按照《中华人民共和国药品管理法》《中华人民共和国行政许可法》和《药品经营和使用质量监督管理办法》等相关规定,根据河南鑫淼医药有限公司申请,现注销河南鑫淼医药有限公司的《药品经营许可证》(证书编号:豫AA393000314)。 特此公告。 附件:河南鑫淼医药有限公司《药品经营许可证》有关信息表 2026年6月22日附 件河南鑫淼医药有限公司《药品经营许可证》(批发)有关信息表企业名称法定代表人(负责人)主要负责人质量负责人经营方式经营范围经营地址仓库地址证书编号河南鑫淼医药有限公司李世绪刘俊贾文莉批发中药饮片、中成药(含冷藏药品)、化学药(含冷藏药品)、生物制品(含冷藏药品)、蛋白同化制剂、肽类激素(含冷藏药品)濮阳市新东路与锦湖路交叉口向北50米路西8号濮阳市新东路与锦湖路交叉口向北50米路西8号《药品经营许可证》(证号:豫AA393000314)
行政相对人名称亳州泽泓斋大药房(个人独资)行政相对人类别法人及非法人组织统一社会信用代码91341623MAG0F12M3R法定代表人-行政处罚决定书文号利市监处罚﹝2026﹞459号处罚类别罚款处罚决定日期2026-06-23处罚内容罚款3000元罚款金额(万元)0.300000没收违法所得、没收非法财物的金额(万元)0.000000暂扣或吊销证照名称及编号-违法行为类型《药品经营和使用质量监督管理办法》第四十二条第一款违法事实2026年03月10日,利辛县市场局执法人员对其经营场所进行检查时,发现其未凭处方销售处方药“细辛”,随给其下达责令改正通知书,要求其限期改正违法行为。2026年03月16日本局执法人员接到12345热线督办记录单(记录单编号:260314036840029)内容为:“花费47.21元购买抓配中药材,到货后发现雷公藤已移除中国药典,不属于药食同源,也不属于农副产品,中药饮片,商家违反《中华人民共和国药品管理法》和《医疗用毒性药品管理办法》,且雷公藤有毒不能随便售卖,对此投诉,望部门核实查处并电话联系来电人。”,接投诉后,执法人员于当日对该店进行检查,经现场检查该店没有“雷公藤”,据其投资人称其在网上销售的“雷公藤”是在亳州购进,平时不备货,客户需要多少就购进多少。执法人员现场查看其京东商场经营的店铺,发现其销售有处方药“雷公藤”,并且未凭处方销售,当事人涉嫌存在未凭处方销售处方药的行为,被本局依法查获。至案发时,当事人共购进处方药“细辛”0.5kg(进价582元/kg,销价600元/kg),销售额300元;销售三幅雷公藤(投诉人购买),上述2种处方药销售额共计347.21元,违法所得11元。处罚依据《药品经营和使用质量监督管理办法》第七十二条第一款第一项处罚机关利辛县市场监督管理局处罚机关统一社会信用代码11341623098775401G数据来源单位安徽省药品监督管理局数据来源单位统一社会信用代码11340000MB19570665
行政相对人名称:平塘县人民医院行政相对人代码_1(统一社会信用代码):12522727430310121H行政相对人代码_2(工商注册号):行政相对人代码_3(组织机构代码):行政相对人代码_4(税务登记号):行政相对人代码_5(事业单位证书号):行政相对人代码_6(社会组织登记证号):行政相对人类别:法人及非法人组织行政处罚决定文书号:平医保罚字〔2026〕第004号违法行为类型:医疗机构重复收费违法行为违法事实:平塘县人民医院口腔科门诊在为患者开展牙体缺损粘接修补术时,已收取牙体缺损粘接修补术费用,同时收取简单充填术或复杂充填术费用,存在重复收费的违法违规问题,造成医保基金损失11175.11元(其中城乡居民医保10204.60元、城镇职工医保970.51元)。处罚依据:《医疗保障基金使用监督管理条例》第三十八条第(三)项;《贵州省医疗保障行政处罚裁量权基准适用办法》第二章第九条第(5)项处罚类别:罚款处罚内容:1.责令平塘县人民医院立即整改重复收费违法行为,约谈医院负责人; 2.责令退回违规医保基金11175.11元(其中城乡居民医保10204.60元、城镇职工医保970.51元); 3.处医保基金损失金额1倍罚款,合计11175.11元。处罚金额(元):11175.110000没收违法所得、没收非法财务金额(元):暂扣或吊销证称及编号:处罚决定日期:2026-06-17处罚有效期:2029-06-17公示截止日期:2027-06-17处罚机关:平塘县医疗保障局处罚机关统一社会信用代码:11522727MB1675368U数据来源单位:平塘县医疗保障局数据来源统一社会信用代码:11522727MB1675368U备注:入库日期:2026-06-23 16:35:23最后一次更新日期:2026-06-24 04:46:39公示日期:2026-06-23 16:35:23报送部门:平塘县医疗保障局
行政相对人名称:平塘县人民医院行政相对人代码_1(统一社会信用代码):12522727430310121H行政相对人代码_2(工商注册号):行政相对人代码_3(组织机构代码):行政相对人代码_4(税务登记号):行政相对人代码_5(事业单位证书号):行政相对人代码_6(社会组织登记证号):行政相对人类别:法人及非法人组织行政处罚决定文书号:平医保罚字〔2026〕第002号违法行为类型:医疗机构分解项目收费违法行为违法事实:2026年黔南州医保局飞行检查移交线索查实,平塘县人民医院开展经纤支镜肺泡灌洗诊疗术时,未严格执行黔价费〔2003〕127号医疗服务价格项目内涵规定,肺泡灌洗操作内含吸痰吸引配套操作,该院将同一诊疗行为拆分为经纤支镜肺泡灌洗诊疗术、经纤支镜治疗两个项目重复收费,涉案违规医保基金合计42683.65元(城镇职工医保3909.09元、城乡居民医保38774.56元)。处罚依据:1.《医疗保障基金使用监督管理条例》第三十八条第(三)项:定点医药机构分解项目收费,造成医疗保障基金损失的,由医疗保障行政部门责令改正,并可以处造成损失金额1倍以上2倍以下的罚款; 2.《贵州省医疗保障行政处罚裁量权基准适用办法》第二章第九条第(五)项:积极配合行政机关查处违法行为,如实陈述违法事实并主动提供证据材料,应当从轻或者减轻处罚。处罚类别:罚款处罚内容:1.责令当事人平塘县人民医院立即对分解项目收费违法违规问题全面整改,约谈医院主要负责人; 2.责令退回违规造成损失的医保基金共计42683.65元(其中城镇职工医保基金3909.09元、城乡居民医保基金38774.56元); 3.处医保基金损失金额1倍的罚款,罚款金额42683.65元。处罚金额(元):42683.650000没收违法所得、没收非法财务金额(元):暂扣或吊销证称及编号:处罚决定日期:2026-06-17处罚有效期:2029-06-17公示截止日期:2026-07-17处罚机关:平塘县医疗保障局处罚机关统一社会信用代码:11522727MB1675368U数据来源单位:平塘县医疗保障局数据来源统一社会信用代码:11522727MB1675368U备注:入库日期:2026-06-23 15:52:14最后一次更新日期:2026-06-24 04:46:39公示日期:2026-06-23 15:52:14报送部门:平塘县医疗保障局
行政相对人名称:贵阳市白云区白沙关社区卫生服务中心行政相对人代码_1(统一社会信用代码):52520113MJY32302XL行政相对人代码_2(工商注册号):行政相对人代码_3(组织机构代码):行政相对人代码_4(税务登记号):行政相对人代码_5(事业单位证书号):行政相对人代码_6(社会组织登记证号):行政相对人类别:法人及非法人组织行政处罚决定文书号:白医保罚字〔2026〕第11号违法行为类型:《医疗保障基金使用监督管理条例》第十五条“定点医药机构及其工作人员应当执行实名就医和购药管理规定,核验参保人员医疗保障凭证,按照诊疗规范提供合理、必要的医药服务,向参保人员如实出具费用单据和相关资料,不得分解住院、挂床住院,不得违反诊疗规范过度诊疗、过度检查、分解处方、超量开药、重复开药,不得重复收费、超标准收费、分解项目收费,不得串换药品、医用耗材、诊疗项目和服务设施,不得诱导、协助他人冒名或者虚假就医、购药。”以及第十四条“定点医药机构应当建立医疗保障基金使用内部管理制度,由专门机构或者人员负责医疗保障基金使用管理工作,建立健全考核评价体系。”的规定。违法事实:贵阳市白云区白沙关社区卫生服务中心存在过度检查、降低标准入院、医院内部控制制度落实不到位等违规问题。处罚依据:《医疗保障基金使用监督管理条例》第三十八条。处罚类别:罚款处罚内容:1.责令改正,约谈贵阳市白云区白沙关社区卫生服务中心有关负责人;2.处违规金额1倍罚款,即8665.32元。处罚金额(元):8665.320000没收违法所得、没收非法财务金额(元):暂扣或吊销证称及编号:处罚决定日期:2026-06-22处罚有效期:2027-06-22公示截止日期:2027-06-22处罚机关:贵阳市白云区医疗保障局处罚机关统一社会信用代码:11520113MB1658664M数据来源单位:贵阳市白云区医疗保障局数据来源统一社会信用代码:11520113MB1658664M备注:入库日期:2026-06-23 14:34:04最后一次更新日期:2026-06-23 23:02:49公示日期:2026-06-23 14:34:04报送部门:贵阳市白云区医疗保障局
Delivery Method:Via Email Return Receipt RequestedReference #:320-26-81Product:DrugsRecipient:Mr. Christopher S. PretiPresident, Chief Executive OfficerJubilant HollisterStier General Partnership16751 Trans-Canada HighwayKirkland QC H9H 4J4CanadaIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter 320-26-81May 28, 2026Dear Mr. Preti:The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Jubilant HollisterStier General Partnership, FEI 3001623073, at 16751 Trans-Canada Highway, Kirkland, from October 20 to November 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 November 25, 2025, response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence.During our inspection, our investigators observed specific violations including, but not limited to, the following.1. 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 and sterilization processes (21 CFR 211.113(b)).A. Our inspection identified aseptic processing design deficiencies which pose significant hazards to drug product sterility, as well as multiple inadequacies in your smoke studies. For example:During a smoke study simulating an aseptic intervention of the (b)(4) line, an operator extended their upper body over the conveyor. This design flaw disrupted (b)(4) air and compromised protection of the critical ISO 5 zone. Smoke studies demonstrated air movement across the operator’s body and flowing toward exposed vials.You also performed a smoke study on the (b)(4) filling line to evaluate removal of vials from the (b)(4) at the (b)(4). During this study an operator (b)(4) the large (b)(4) and placed their upper torso inside the ISO 5 classified area. The operator also used gloved hands instead of sterile tools to remove vials.In order to (b)(4) the (b)(4), operators opened a small (b)(4) by reaching their entire forearm inside the ISO 5 classified area and manually turning a (b)(4).These and other hazardous interventions occurred at critical locations in your aseptic processing area. Any compromise of (b)(4) protection exposes sterile drug product to potential microbiological contamination.Our inspection also noted other deficient smoke studies. For example, the video evaluating connection of the (b)(4) to the (b)(4) demonstrated inadequate smoke at the site of the critical activity. However, despite the inadequate airflow visualization, you concluded the airflow was “Excellent.” We previously discussed inadequate smoke generation in our November 15, 2024, regulatory meeting with your firm.Your response states that the quality assurance unit at another Jubilant site will conduct a comprehensive assessment of your smoke studies with support from your third party consultants. You state you will identify interventions that represent the highest contamination risk and re-execute studies as needed.Your response is inadequate. You do not provide sufficient detail on the re-execution of smoke studies, nor do you ensure sufficient third party oversight responsibilities. You also do not address the risk insufficient smoke studies pose, including inadequate identification of hazards posed by the (b)(4), various manual activities, and intervention ergonomics.We acknowledge your firm’s long term commitment to improving your manufacturing operation, including, but not limited to, better quality oversight and replacing aging equipment with contemporary equipment, including restricted access barrier systems and (b)(4) systems.B. Your aseptic process simulations (media fills) failed to demonstrate the maximum duration of (b)(4) interventions observed during commercial aseptic filling operations. They also did not sufficiently represent the risk to your aseptic process posed by lengthy interventions.For example, the duration of (b)(4) was nearly (b)(4) for (b)(4) injection commercial batch (b)(4). In contrast, the (b)(4) simulation for (b)(4) during the (b)(4) media fill was between (b)(4). We also cited deficient aseptic process simulations during our February 2023 and June 2024 inspections. You have failed to adequately correct this deficiency.In your response, you mention that a reference published by an external technical organization did not specify that maximum duration of interventions must be simulated during media fills.Your response is inadequate. Lengthy (b)(4) interventions expose the aseptic processing line to high contamination risk. Including such interventions is integral to ensuring an accurate simulation of your operation. You do not adequately address the significant discrepancy between your simulated and actual intervention durations.Additionally, you state your media fills will “incorporate the longest intervention durations observed in commercial batches,” with a corrective action and preventive action (CAPA) plan due date of June 30, 2026. However, you provide no revised procedures in your response. Furthermore, your response fails to address the intervention and (b)(4) discrepancies cited in deviation PR 256484. It continues to be unclear whether the (b)(4) was actually simulated.C. During our inspection, we also observed (b)(4) discoloration on multiple (b)(4) surfaces below the HEPA filters and inside the (b)(4) filling line where (b)(4) sterile drug products are exposed.In your response, you acknowledge the observed discoloration and state that you opened a deviation. You state the root cause of the observed discoloration was due to a lack of specific provisions in room and equipment inspection criteria for evaluating the condition of light fixtures. You indicate that there is no drug product impact based on acceptable environmental monitoring results, successful media fills, and the absence of out-of-specification findings related to microbiological contamination or sterility.Additionally, you state that production, maintenance, and quality assurance representatives conducted a walkthrough of the Sterile Production Department to identify similar risks across other production zones but provide no further details of those assessments in the response.Your response is inadequate. You do not explain the cause of the (b)(4) discoloration, and you attribute the failure to a procedural gap. Additionally, your retrospective drug product impact assessment of distributed batches does not include a review of visible particulate inspection data to determine whether any rejected units contained (b)(4) particles or other unusual particles.In response to this letter, provide:Comprehensive, independent risk assessment by a qualified consultant of all contamination hazards with respect to your aseptic processes, equipment, and facilities, including but not limited to:o All human interactions within the ISO 5 area (e.g., risk reduction or elimination of manual interventions wherever possible)o Equipment placement and suitability, including ergonomics for each human interaction and sufficient cleanroom spaceo Air quality in the ISO 5 area and surrounding room including, but not limited to air volume and flow (e.g., review of smoke studies for each line)o Reduction or elimination of aseptic manipulationso Facility layouto Personnel Flow and Material Flow throughout all rooms used to conduct and support sterile operationsA detailed remediation plan from the independent consultant with timelines to address the findings of the contamination hazards risk assessment. Describe comprehensive improvements to be made to aseptic processing operation design and control for each aseptic processing line at your facility and explain how this CAPA plan will robustly remediate your deficient sterile manufacturing operations. Include comprehensive changes to the design of each of your aseptic processing lines and cleanrooms, the specific barrier system to be used (e.g., Restricted Access Barrier, (b)(4)), and associated timelines. Also, describe your plans for qualification and validation of your extensively remediated operations.Your systematic plan to assure adherence to appropriate aseptic practices, cleanroom behavior, and written procedures, including not but limited to, an independent assessment of the following with accompanying CAPA:o suitability of actual practices based on extensive retrospective review and prospective observation of aseptic processing operations;o deficiencies in production management oversight and identification of specific improvements to ensure effective and routine supervisory oversight for all batches;o frequency and depth of quality unit oversight (e.g., audit, ad hoc, daily interactions) of aseptic processing and its support operations;o adequacy of written procedures;o the risk assessment should also evaluate how poor aseptic technique and cleanroom behavior may have affected the quality and sterility of your drugs.Deviation and CAPA reports related to the (b)(4) discoloration on the light fixtures in the aseptic core, and any steps taken to ensure suitability of the environment after replacement of the fixtures. Provide the assessment results of the walkthrough of the Sterile Production Department that was conducted to identify whether similar deficiencies existed.Your CAPA plan to implement routine, vigilant operations management oversight of facilities and equipment. This plan should ensure, among other things, prompt detection of equipment/facilities performance issues, effective execution of repairs, adherence to appropriate preventive maintenance schedules, timely technological upgrades to the equipment/facility infrastructure, and improved systems for ongoing management review. Your plan should also ensure that appropriate actions are taken throughout the company network.2. 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 lacked adequate systems to ensure sufficient and timely investigations.A. Your firm failed to investigate multiple action-level environmental monitoring excursions that occurred between January and June 2025 in the ISO 5 and 7 areas. Your environmental monitoring revealed an adverse trend of mold recoveries on personnel for the months of February, March, May, and June. However, you did not open a trend investigation until August 27, 2025.For example, you recovered 83 colony forming units, including mold, from sampling an operator’s neck in the ISO 7 area in (b)(4). Your action level is (b)(4) or more colony forming units, but you did not initiate a deviation investigation.Notably, there were multiple additional instances of excessively high microbial counts recovered from cleanroom personnel during this period.You continued to not conduct investigations of environmental monitoring action level excursions in “non-product related” areas (ISO 7 and ISO 8), such as gowning rooms and corridors. We previously discussed this insufficient oversight of environmental control in our November 15, 2024, regulatory meeting. Your failure to promptly investigate these excursions may allow microbiological contamination hazards to persist and worsen in your classified areas.In your response, you state investigations were not opened because two former microbiology supervisors incorrectly advised personnel that non-product-related excursions did not require investigation initiation. You also note that you have rejected (b)(4) batches in response to significant environmental monitoring deviations, and you have extended your shutdown to continue until you verify remediations to aseptic processing facility control including improved gowning, cleanroom behavior, and environmental monitoring.We acknowledge these efforts. However, your response does not adequately address the responsibility of your quality unit to ensure procedures are followed and environmental monitoring excursions are appropriately investigated.B. Your investigation into visible particulate (e.g. (b)(4)) contamination of (b)(4) batches of (b)(4) was not conducted in a timely manner. You opened the investigation on June 4, 2025, and the status of the investigation on November 3, 2025, five months later, was still in progress. You continued to manufacture additional batches on the same processing line without definitive root causes identified.In your response, you note that at the time of our inspection you were continuing to investigate the visible particulate and assess its impact on the batches. You state you notified the application holder about the particulate contamination and took several corrective actions. These include establishing a new quality operations position to oversee investigations and deviation management, and increasing personnel to reduce the deviation backlog. You also provided awareness training to staff and are requiring all deviations to be initiated using TrackWise software. Additionally, you state you placed an inventory block on the implicated stopper lot that may have contributed to the visible particulate contamination.Your response is inadequate. Your response does not confirm whether the particulate investigation is complete, nor does it provide an updated investigation report including your final root cause analysis and all associated actions taken by your firm.In response to this letter, provide:A comprehensive, independent assessment of your overall system for investigating deviations, discrepancies, complaints, out-of-specification results, out-of-limit (e.g., action limits), and failures. Provide a detailed action plan to remediate this system. Your action plan should include, but not be limited to, significant improvements in investigation competencies, scope determination, root cause evaluation, CAPA effectiveness, quality assurance oversight, and written procedures. Address how your firm will ensure all phases of investigations are appropriately conducted.An independent assessment and remediation plan for your CAPA program. Provide a report that evaluates whether the program includes effective root cause analysis, ensures CAPA effectiveness, analyses investigation trends, improves the CAPA program when needed, implements final quality assurance decisions, and is fully supported by executive management.A summary of updated deviations and related CAPA reports. Provide effectiveness checks for the adverse trend in mold recoveries.A drug product impact assessment of the particulate contamination and your associated investigation.Ineffective Quality SystemSignificant findings in this letter demonstrate that your firm does not operate an effective quality system in accord with CGMP. In addition to the lack of effective management oversight of your production operations, we found your quality unit is not enabled to exercise proper authority and/or has insufficiently implemented its responsibilities. Executive management should immediately and comprehensively assess your company’s global manufacturing operations to ensure that your systems, processes, and products conform to FDA requirements.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.If you are considering an action that is likely to lead to a disruption in the supply of drugs produced at your facility, FDA requests that you contact CDER’s Drug Shortages Staff immediately, at drugshortages@fda.hhs.gov, so that FDA can work with you on the most effective way to bring your operations into compliance with the law. Contacting the Drug Shortages Staff also allows you to meet any obligations you may have to report discontinuances or interruptions in your drug manufacture under 21 U.S.C. 356C(b). This also allows FDA to consider, as soon as possible, what actions, if any, may be needed to avoid shortages and protect the health of patients who depend on your products.Correct any violations promptly. 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 any violations.Failure to address any violations may also result in the FDA refusing admission of articles manufactured at Jubilant HollisterStier General Partnership at 16751 Trans-Canada Highway, Kirkland, into the United States under section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3). Articles under this authority that appear to be adulterated may be detained or refused admission, in that the methods and controls used in their manufacture do not appear to conform to CGMP within the meaning of section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. 351(a)(2)(B).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 days1. 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 3001623073 and ATTN: Erika V. Butler.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and Research____________________1 Under program enhancements for the Generic Drug User Fee Amendments (GDUFA) reauthorization for fiscal years (FYs) 2023-2027, also known as the GDUFA III Commitment Letter, your facility may be eligible for a Post-Warning Letter Meeting to obtain preliminary feedback from FDA on the adequacy and completeness of your corrective action plans.
行政执法案件信息公开表(2026年第4期,总第190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自然人名称违法企业组织机构代码证/ 统一社会信用代码法定代表人/负责人姓名主要违法事实行政处罚内容决定机关名称处罚决定日期公示日期备注1渝药监处罚〔2025〕51号重庆青岚堂药业有限公司(原重庆香溪堂药业有限公司)未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案重庆青岚堂药业有限公司(原重庆香溪堂药业有限公司)91500108MA7EFB821N 伍光国当事人未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阿卡波糖片。当事人的行为违反了《中华人民共和国药品管理法》第五十五条的规定。依据《中华人民共和国药品管理法》第一百二十九条的规定,责令当事人改正违法行为,并决定给予行政处罚如下:1.没收违法购进药品阿卡波糖片1080盒;2罚款400000.00元。重庆市药品监督管理局2026/06/222026/06/24
今年以来,朔州市市场监管局持续深化药品安全专项整治,强化与公安机关的行刑衔接联动机制,重拳打击各类涉药违法犯罪行为。3月至6月期间,累计查办并依法移送公安机关涉嫌药品刑事犯罪案件10起,实现涉药违法犯罪全链条闭环打击,有效净化药品市场环境。专项整治行动中,朔州市局聚焦美容美发、纹绣、私人诊所等重点场所,针对无资质经营、非法渠道购进药品、使用未经批准进口药品、医美类注射剂违规经营等突出风险开展精准排查,深挖隐蔽性违法线索。同时,与公安机关建立“线索共享、联合研判、快速移送、闭环处置”协同执法模式,对排查发现的涉嫌刑事犯罪案件,第一时间固定完整证据链,依法依规移送公安机关立案侦查,坚决杜绝以罚代刑,实现行政处罚与刑事追责无缝衔接。此次移送的10起案件均涉嫌妨害药品管理罪,每一起案件均形成完整合规的证据链。截至目前,涉药违法案件已全部完成移送,通过严查重处形成强大执法震慑,有效遏制非法使用未经批准药品的违法乱象,消除了一批药品安全风险隐患,进一步规范了药品采购、储存、经营、使用秩序。朔州市局将始终保持药品安全监管高压态势,持续深化与公安部门的常态化联合执法,紧盯药品、医美、医疗器械等重点领域,常态化开展隐患排查和专项整治,严厉打击各类涉药违法犯罪行为。同时强化普法宣传与行业引导,督促各类经营主体严格落实药品安全主体责任,切实守护群众用药安全底线。(崔英杰 于志鹏)
重庆市南川区东城街道社区卫生服务中心行政处罚决定书文号:南川医保处罚字﹝2026﹞第5号违法行为类型:依据《医疗保障基金使用监督管理条例》第二十条违法事实:冒名购药、虚假购药处罚依据:《医疗保障基金使用监督管理条例》第四十条处罚类别:罚款处罚内容:一、责令退回居民医保基金支付金额1120.78元,职工医保基金支付金额2443.56元;二、处罚款。罚款金额(万元):0.712866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:2026-06-16处罚机关:重庆市南川区医疗保障局数据来源单位:重庆市南川区医疗保障局数据来源单位代码:11500384MB193805X5信息更新时间:2026-06-22
重庆市万州区白羊镇中心卫生院(重庆市万州区白羊镇计划生育服务站)行政处罚决定书文号:万州医保处罚医保处罚字﹝2026﹞第000003号违法行为类型:医疗保障基金使用监督管理条例第三十八条第三项,医疗保障基金使用监督管理条例第三十八条第二项,医疗保障基金使用监督管理条例第三十八条第六项,医疗保障基金使用监督管理条例第三十八条第七项违法事实:重庆市万州区白羊镇中心卫生院涉嫌定点医药机构存在违反诊疗规范过度诊疗、过度检查、分解处方、超量开药、重复开药或者提供其他不必要的医药服务行为的处罚等4项违法行为案处罚依据:医疗保障基金使用监督管理条例第三十八条第三项,医疗保障基金使用监督管理条例第三十八条;医疗保障基金使用监督管理条例第三十八条第二项,医疗保障基金使用监督管理条例第三十八条第六项;医疗保障基金使用监督管理条例第三十八条,医疗保障基金使用监督管理条例第三十八条;医疗保障基金使用监督管理条例第三十八条第七项处罚类别:罚款处罚内容:1、处以罚款人民币壹拾万玖仟零壹拾肆元陆角柒分(¥109,014.67)。罚款金额(万元):10.901500没收违法所得、没收非法财物的金额(万元):0.000000暂扣或吊销证照名称及编号:处罚决定日期:2026-06-15处罚机关:重庆市万州区医疗保障局数据来源单位:重庆市万州区医疗保障局数据来源单位代码:11500101MB16468747信息更新时间:2026-06-22