行政相对人名称北安市益寿堂药品有限责任公司行政相对人代码(统一社会信用代码)91231181MA19130C9F法定代表人蒋丹丹行政处罚决定书文号北安市监处罚〔2025〕25号违法行为类型药品零售企业未按规定凭处方销售处方药的行为违法事实经查实，北安市益寿堂药品有限责任公司未按规定凭处方销售处方药情况属实。处罚依据《药品经营和使用质量监督管理办法》 / 第六十六条 / 第二款　　违反本办法规定，主动消除或者减轻违法行为危害后果的;违法行为轻微并及时改正，没有造成危害后果的;初次违法且危害后果轻微并及时改正的，依据《中华人民共和国行政处罚法》第三十二条、第三十三条规定从轻、减轻或者不予处罚。有证据足以证明没有主观过错的，不予行政处罚。;《药品经营和使用质量监督管理办法》 / 第七十二条 / 第一项　　　　药品零售企业有以下情形之一的，由药品监督管理部门责令限期改正；逾期不改正的，处五千元以上五万元以下罚款；造成危害后果的，处五万元以上二十万元以下罚款：　　（一）未按规定凭处方销售处方药的；处罚类别罚款处罚内容1.罚款人民币2000元。罚款金额（万元）0.2处罚决定日期2025-03-05处罚有效期2027-03-05公示截止期2028-03-05处罚机关北安市市场监督管理局相关推荐CIO提供以下相关文库下载、合规服务以及线上培训课程学习。

行政相对人名称黑龙江省盛特嘉医药连锁有限公司黑河康泰佳店行政相对人代码(统一社会信用代码)91231181MA1C52GY2N法定代表人徐保达行政处罚决定书文号北安市监处罚〔2025〕24号违法行为类型药品零售企业未按规定凭处方销售处方药的行为违法事实经查实，黑龙江省盛特嘉医药连锁有限公司黑河康泰佳店未按规定凭处方销售处方药情况属实。处罚依据《药品经营和使用质量监督管理办法》 / 第六十六条 / 第二款　　违反本办法规定，主动消除或者减轻违法行为危害后果的;违法行为轻微并及时改正，没有造成危害后果的;初次违法且危害后果轻微并及时改正的，依据《中华人民共和国行政处罚法》第三十二条、第三十三条规定从轻、减轻或者不予处罚。有证据足以证明没有主观过错的，不予行政处罚。;《药品经营和使用质量监督管理办法》 / 第七十二条 / 第一项　　　　药品零售企业有以下情形之一的，由药品监督管理部门责令限期改正；逾期不改正的，处五千元以上五万元以下罚款；造成危害后果的，处五万元以上二十万元以下罚款：　　（一）未按规定凭处方销售处方药的；处罚类别罚款处罚内容1.罚款人民币2000元。罚款金额（万元）0.2处罚决定日期2025-03-05处罚有效期2027-03-05公示截止期2028-03-05处罚机关北安市市场监督管理局相关推荐CIO提供以下相关文库下载、合规服务以及线上培训课程学习。

行政相对人名称×××公司行政相对人类别法人行政相对人代码_1(统一社会信用代码)×××法定代表人×××法定代表人证件类型身份证法定代表人证件号码×××行政处罚决定书文号粤药监药罚〔2025〕2001号违法行为类型生产销售不符合标准规定的药品违法事实经查，广州××有限公司委托××××有限公司于2023年12月7日生产的菠萝蛋白酶肠溶片（批号：231207，规格：6片/板×2板/盒），经广东省药品检验所检验和复验，检验项目“崩解时限”不符合国家药品监督管理局国家药品标准WS1-XG-046-2000的规定。该批次生产总量为41200盒，销售价格从8元/盒至48元/盒，涉案药品货值367560元；除留样375盒外，从客户退回和召回39028盒，库存1950盒，销售1797盒，销售金额为25836元，违法所得25836元。处罚依据《药品管理法》第一百一十七条第一款、《药品监督管理行政处罚裁量适用规则》第十条第一款第（二）项和第十一条第（二）项处罚类别罚款、没收违法所得、没收违法生产的药品处罚内容1.没收违法生产的菠萝蛋白酶肠溶片（批号：231207，规格：6片/板×2板/盒）1950盒；2.没收违法所得人民币25836元；3.罚款人民币400000元（人民币肆拾万元）。上述罚没款合计人民币425836元（人民币肆拾贰万伍仟捌佰叁拾陆元）。罚款金额（万元）40没收违法所得、没收非法财物的金额（万元）2.5836处罚决定日期2025年2月6日处罚有效期10年处罚机关广东省药品监督管理局处罚机关统一社会信用代码11440000MB2D034421数据来源单位广东省药品监督管理局数据来源单位统一社会信用代码11440000MB2D034421相关推荐CIO提供以下相关文库下载、合规服务以及线上培训课程学习。

广西蓝正药业有限责任公司：本局于2025年1月7日向你（单位）作出《行政处罚决定履行催告书》（桂药监稽催〔2025〕1号），因采取其他送达方式无法送达你（单位），依据《市场监督管理行政处罚程序规定》第八十二条第五项的规定，本局决定依法向你（单位）公告送达，内容是：1.没收违法所得贰万玖仟玖佰柒拾伍元贰角壹分（￥29975.21）；2.罚款贰拾万元整（￥200000.00）；3.加处罚款贰拾万元整（￥200000.00）。以上罚没款合计：肆拾贰万玖仟玖佰柒拾伍元贰角壹分（￥429975.21）。请你（单位）自本公告发布之日起三十日内到本局领取《行政处罚决定履行催告书》（桂药监稽催〔2025〕1号），逾期不领取即视为送达。你（单位）可以对本送达公告进行陈述和申辩。如对本公告不服，可以在收到本公告之日起60日内向自治区人民政府申请行政复议；也可以在6个月内依法向南宁铁路运输法院提起行政诉讼。联系人及电话：覃炎安、蓝憬，07715303902。联系地址：南宁市青秀区云景路32号。广西壮族自治区药品监督管理局2025年3月4日相关推荐CIO提供以下相关文库下载、合规服务以及线上培训课程学习。

序号行政处罚决定书文号违法企业名称或自然人姓名法定代表人姓名违法企业组织机构代码违法行为类型主要违法事实行政处罚的内容行政处罚的依据履行方式和期限作出处罚决定的行政机关和日期1鄂药监恩施信用修复告〔2025〕1号时珍堂巴东药业有限公司李晓鹤914228237641428772生产、销售劣药该公司生产劣药的行为违反了《药品管理法》第九十八条第一款、第三款第（七）项的规定，按照《药品管理法》第一百一十七条第一款的规定予以处罚。1.没收召回的该批次白鲜皮（批号：23112702），没收违法所得；2.处罚款。《药品管理法》第一百一十七条第一款的规定予以处罚主动履行，当事人收到行政处罚决定书之日起十五日内湖北省药品监督管理局2025年02月24日相关推荐CIO提供以下相关文库下载、合规服务以及线上培训课程学习。

安徽省药监局医疗器械生产监督检查信息通告（2025年2月）序号监督检查企业名称企业类别检查方式检查结论组织单位检查时间1安徽巨目光学科技股份有限公司二类日常检查基本符合省局第七分局2025-02-142芜湖市泰利齿科制作中心二类日常检查基本符合省局第七分局2025-02-173阜阳市华兴义齿有限公司二类日常检查基本符合省局第三分局2025-02-184合肥和正医疗科技有限公司二类日常检查基本符合省局第一分局2025-02-195合肥康居人医疗器械科技股份有限公司二类飞行检查基本符合省局第一分局2025-02-196安徽臻橙科技有限公司二类日常检查不符合省局第七分局2025-02-197阜阳市鸿利义齿有限责任公司二类日常检查基本符合省局第三分局2025-02-208黄山唯叶医疗器械有限公司二类日常检查基本符合省局第八分局2025-02-249芜湖圣大医疗器械技术股份有限公司二类日常检查基本符合省局第七分局2025-02-2410合肥安恒光电有限公司三类飞行检查基本符合省局第一分局2025-02-2511黄山杰冠齿科技术有限公司二类专项检查基本符合省局第八分局2025-02-2612安徽康齿健医疗科技有限公司二类日常检查基本符合省局第三分局2025-02-2713安徽达健医学科技有限公司三类飞行检查基本符合省局第七分局2025-02-28相关推荐CIO提供以下相关文库下载、合规服务以及线上培训课程学习。

序号行政处罚决定书文号违法企业名称或自然人姓名法定代表人姓名违法企业组织机构代码违法行为类型主要违法事实行政处罚的内容行政处罚的依据履行方式和期限作出处罚决定的行政机关和日期1鄂药监汉江械处罚〔2025〕2号仙桃市年年防护用品有限公司黄小雨91429004MA49EPWC9W生产、经营不符合经注册的产品技术要求的医疗器械当事人生产、经营不符合经注册的产品技术要求的医疗器械的行为，涉嫌违反了《医疗器械监督管理条例》第三十五条第一款的规定。1.没收违法所得；2.罚款。《中华人民共和国行政处罚法》第二十八条第二款和《医疗器械监督管理条例》第八十六条第一项的规定主动履行，当事人收到行政处罚决定书之日起十五日内湖北省药品监督管理局2025年03月05日相关推荐CIO提供以下相关文库下载、合规服务以及线上培训课程学习。

行政相对人名称张家港华夏帽业有限公司行政相对人类别法人及非法人组织统一社会信用代码91320582736521343F工商注册号组织机构代码税务登记号事业单位证书号社会组织登记证号法定代表人包仁高法定代表人证件类型法定代表人证件号码证件类型证件号码行政处罚决定书文号苏药监（苏）械罚〔2024〕023号违法行为类型违反了《医疗器械监督管理条例》第86条违法事实2024年8月19日，江苏省药监局苏州检查分局收到省局转来的河北省药品医疗器械检验研究院检验报告（报告编号：HBQX202400464）。报告显示该公司生产的医用防护口罩（规格型号：折叠挂耳式118mm*108mm、批号：KF202212006）的尺寸项目不符合技术要求。该单位收到上述不合格报告后申请了复检。经江西省医疗器械检测中心检验检验报告（报告编号：YQFY20240011）显示，上述产品的尺寸项目仍不符合，检验结论为：不符合产品技术要求。因此，该公司涉嫌生产不符合经注册的产品技术要求的医疗器械的行为违反了医疗器械相关法律法规，应立案调查。处罚依据《医疗器械监督管理条例》处罚类别罚款处罚内容罚款20000元罚款金额（万元）2.000000没收违法所得没收非法财物的金额（万元）暂扣或吊销证照名称及编号处罚决定日期2025/03/05处罚有效期2025/03/20公示截止期2026/03/05处罚机关江苏省药品监督管理局处罚机关统一社会信用代码11320000014000394R数据来源单位江苏省药品监督管理局数据来源单位统一社会信用代码11320000014000394R备注相关推荐CIO提供以下相关文库下载、合规服务以及线上培训课程学习。

行政相对人名称江苏飞澳斯医药集团有限公司行政相对人类别法人及非法人组织统一社会信用代码91321204791994661X工商注册号组织机构代码税务登记号事业单位证书号社会组织登记证号法定代表人汤志飞法定代表人证件类型身份证法定代表人证件号码3****************X证件类型证件号码行政处罚决定书文号17号违法行为类型销售劣药违法事实当事人经营的枸橼酸莫沙必利胶囊（批号：11323023，包装规格：24粒/盒，标示生产企业：上海新黄河制药有限公司）的【含量均匀度】项目不符合规定。处罚依据《药品管理法实施条例》（2019）第七十五条处罚类别没收违法所得、没收非法财物处罚内容没收违法所得646.8元，免除其他行政处罚罚款金额（万元）没收违法所得没收非法财物的金额（万元）0.06488暂扣或吊销证照名称及编号处罚决定日期2025/03/05处罚有效期2025/06/05公示截止期2025/06/05处罚机关江苏省药品监督管理局处罚机关统一社会信用代码11320000014000394R数据来源单位江苏省药品监督管理局数据来源单位统一社会信用代码11320000014000394R备注相关推荐CIO提供以下相关文库下载、合规服务以及线上培训课程学习。

Delivery Method:VIA EMAIL WITH READ RECEIPTReference #:320-25-44Product:DrugsRecipient:Mr. Jason ArcherGeneral ManagerChem-Tech, Ltd.1006 Business Highway 5P.O. Box 576Pleasantville,IA50225United StatesJArcher@neogen.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter320-25-44February 11, 2025Dear Mr. Archer:The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Chem-Tech, Ltd., FEI 1927341, at 1006 Business Highway 5, Pleasantville, IA, from September 17 to 20, 2024.This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations, 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 product is 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 October 11, 2024, response to our Form FDA 483 in detail. Your response is inadequate because you failed to provide supportive documentation for evaluation or adequate evidence of corrective actions taken to bring your operations into compliance with CGMP.During our inspection, our investigator observed specific violations including, but not limited to, the following.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).Your firm failed to conduct adequate manufacturing investigations into out-of-specification (OOS) results obtained by your external laboratory for your(b)(4), an over-the-counter (OTC) drug product. As such, root cause(s) for the OOS results were not determined and no corrective and preventive actions (CAPA) were identified.For example,Batch(b)(4)reported(b)(4)assay for(b)(4)content of 0.423% (specification,(b)(4)). Despite no supportive documentation from an investigation, you identified a separation issue as the root cause for the OOS result and failed to consider the batch was also outside the established(b)(4)hold time. The batch was reworked to adjust the(b)(4)content and released on March 22, 2022.Batch(b)(4)reported a(b)(4)assay for(b)(4)content of 0.246% (specification(b)(4)). Your deviation report indicated that the OOS was due to improper mixing without a full manufacturing investigation. You mixed the batch for(b)(4)as the corrective action. The batch was retested for assay and upon passing, the batch was released on July 7, 2023.In addition, your firm lacks mixing process validation and finished product hold time studies that are scientifically supported, as required by 21 CFR 211.110(a). For example, your validation report only includes the filling operation and does not include mixing parameters. The holding time was initially established as(b)(4)and changed to(b)(4)without supporting data. There is evidence that(b)(4)batch(b)(4)was held for up to 120 days prior to filling without additional testing. The extended hold time of the finished drug product and inadequate validation of the process may contribute to both the high- and low-OOS assay results reported, and your cursory investigation lacked appropriate CAPA.Without adequate manufacturing investigations, you lack sufficient evidence to determine if the process is contributing to the OOS results obtained. As a manufacturer, you have a responsibility to fully investigate OOS results and process deviations that may impact product quality.For more information about process validation and handling failing, OOS, out-of-trend, or other unexpected results and documentation of your investigations, see FDA’s guidance documents:Process Validation: General Principles and Practicesat https://www.fda.gov/media/71021/download andInvestigating Out-of-Specification (OOS) Test Results for Pharmaceutical Productionat https://www.fda.gov/media/158416/download.2. Your firm failed to clean, maintain, and sanitize and/or sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements, and you failed to establish and follow adequate written procedures for cleaning and maintenance of equipment (21 CFR 211.67(a) and (b)).You failed to maintain your drug manufacturing facility in a good state of repair. For example, your mixing tank and filling lines for your OTC drug product are in a large, unclean area. The investigator observed a layer of dirt and a dead insect on the lid of your mixing tank that was only partially covered by a plastic sheet. It is essential your facility is in a good state of repair, and sanitary conditions are maintained to ensure ongoing suitability for drug manufacturing and to protect the product from contamination.Additionally, the investigator observed leftover drug product pooled at the bottom of your mixing tank, along with orange-red discoloration on the inside walls and bottom of the mixing tank. You had last manufactured drug products on this equipment approximately 1 month prior and that you would(b)(4)and(b)(4)prior to starting a new manufacturing run. You have no validated cleaning procedure to demonstrate that this is sufficient to clean your equipment.Your firm also lacked a preventive maintenance program with procedures for maintenance and cleaning of equipment. For example, we noted that the meter used to charge potable water into the drug product has never been calibrated.3. Your firm failed to establish adequate written responsibilities and procedures applicable to the quality control unit and to follow written procedures applicable to the quality control unit (21 CFR 211.22(d)).Your firm’s quality unit failed to have procedures for GMP training, handling OOS results, and change management. In addition, the procedures for handling deviations and complaints are inadequate. For example, the deviations procedure lacks details for the investigation process, and the complaints procedure states they are managed by your firm’s only customer but lacks information about how your customer will communicate when complaints are received, the outcome, and any needed actions including CAPA.Your firm’s quality systems are inadequate. 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/media/71023/download.Drug RecallOn(b)(4), you issued a voluntary recall of(b)(4)due to GMP violations cited after the inspection conducted from September 17 to 20, 2024. The company announcement was posted to the FDA website:(b)(4)Drug Production CeasedWe acknowledge your commitment to cease production of(b)(4)drug at this facility.If you plan to resume any drug manufacturing operations, notify this office. You are responsible for resolving all deficiencies and systemic flaws to ensure your firm is capable of ongoing CGMP compliance. In your notification to the Agency, provide a summary of your remediations to demonstrate that you have appropriately completed all CAPA.CGMP Consultant RecommendedBased upon the nature of the violations we identified at your firm, you should engage a consultant qualified as set forth in 21 CFR 211.34 to evaluate your operations and to assist your firm in meeting CGMP requirements if your firm intends to resume manufacturing drugs for the U.S. market. The qualified consultant should also perform a comprehensive six-system audit1of your entire operation for CGMP compliance and evaluate the completion and efficacy of your corrective actions and preventive actions before you pursue resolution of your firm’s compliance status with FDA.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 1927341 and ATTN: Vilmary Negrón Rodríguez.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and Research_____________________1i.e. Quality System, Facilities & Equipment System, Materials System, Production System, Packaging & Labeling System, and Laboratory Control System per FDA’s guidance document Quality Systems Approach to Pharmaceutical CGMP Regulations.