。本案调查过程中，未对当事人采取行政强制措施。经查，当事人所生产的多功能手术解剖器（电凝切割器）（注册证号：津械注准20232010270；规格型号：DQDSB-330-ZQF-200-050-W00；批号：250402）经检验不符合强制性标准，该批产品共***件，其中留样***件，天津市医疗器械质量抽查检验***件，销售***件，未销售***件，召回***件。已销售产品销售价格为***元/件（含税），未销售产品当前销售价格为***元/件（含税），本案货值金额为13120元，违法所得为3600元。上述事实，主要有以下证据证明：1.当事人《营业执照》《医疗器械生产许可证》《多功能手术解剖器（电凝切割器）医疗器械注册证》《多功能手术解剖器（电凝切割器）医疗器械产品技术要求》复印件、法定代表人顾振杰身份证复印件、授权委托书及被委托人***、***身份证复印件，证明当事人主体资格。2.天津市医疗器械质量监督检验中心出具的《检验报告》（编号：2025-SC1-0015）、《天津市医疗器械抽验结果通知书》（编号：122503220026）、《天津市医疗器械抽检产品检验结果送达告知书》（编号：122503220026）、《医疗器械抽样记录及凭证（抽样编号：122503220026），证明案件来源及产品不符合强制性标准情况。3.现场笔录（2025年8月12日）、询问笔录（2025年8月20日），批号为250402、规格型号为DQDSB-330-ZQF-200-050-W00的多功能手术解剖器（电凝切割器）的批生产记录、成品放行通知单、物料卡、2025销售记录表、产品留样观察记录、成品出库单复印件，证明该批产品生产、检验、放行、留样、销售情况。4.询问笔录（2025年8月20日）、产品购销合同（合同编号：GL-X-2025011)、5张电子发票（增值税专用发票）（发票号码：25122000000045488103、25122000000058374185、25122000000058374289、25122000000046115561、25122000000058369158）复印件，证明已销售产品的实际销售价格及发票冲红情况。5.询问笔录（2025年8月20日）、产品购销合同（合同编号：GL-X-2025019)、1张电子发票（增值税专用发票）（发票号码：25122000000059334236）复印件、《降价说明》，证明该产品当前的市场销售价格。6.询问笔录（2025年8月20日）、《医疗器械召回时间报告表》《调查评估报告》《召回计划》《召回计划实施情况报告表》《召回产品批次信息表》、2张召回产品现场封存照片，证明当事人主动召回情况。7.《产品不合格项整改说明》《设计变更记录》、陕西省医疗器械质量检验院出具的《检验报告》（编号：W2025YD0250)、《风险评价文档》，证明当事人整改情况。8.《天津高领科技市抽抽检产品“不合格”问题的说明》《检验报告》（编号：2023-DL-0006）、《导线图纸及技术要求》《销售合同》及附件图纸，证明当事人多功能手术解剖器（电凝切割器）产品设计变更及检验情况。2025年10月16日，执法人员向当事人送达《天津市药品监督管理局行政处罚告知书》（津药监（一办）罚告〔2025〕14号）。当事人未提出陈述、申辩意见。 本局认为，当事人生产不符合强制性标准的医疗器械消融电极的行为违反了《医疗器械监督管理条例》第七条：“医疗器械产品应当符合医疗器械强制性国家标准；尚无强制性国家标准的，应当符合医疗器械强制性行业标准。”的规定。处罚依据为《医疗器械监督管理条例》第八十六条第一项“有下列情形之一的，由负责药品监督管理的部门责令改正，没收违法生产经营使用的医疗器械；违法生产经营使用的医疗器械货值金额不足1万元的，并处2万元以上5万元以下罚款；货值金额1万元以上的，并处货值金额5倍以上20倍以下罚款；情节严重的，责令停产停业，直至由原发证部门吊销医疗器械注册证、医疗器械生产许可证、医疗器械经营许可证，对违法单位的法定代表人、主要负责人、直接负责的主管人员和其他责任人员，没收违法行为发生期间自本单位所获收入，并处所获收入30%以上3倍以下罚款，10年内禁止其从事医疗器械生产经营活动：（一）生产、经营、使用不符合强制性标准或者不符合经注册或者备案的产品技术要求的医疗器械”的规定，及《中华人民共和国行政处罚法》第二十八条“行政机关实施行政处罚时，应当责令当事人改正或者限期改正违法行为。当事人有违法所得，除依法应当退赔的外，应当予以没收。违法所得是指实施违法行为所取得的款项。法律、行政法规、部门规章对违法所得的计算另有规定的，从其规定。”的规定。鉴于当事人接到不合格检验报告后积极配合调查，如实陈述违法事实，积极组织产品召回，主动提供生产记录、销售合同、发票等相关材料，积极整改，完成产品设计变更，并经检验，符合强制性标准要求。另当事人提交《天津高领科技市抽抽检产品“不合格”问题的说明》《检验报告》（编号：2023-DL-0006）、《导线图纸及技术要求》、《购销合同》及附件图纸，证明其不存在未按照经注册的产品技术要求组织生产的违法行为。以上情形符合《药品监督管理行政处罚裁量适用规则》第十条第（二）项“当事人有下列情形之一的，应当从轻或者减轻行政处罚：（二）主动消除或者减轻药品、医疗器械和化妆品违法行为危害后果的；”、第十一条第（二）项“当事人有下列情形之一的，可以从轻或者减轻行政处罚：（二）积极配合药品监督管理部门调查并主动提供证据材料的；”的情形，依据《中华人民共和国行政处罚法》第三十二条第（一）、（五）项“当事人有下列情形之一，应当从轻或者减轻行政处罚：（一）主动消除或者减轻违法行为危害后果的；（五）法律、法规、规章规定其应当从轻或者减轻行政处罚的”规定，对当事人给予减轻行政处罚。综上，当事人上述行为违反了《医疗器械监督管理条例》第七条的规定，依据《医疗器械监督管理条例》第八十六条第一项、《中华人民共和国行政处罚法》第二十八条、《中华人民共和国行政处罚法》第三十二条第（一）、（五）项的规定，现责令当事人立即改正上述违法行为，没收不符合强制性标准的多功能手术解剖器（电凝切割器）169件，没收违法所得3600元。当事人应于收到本行政处罚决定书之日起十五日内，将罚（没）款缴至银行或者通过电子支付系统缴纳（详见《天津市非税收入一般缴款书（缴款通知书）》）。逾期不缴纳罚款的，依据《中华人民共和国行政处罚法》第七十二条第一款第一项的规定，可每日按罚款数额的百分之三加处罚款。如你（单位）不服本行政处罚决定，可以在收到本行政处罚决定书之日起六十日内向天津市人民政府申请行政复议；也可以在六个月内依法向天津市红桥区人民法院提起行政诉讼。申请行政复议或者提起行政诉讼期间，行政处罚不停止执行。当事人在法定期限内不申请行政复议或者不提起行政诉讼，又不履行行政处罚决定的，我局可以申请人民法院强制执行。                 天津市药品监督管理局                  2025 年10月31日      （药品监督管理部门将依法向社会公开行政处罚决定信息）

天津市药品监督管理局行政处罚决定书津药监（一办）罚〔2025〕13号 当事人：天津高领科技有限公司                    主体资格证照名称：  营业执照                        统一社会信用代码：91120116MA076WEW4L                住所（住址）：天津经济技术开发区洞庭路220号天津国际生物医药联合研究院会议楼C407             法定代表人（负责人、经营者）：   顾振杰              身份证件号码：  ******               2025年6月27日，我局接到陕西省医疗器械质量检验院出具的《检验报告》（编号：GJ2025YD0013）及《2025年国家医疗器械抽检结果送达告知书》（编号：国抽送告（2025）010039AB号），显示当事人生产的消融电极（注册证号：津械注准20222010208；批号：250202）不符合GB 9706.202-2021中201.12.2f）ME设备的可用性的标准要求：“具有一个以上插脚的手术连接器应有永久固定的脚距。禁止“飞线”连接。”，综合判定为不合格。2025年7月3日，执法人员对当事人送达《检验报告》，并进行了现场检查。当事人规定时限内未提出复检申请。2025年7月9日，我局予以立案调查。本案调查过程中，未对当事人采取行政强制措施。经查，当事人所生产的消融电极（注册证号：津械注准20222010208；规格型号：DJ160S03；批号：250202）经检验不符合强制性标准，该批产品共***件，其中留样***件，国家医疗器械质量抽查检验***件，销售***件，召回***件。销售价格为***元/件（含税），本案货值金额为85750元，违法所得为53375元。上述事实，主要有以下证据证明：1.当事人《营业执照》《医疗器械生产许可证》《消融电极医疗器械注册证》《消融电极医疗器械产品技术要求》《消融电极使用说明书》复印件、法定代表人顾振杰身份证复印件、授权委托书及被委托人***、***身份证复印件，证明当事人主体资格。2.陕西省医疗器械质量检验院出具的《检验报告》（编号：GJ2025YD0013）、《2025年国家医疗器械抽检结果送达告知书》（编号：国抽送告（2025）010039AB号）、《医疗器械抽样记录及凭证》（抽样编号：1225301400306），证明案件来源及产品不符合强制性标准情况。3.现场笔录（2025年7月3日）、询问笔录（2025年8月20日），批号为250202、规格型号为DJ160S03的消融电极的批生产记录、成品放行通知单、物料卡、2025销售记录表、产品留样观察记录、成品出库单复印件，证明该批产品生产、检验、放行、留样、销售情况。4.询问笔录（2025年8月20日）、产品购销合同（合同编号：GL-X-2025006)、7张电子发票（增值税专用发票）（发票号码：25122000000019634467、25122000000058344331、25122000000058369150、25122000000028597441、25122000000058379309、25122000000046102911、25122000000058379313）复印件，证明该批产品实际销售价格及发票冲红情况。5.询问笔录（2025年8月20日）、《医疗器械召回时间报告表》《调查评估报告》《召回计划》《召回计划实施情况报告表》《召回产品批次信息表》、2张召回产品现场封存照片，证明当事人主动召回情况。6.《产品不合格项整改说明》《设计变更记录》、陕西省医疗器械质量检验院出具的《检验报告》（编号：W2025YD0250)、《风险评价文档》，证明当事人整改情况。7.《天津高领科技国抽抽检产品“不合格”问题的说明》《检验报告》（编号：2023-DL-0131）、《导线图纸及技术要求》3张、《购销合同》及附件图纸，证明当事人消融电极产品设计变更及检验情况。2025年10月16日，执法人员向当事人送达《天津市药品监督管理局行政处罚告知书》（津药监（一办）罚告〔2025〕13号）。当事人未提出陈述、申辩意见。 本局认为，当事人生产不符合强制性标准的医疗器械消融电极的行为违反了《医疗器械监督管理条例》第七条：“医疗器械产品应当符合医疗器械强制性国家标准；尚无强制性国家标准的，应当符合医疗器械强制性行业标准。”的规定。处罚依据为《医疗器械监督管理条例》第八十六条第一项“有下列情形之一的，由负责药品监督管理的部门责令改正，没收违法生产经营使用的医疗器械；违法生产经营使用的医疗器械货值金额不足1万元的，并处2万元以上5万元以下罚款；货值金额1万元以上的，并处货值金额5倍以上20倍以下罚款；情节严重的，责令停产停业，直至由原发证部门吊销医疗器械注册证、医疗器械生产许可证、医疗器械经营许可证，对违法单位的法定代表人、主要负责人、直接负责的主管人员和其他责任人员，没收违法行为发生期间自本单位所获收入，并处所获收入30%以上3倍以下罚款，10年内禁止其从事医疗器械生产经营活动：（一）生产、经营、使用不符合强制性标准或者不符合经注册或者备案的产品技术要求的医疗器械”的规定，及《中华人民共和国行政处罚法》第二十八条“行政机关实施行政处罚时，应当责令当事人改正或者限期改正违法行为。当事人有违法所得，除依法应当退赔的外，应当予以没收。违法所得是指实施违法行为所取得的款项。法律、行政法规、部门规章对违法所得的计算另有规定的，从其规定。”的规定。鉴于当事人接到不合格检验报告后积极配合调查，如实陈述违法事实，积极组织产品召回，主动提供生产记录、销售合同、发票等相关材料，积极整改，完成产品设计变更，并经检验，符合强制性标准要求。另当事人提交《天津高领科技国抽抽检产品“不合格”问题的说明》《检验报告》（编号：2023-DL-0131）、《导线图纸及技术要求》3张、《购销合同》及附件图纸，证明其不存在未按照经注册的产品技术要求组织生产的违法行为。以上情形符合《药品监督管理行政处罚裁量适用规则》第十条第（二）项“当事人有下列情形之一的，应当从轻或者减轻行政处罚：（二）主动消除或者减轻药品、医疗器械和化妆品违法行为危害后果的；”、第十一条第（二）项“当事人有下列情形之一的，可以从轻或者减轻行政处罚：（二）积极配合药品监督管理部门调查并主动提供证据材料的；”的情形，依据《中华人民共和国行政处罚法》第三十二条第（一）、（五）项“当事人有下列情形之一，应当从轻或者减轻行政处罚：（一）主动消除或者减轻违法行为危害后果的；（五）法律、法规、规章规定其应当从轻或者减轻行政处罚的”规定，对当事人给予减轻行政处罚。综上，当事人上述行为违反了《医疗器械监督管理条例》第七条的规定，依据《医疗器械监督管理条例》第八十六条第一项、《中华人民共和国行政处罚法》第二十八条、《中华人民共和国行政处罚法》第三十二条第（一）、（五）项的规定，现责令当事人立即改正上述违法行为，没收不符合强制性标准的医疗器械消融电极180件，没收违法所得53375元。当事人应于收到本行政处罚决定书之日起十五日内，将罚（没）款缴至银行或者通过电子支付系统缴纳（详见《天津市非税收入一般缴款书（缴款通知书）》）。逾期不缴纳罚款的，依据《中华人民共和国行政处罚法》第七十二条第一款第一项的规定，可每日按罚款数额的百分之三加处罚款。如你（单位）不服本行政处罚决定，可以在收到本行政处罚决定书之日起六十日内向天津市人民政府申请行政复议；也可以在六个月内依法向天津市红桥区人民法院提起行政诉讼。申请行政复议或者提起行政诉讼期间，行政处罚不停止执行。当事人在法定期限内不申请行政复议或者不提起行政诉讼，又不履行行政处罚决定的，我局可以申请人民法院强制执行。                 天津市药品监督管理局                  2025 年10月31日        （药品监督管理部门将依法向社会公开行政处罚决定信息）

　　根据2025年国家医疗器械抽检工作有关要求，我局对2025年度国抽医疗器械1批次不合格产品，及时组织人员开展了相关调查。现将核查处置情况通告如下：　　一、抽检基本情况　　2025年6月，我局执法人员在河南省昊德康医疗器械有限责任公司成品库，对该公司生产经颅磁刺激治疗仪（出厂编号：YZ20250424002)进行了国家医疗器械监督抽样。经天津市医疗器械质量监督检验中心初检，该批次产品“电压和（或）能量的限制”项目不符合“GB9706.1-2007”和“2025年国家医疗器械抽检品种检验方案”的有关要求。2025年8月，河南省昊德康医疗器械有限责任公司收到初检报告后，对初检结果提出复检申请。2025年10月，经北京市医疗器械检验研究院复检，该批次产品“电压和（或）能量的限制”项目仍不合格。　　二、核查处置情况　　河南省药品监督管理局第五监管分局依据《医疗器械监督管理条例》等有关规定，对河南省昊德康医疗器械有限责任公司生产的经颅磁刺激治疗仪（出厂编号：YZ20250424002)进行了核查处置。2025年10月，河南省药品监督管理局第五监管分局对河南省昊德康医疗器械有限责任公司作出罚款35000元的行政处罚（行政处罚决定书编号：豫药监械处罚〔2025〕5-3号），行政处罚案件信息已在政府网站公开。　　2025年11月5日

近期，太原市杏花岭区市场监管局根据线索查实，注册单位为山西百姓药房连锁有限公司富力城店、太原市五福大药房有限公司和太原鑫禾仁和大药房有限公司的执业药师（具体名单附后）与实际工作单位不一致，不能保证在岗执业，不能履行执业药师法定职责。依据《执业药师注册管理办法》第三十四条规定，撤销该3 人《执业药师注册证》。特此通告附件：拟撤销《执业药师注册证》人员名单山西省药品监督管理局2025年11月3日 附件拟撤销《执业药师注册证》人员名单序号姓  名执业药师注册单位执业药师注册证号1解慧卿山西百姓药房连锁有限公司富力城店1422240118752范晓瑞太原市五福大药房有限公司1422240122843苏景丽太原鑫禾仁和大药房有限公司141224011624

Product:DrugsRecipient:CosmenicPanamaIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesUnited StatesWARNING LETTERNovember 3, 2025Cosmenic:This is to advise you that the United States (U.S.) Food and Drug Administration (FDA) recently reviewed your website at the Internet address www.cosmenic.net and has observed that your website introduces into interstate commerce misbranded and unapproved new drugs in violation of sections 301(a), 301(d), 503(b), and 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. §§ 331(a), 331(d), 353(b), and 355(a)]. As discussed below, FDA has observed that www.cosmenic.net introduces into interstate commerce unapproved and misbranded injectable botulinum toxin drug products.There are inherent risks to consumers who purchase unapproved new drugs and misbranded drugs. Unapproved new drugs do not carry the same assurances of safety and effectiveness as those drugs subject to FDA oversight. Drugs that have circumvented regulatory safeguards may be contaminated, counterfeit, contain varying amounts of active ingredients, or contain different ingredients altogether. Furthermore, injectable drug products can pose a serious risk of harm to users because they bypass many of the body’s natural defenses against toxic ingredients, toxins, or dangerous organisms that can lead to serious and life-threatening conditions such as septicemia or sepsis. Accordingly, FDA requests that www.cosmenic.net cease offering any unapproved and misbranded drugs for sale to U.S. consumers. This is critical to shielding the American public from harm.Unapproved New Drugs:Certain products offered for sale by www.cosmenic.net are drugs within the meaning of section 201(g) of the FD&C Act [21 U.S.C. § 321(g)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or because they are intended to affect the structure or function of the body. These drugs are also new drugs as defined by section 201(p) of the FD&C Act [21 U.S.C. § 321(p)], because they are not generally recognized as safe and effective for their labeled uses. With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in section 505(a) of the FD&C Act [21 U.S.C. § 355(a)]. No approved applications pursuant to section 505 of the FD&C Act are in effect for these products. Accordingly, their introduction or delivery for introduction into interstate commerce violates sections 301(d) [21 U.S.C. § 331(d)] and 505(a) of the FD&C Act.An example of an unapproved botulinum toxin drug product you offer for sale on www.cosmenic.net is botulinum toxin type A marketed as “NABOTA® (JEUVEAU®) 100u”. Evidence obtained from your website establishing that this product is a drug intended for human use (as defined in 21 CFR 201.128) includes the claim “Botulinum toxin type A (Nabota) is indicated for the prevention of headaches in adults with chronic migraine.”While there are FDA-approved versions of botulinum toxin drug products on the market in the U.S., there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for “NABOTA® (JEUVEAU®) 100u” offered by www.cosmenic.net. Your marketing implies that your product is the same as the FDA-approved product, JEUVEAU®, when it is not. Currently there are several botulinum toxin products FDA-approved for the U.S. market, and these products are only available pursuant to a prescription from a licensed practitioner. In addition to JEUVEAU (prabotulinumtoxinA-xvfs), indicated for the temporary improvement in the appearance of glabellar lines, other examples of FDA-approved botulinum toxin products with a summary of their indications are: BOTOX® (onabotulinumtoxinA), indicated for the treatment of overactive bladder, neurogenic detrusor overactivity, chronic migraine, spasticity, cervical dystonia, severe primary axillary hyperhidrosis, strabismus, and blepharospasm and prophylaxis of headaches in adults with chronic migraines; DAXXIFY® (daxibotulinumtoxinA-lanm), indicated for the temporary improvement in the appearance of glabellar lines and the treatment of cervical dystonia; and MYOBLOC® (rimabotulinumtoxinB), indicated for the treatment of cervical dystonia and chronic sialorrhea.Furthermore, FDA-approved botulinum toxin drug products bear a boxed warning, commonly referred to as a “black box warning,” which is the strongest warning FDA requires, indicating that the drug carries a significant risk of serious or even life-threatening adverse effects. The boxed warning addresses the risk of distant spread of toxin effect to produce symptoms consistent with botulinum toxin effects. In addition, swallowing and breathing difficulties can be life threatening and there have been reports of death.Misbranded Drugs:A drug is misbranded under section 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)] if its labeling fails to bear adequate directions for use. “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (see 21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1) of the FD&C Act [21 U.S.C. § 353(b)(1)] include those that, because of their toxicity or other potentiality for harmful effect, and/or the method of their use, and/or the collateral measures necessary for their use, are not safe for use except under supervision of a practitioner licensed by law to administer them. Prescription drugs, as defined in section 503(b)(1)(A) of the FD&C Act, can be used safely only at the direction, and under the supervision, of a licensed practitioner.Because the aforementioned drug is a prescription drug intended for conditions that are not amenable to self-diagnosis and treatment by a layperson, adequate directions cannot be written such that a layperson can use the products safely for their intended use. Consequently, the labeling for these drug products fail to bear adequate directions for use, causing them to be misbranded under section 502(f)(1) of the FD&C Act. In addition, because these drugs are not approved in the U.S., they are also not exempt under 21 CFR 201.115(a) from the requirements of section 502(f)(1) of the FD&C Act. By offering these drugs for sale to U.S. consumers, www.cosmenic.net is causing the introduction of misbranded drugs into interstate commerce in violation of section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].FDA is sending this warning letter to www.cosmenic.net because of the inherent risks to consumers who purchase misbranded and unapproved new drugs. This letter is not intended to identify all the ways in which your products or operations might be in violation of the law. It is your responsibility to ensure that all products you offer for sale are in compliance with the FD&C Act and its implementing regulations. You should take prompt action to address any violations of the FD&C Act (which may include the offer for sale of similarly misbranded and/or unapproved new drugs other than the drug products noted above). We advise you to review your websites, product labels, and other labeling and promotional materials to ensure that you are not misleadingly representing your products as safe and effective for a use for which they have not been approved by FDA and that you are not distributing misbranded and unapproved drug products in violation of the FD&C Act.Please notify this office in writing within 15 working days describing the specific steps you have taken to address any violations and to prevent their recurrence. Include an explanation of each step being taken to remedy and prevent the recurrence of any violations, as well as copies of related documentation. Failure to adequately address this matter may result in legal action, including, without limitation, seizure, and injunction, without further notice. If you cannot complete corrective action within 15 working days, state the reason for the delay and the time within which you will complete the corrections. This letter notifies you of our concerns and provides you with an opportunity to address them. 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 within 15 working days.If you are not located in the U.S., please note that products that appear to be misbranded or unapproved new drugs may be detained or refused admission. We may advise the appropriate regulatory officials in the country from which you operate that your products referenced above appear to be unapproved and misbranded products that cannot be legally sold to consumers in the U.S.Please direct your response and any inquiries to FDA at FDAInternetPharmacyTaskForce-CDER@fda.hhs.gov.Sincerely,/S/Sangeeta Vaswani Chatterjee, Pharm.D.Acting DirectorOffice of Drug Security, Integrity, and ResponseOffice of ComplianceCenter for Drug Evaluation and Research

Product:DrugsRecipient:Dermacare dba Filler OutletSouth KoreaIssuing Office:Center for Drug Evaluation and Research (CDER)United States United StatesWARNING LETTERNovember 3, 2025Dermacare dba Filler Outlet:This is to advise you that the United States (U.S.) Food and Drug Administration (FDA) recently reviewed your website at the Internet address www.filleroutlet.com and has observed that your website introduces into interstate commerce misbranded and unapproved new drugs in violation of sections 301(a), 301(d), 503(b), and 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. §§ 331(a), 331(d), 353(b), and 355(a)]. As discussed below, FDA has observed that www.filleroutlet.com introduces into interstate commerce unapproved and misbranded injectable botulinum toxin drug products.There are inherent risks to consumers who purchase unapproved new drugs and misbranded drugs. Unapproved new drugs do not carry the same assurances of safety and effectiveness as those drugs subject to FDA oversight. Drugs that have circumvented regulatory safeguards may be contaminated, counterfeit, contain varying amounts of active ingredients, or contain different ingredients altogether. Furthermore, injectable drug products can pose a serious risk of harm to users because they bypass many of the body’s natural defenses against toxic ingredients, toxins, or dangerous organisms that can lead to serious and life-threatening conditions such as septicemia or sepsis. Accordingly, FDA requests that www.filleroutlet.com cease offering any unapproved and misbranded drugs for sale to U.S. consumers. This is critical to shielding the American public from harm.Unapproved New Drugs:Certain products offered for sale by www.filleroutlet.com are drugs within the meaning of section 201(g) of the FD&C Act [21 U.S.C. § 321(g)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or because they are intended to affect the structure or function of the body. These drugs are also new drugs as defined by section 201(p) of the FD&C Act [21 U.S.C. § 321(p)], because they are not generally recognized as safe and effective for their labeled uses. With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in section 505(a) of the FD&C Act [21 U.S.C. § 355(a)]. No approved applications pursuant to section 505 of the FD&C Act are in effect for these products. Accordingly, their introduction or delivery for introduction into interstate commerce violates sections 301(d) [21 U.S.C. § 331(d)] and 505(a) of the FD&C Act.An example of an unapproved botulinum toxin drug product you offer for sale on www.filleroutlet.com is botulinum toxin type A marketed as “Innotox 50u” and “innotox 50 units”. Evidence obtained from your website establishing that this product is a drug intended for human use (as defined in 21 CFR 201.128) includes the claims “The product has been shown to help reduce hyperhidrosis, or excessive sweating, offering a solution for individuals dealing with this issue” and “the product can also be used to treat involuntary eyelid twitching, providing relief for those with this condition.”While there are FDA-approved versions of botulinum toxin drug products on the market in the U.S., there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for “Innotox 50u” and “innotox 50 units” offered by www.filleroutlet.com. Currently there are several botulinum toxin products FDA-approved for the U.S. market and these products are only available pursuant to a prescription from a licensed practitioner. Examples of FDA-approved botulinum toxin products with a summary of their indications are: BOTOX® (onabotulinumtoxinA), indicated for the treatment of overactive bladder, neurogenic detrusor overactivity, chronic migraine, spasticity, cervical dystonia, severe primary axillary hyperhidrosis, strabismus, and blepharospasm and prophylaxis of headaches in adults with chronic migraines; DAXXIFY® (daxibotulinumtoxinA-lanm), indicated for the temporary improvement in the appearance of glabellar lines and the treatment of cervical dystonia; and MYOBLOC® (rimabotulinumtoxinB), indicated for the treatment of cervical dystonia and chronic sialorrhea.Furthermore, FDA-approved botulinum toxin drug products bear a boxed warning, commonly referred to as a “black box warning,” which is the strongest warning FDA requires, indicating that the drug carries a significant risk of serious or even life-threatening adverse effects. The boxed warning addresses the risk of distant spread of toxin effect to produce symptoms consistent with botulinum toxin effects. In addition, swallowing and breathing difficulties can be life threatening and there have been reports of death.Misbranded Drugs:A drug is misbranded under section 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)] if its labeling fails to bear adequate directions for use. “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (see 21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1) of the FD&C Act [21 U.S.C. § 353(b)(1)] include those that, because of their toxicity or other potentiality for harmful effect, and/or the method of their use, and/or the collateral measures necessary for their use, are not safe for use except under supervision of a practitioner licensed by law to administer them. Prescription drugs, as defined in section 503(b)(1)(A) of the FD&C Act, can be used safely only at the direction, and under the supervision, of a licensed practitioner.Because the aforementioned drug is a prescription drug intended for conditions that are not amenable to self-diagnosis and treatment by a layperson, adequate directions cannot be written such that a layperson can use the products safely for their intended use. Consequently, the labeling for these drug products fail to bear adequate directions for use, causing them to be misbranded under section 502(f)(1) of the FD&C Act. In addition, because these drugs are not approved in the U.S., they are also not exempt under 21 CFR 201.115(a) from the requirements of section 502(f)(1) of the FD&C Act. By offering these drugs for sale to U.S. consumers, www.filleroutlet.com is causing the introduction of misbranded drugs into interstate commerce in violation of section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].FDA is sending this warning letter to www.filleroutlet.com because of the inherent risks to consumers who purchase misbranded and unapproved new drugs. This letter is not intended to identify all the ways in which your products or operations might be in violation of the law. It is your responsibility to ensure that all products you offer for sale are in compliance with the FD&C Act and its implementing regulations. You should take prompt action to address any violations of the FD&C Act (which may include the offer for sale of similarly misbranded and/or unapproved new drugs other than the drug products noted above). We advise you to review your websites, product labels, and other labeling and promotional materials to ensure that you are not misleadingly representing your products as safe and effective for a use for which they have not been approved by FDA and that you are not distributing misbranded and unapproved drug products in violation of the FD&C Act.Please notify this office in writing within 15 working days describing the specific steps you have taken to address any violations and to prevent their recurrence. Include an explanation of each step being taken to remedy and prevent the recurrence of any violations, as well as copies of related documentation. Failure to adequately address this matter may result in legal action, including, without limitation, seizure, and injunction, without further notice. If you cannot complete corrective action within 15 working days, state the reason for the delay and the time within which you will complete the corrections. This letter notifies you of our concerns and provides you with an opportunity to address them. 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 within 15 working days.If you are not located in the U.S., please note that products that appear to be misbranded or unapproved new drugs may be detained or refused admission. We may advise the appropriate regulatory officials in the country from which you operate that your products referenced above appear to be unapproved and misbranded products that cannot be legally sold to consumers in the U.S.Please direct your response and any inquiries to FDA at FDAInternetPharmacyTaskForce-CDER@fda.hhs.gov.Sincerely,/S/Sangeeta Vaswani Chatterjee, Pharm.D.Acting DirectorOffice of Drug Security, Integrity, and ResponseOffice of ComplianceCenter for Drug Evaluation and Research

根据2024年海南省药品抽检计划以及日常监督抽检要求，海南省药品监督管理局于7至9月共组织完成112批次药品检验，其中，111批次药品检验符合规定。现将抽检不符合规定情况通告如下：一、在洋浦永敬堂民康大药房抽取的1批次乳酸菌素片不符合规定，不符合规定项目为重量差异。二、对上述不符合规定药品，药品监督管理部门已要求相关企业采取暂停销售使用、召回等风险控制措施，对不符合规定原因开展调查并切实进行整改。三、海南省药品监督管理局要求相关药品执法部门依据《中华人民共和国药品管理法》，组织对相关企业存在的涉嫌违法行为立案调查，并按规定公开查处结果。特此通告。附件：1.批次不符合规定药品名单2.不符合规定项目的小知识                                           海南省药品监督管理局            2024年11月4日附件11批次不符合规定药品名单药品名称批号规格检品来源标示生产企业抽样环节检验依据检验结论不符合规定项目检验机构乳酸菌素片230615按乳酸菌素计0.2克洋浦永敬堂民康大药房黑龙江百泰药业有限公司经营中华人民共和国卫生部药品标准二部第六册不符合规定重量差异海南省检验检测研究院儋州分所附件2不符合规定项目的小知识重量差异系反映药物均匀性的指标，是保证准确给药的重要参数之一。