行政相对人名称 新疆清腾畅医疗器械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 91654024MABLYDL350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 张小龙行政处罚决定书文号 伊巩市监处罚〔2026〕88号违法行为类型 药械化妆品违法行为违法事实 新疆清腾畅医疗器械有限公司经营过期的一次性使用灭菌橡胶外科手套二类医疗器械。处罚依据 法律处罚类别 没收非法财物;罚款处罚内容 依据《医疗器械监督管理条例》第八十六条“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：（三）经营、使用无合格证明文件、过期、失效、淘汰的医疗器械，或者使用未依法注册的医疗器械”的规定，决定给予该公司以下行政处罚：1、没收该批过期的医疗器械；2、罚款2000.00元。罚款金额（万元） 0.2没收违法所得没收非法财物的金额（万元） 0暂扣或吊销证照名称及编号 处罚决定日期 2026/06/08处罚有效期 2099/12/31公示截止期 2026/09/08处罚机关 巩留县市场监督管理局处罚机关统一社会信用代码 11654124MB1469687D数据来源单位 新疆维吾尔自治区市场监督管理局数据来源单位统一社会信用代码 126500004576118054处罚附带惩戒期限（月） 备注

行政相对人名称 新疆汇泰药品销售有限公司巴里坤泽宇店行政相对人类别 法人及非法人组织统一社会信用代码 91650521MAD68FR45N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 陈立洁行政处罚决定书文号 哈巴市监处罚〔2026〕28号违法行为类型 药械化妆品违法行为违法事实 经调查，1.当事人的经营方式是零售连锁门店，具备远程审方的资质；2.当事人承认在2026年3月26日已收到因未经依法经过资质认定的药师或药学技术人员在岗审核销售处方药的行为收到巴里坤哈萨克自治县市场监督管理局责令改正通知书（哈巴市监责改[2026]45号）；3.新疆汇泰药品销售有限公司巴里坤泽宇店的考勤是通过钉钉打卡记录的，现场检查发现的3份处方药销售票均是在该店工作时间段：10：00至20：00内，执业药师张小云不在岗时销售的；4.该店执业药师张小云在2026年4月2日因家中有事不在岗，执业药师当天在新疆汇泰药品销售有限公司巴里坤泽宇店的考勤打卡记录均无法提供。该店上述行为违反《药品经营和使用质量监督管理办法》第四十二条第五款“药品零售企业营业时间内，依法经过资格认定的药师或者其他药学技术人员不在岗时，应当挂牌告知。未经依法经过资格认定的药师或者其他药 学技术人员审核，不得销售处方药。”的规定，构成药品零售企业未经依法经过资格认定的药师或者其他药学技术人员审核销售处方药的行为。处罚依据 法律处罚类别 罚款处罚内容 1.罚款人民币3000元整；罚款金额（万元） 0.3没收违法所得没收非法财物的金额（万元） 0暂扣或吊销证照名称及编号 处罚决定日期 2026/06/08处罚有效期 2099/12/31公示截止期 2026/09/08处罚机关 巴里坤哈萨克自治县市场监督管理局处罚机关统一社会信用代码 11652222MB0N838636数据来源单位 新疆维吾尔自治区市场监督管理局数据来源单位统一社会信用代码 126500004576118054处罚附带惩戒期限（月） 备注

行政相对人名称 伊犁康之源药业连锁有限责任公司巩留县第五十七分店行政相对人类别 法人及非法人组织统一社会信用代码 91654024MA7970WMX5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 铁常治行政处罚决定书文号 伊巩市监处罚〔2026〕87号违法行为类型 药械化妆品违法行为违法事实 伊犁康之源药业连锁有限责任公司巩留县第五十七分店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再林阿莫西林颗粒，违反了《中华人民共和国药品管理法》第五十五条“药品上市许可持有人、药品生产企业、药品经营企业和医疗机构应当从药品上市许可持有人或者具有药品生产、经营资格的企业购进药品;但是，购进未实施审批管理的中药材除外。”的规定。处罚依据 中华人民共和国药品管理法处罚类别 没收违法所得;没收非法财物;罚款处罚内容 依据《中华人民共和国药品管理法》第一百二十九条“违反本法规定，药品上市许可持有人、药品生产企业、药品经营企业或者医疗机构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的，责令改正，没收违法购进的药品和违法所得，并处违法购进药品货值金额二倍以上十倍以下的罚款;情节严重的，并处货值金额十倍以上三十倍以下的罚款，吊销药品批准证明文件、药品生产许可证、药品经营许可证或者医疗机构执业许可证;货值金额不足五万元的，按五万元计算。”的规定，决定给予以下行政处罚：1.没收该批违法购进的药品；2.没收违法所得42元；3.罚款2000.00元。罚没款合计2042元。罚款金额（万元） 0.2没收违法所得没收非法财物的金额（万元） 0.0042暂扣或吊销证照名称及编号 处罚决定日期 2026/06/08处罚有效期 2099/12/31公示截止期 2026/09/08处罚机关 巩留县市场监督管理局处罚机关统一社会信用代码 11654124MB1469687D数据来源单位 新疆维吾尔自治区市场监督管理局数据来源单位统一社会信用代码 126500004576118054处罚附带惩戒期限（月） 备注

　　当事人名称：义乌市加岑贸易有限公司　　统一社会信用代码：91330782MAEXCLT939　　法定代表人：邹云龙　　地址：浙江省金华市义乌市稠江街道龙回四区38幢5单元303　　2026年3月18日，义乌市加岑贸易有限公司向海关申报出口一批护发用品、护肤用品、洗发水等货物（报关单号：292020260000106843）。经查验，该批货物中有：“Karseell”商标的护发素1435瓶，价值人民币10045元；“KERASTASE”商标的护发素955瓶，价值人民币6685元；“NIVEA”商标的润肤乳2155个，价值人民币17240元；“REXONA”商标的止汗露3590瓶，价值人民币17950元；“VASELINE”商标的润唇膏2875个，价值人民币14375元；“VEET”商标的脱毛膏4310个，价值人民币21550元。以上货物共价值人民币87845元。经联系，广州程熙化妆品有限公司、莱雅公司、拜尔斯道夫股份有限公司、联合利华知识产权控股私人有限公司、瑞基特·戈尔曼（海外）健康有限公司认为上述货物属于侵犯其“Karseell、KERASTASE、NIVEA、REXONA、VASELINE、VEET”（海关备案号：T2026-214701、T2021-108384、T2020-101202、T2023-147021、T2022-125001、T2021-106128）商标权的商品，并向海关提出采取知识产权保护措施的申请。　　我关经调查，认为当事人出口的护发素、润肤乳、止汗露、润唇膏、脱毛膏上使用的“Karseell、KERASTASE、NIVEA、REXONA、VASELINE、VEET”商标，与商标权人注册的商标相同，且事先未经商标权人许可。依照《中华人民共和国商标法》第五十七条第一项的规定，上述货物属于侵犯他人商标权的货物，当事人的行为已构成出口侵犯他人商标权货物的行为。　　案件办理过程中，当事人配合海关查处出口侵权货物违法行为且认错认罚，具有从轻处罚情节。　　以上事实有海关出口货物报关单证、海关查验记录、权利人权利证明、扣留凭单、当事人陈述、认错认罚声明、工商资料等材料为证。　　依照《中华人民共和国海关行政处罚实施条例》第二十五条第一款之规定，并按照《中华人民共和国海关行政处罚裁量基准（三）》（海关总署公告2023年第198号发布）第十一条第二项、第十三条第二项裁量，决定没收当事人侵权货物（“Karseell”商标的护发素1435瓶、“KERASTASE”商标的护发素955瓶、“NIVEA”商标的润肤乳2155个、“REXONA”商标的止汗露3590瓶、“VASELINE”商标的润唇膏2875个、“VEET”商标的脱毛膏4310个），并处罚款人民币4400元。　　依照《中华人民共和国行政处罚法》第六十六条、第六十七条、第六十九条的规定，当事人应当自本处罚决定书送达之日起十五日内履行上述处罚决定。　　当事人不服本处罚决定的，依照《中华人民共和国行政复议法》第二十条、第二十七条，《中华人民共和国行政诉讼法》第四十六条之规定，可自本处罚决定书送达之日起六十日内向宁波海关申请行政复议，或者自本处罚决定书送达之日起六个月内，直接向宁波市中级人民法院起诉。　　依照《中华人民共和国行政处罚法》第七十二条之规定，到期不缴纳罚款的，每日可以按罚款数额的百分之三加处罚款。　　依照《中华人民共和国海关法》第九十三条、《中华人民共和国海关行政处罚实施条例》第六十条的规定，当事人逾期不履行处罚决定又不申请复议或者向人民法院提起诉讼的，海关可以将扣留的货物、物品、运输工具依法变价抵缴，或者以当事人提供的担保抵缴；也可以申请人民法院强制执行。　　二○二六年六月五日

当事人：义乌市融源进出口有限公司，统一社会信用代码：91330782MA2M20HD6N，海关编码：3318960DRN，单位性质：民营企业，单位地址：浙江省义乌市稠城街道赋城小区四幢1单元4楼401（自主申报），法定代表人：蒋承栋。经我关调查，当事人有以下违法行为：2025年9月4日至2026年1月29日期间，当事人以跨境电商网购保税进口申报清单形式向海关申报了2448项商品，商品名称包括TOOFACED化妆品工具包L、TOOFACED化妆品工具包蜜桃、TOOFACED眼影等货物共计成交总价为179694.89元。当事人未如实分别申报清单内各项商品价格,造成少缴纳消费税和增值税。以上涉案货物计税总价为179694.89元人民币，应纳税款共计38903.88元人民币，漏缴税款共计13298.77元人民币。当事人价格申报不实的行为影响国家税款征收。以上行为有：1、授权委托书；2、查问笔录；3、企业营业执照复印件；4、跨境电商单一窗口截图；5、涉案商品信息汇总；6、询问笔录；7、企业情况说明；8、税款核定证明书；9、行政处罚记录查询结果等证据为证。当事人价格申报不实影响国家税款征收的行为违反了《中华人民共和国海关法》第二十四条第一款之规定，构成《中华人民共和国海关法》第八十六条第三项、《中华人民共和国海关行政处罚实施条例》第十五条第四项所列之违反海关监管规定的行为。依据《中华人民共和国海关行政处罚实施条例》第十五条第四项、《中华人民共和国海关行政处罚裁量基准（一）》（总署公告2023第182号）第十四条第三项之规定，决定对当事人作出如下行政处罚：科处罚款人民币1万元整。当事人应当自收到本决定书之日起十五日内，依照《中华人民共和国行政处罚法》第六十六条、第六十七条之规定，到农业银行义乌福田支行缴纳罚款。当事人不服本处罚决定的，依照《中华人民共和国行政复议法》第二十条、第二十七条、《中华人民共和国行政诉讼法》第四十六条之规定，可自收到本决定书之日起六十日内杭州海关申请行政复议，或者自收到本决定书之日起六个月内，直接向金华市中级人民法院提起诉讼。依照《中华人民共和国行政处罚法》第七十二条、《中华人民共和国海关法》第九十三条之规定，当事人到期不缴纳罚款的，每日可以按罚款数额的百分之三加处罚款，加处罚款的数额不超出罚款数额；当事人逾期不履行处罚决定又不申请复议或者向人民法院提起诉讼的，海关可以将扣留的货物、物品、运输工具依法变价抵缴，或者以当事人提供的保证金抵缴；也可以采取法律规定的其他行政强制执行方式或者申请人民法院强制执行。（关印）2026年06月10日

奥林巴斯贸易（上海）有限公司报告，由于涉及产品前面板“黑屏”等问题，奥林巴斯贸易（上海）有限公司对其生产的气腹机高速気腹装置（注册证号：国械注进20172061144）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2026年06月10日

西门子医疗系统有限公司报告，因西门子医疗发现用于固定显示器的部分螺丝可能随着使用时间增加逐渐松动，可能造成支撑臂内布设的电缆损坏，继而可能导致显示器无法显示图像。在极端情况下，可能导致显示器托架与支撑臂分离并掉落。西门子医疗系统有限公司对其生产的医用血管造影X射线机（注册证号：国械注进20233060603）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2026年06月10日

西门子医学诊断产品（上海）有限公司报告，糖化血红蛋白测定试剂盒（蛋白酶法）（A1c_E）在Atellica CH全自动生化分析仪上检测时，存在偶发性孔间偏差的潜在可能，可能导致糖化血红蛋白结果假性偏低或偏高。美国西门子医学诊断股份有限公司Siemens Healthcare Diagnostics Inc.对其生产的糖化血红蛋白测定试剂盒（蛋白酶法）（注册证编号：国械注进20212400126)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2026年06月10日

宁夏药品监督管理局行政处罚案件信息公示行政处罚决定书文号宁药监药罚〔2026〕1号案件名称宁夏德林医药有限公司购进销售假药案违法行为类型购进销售假药案件类型一般违法行为违法企业名称宁夏德林医药有限公司被处罚人统一社会信用代码91640122715019434W法定代表人姓名汪 海主要违法事实当事人因购进销售假药阿托伐他汀钙片（批号：8168876、规格：20mg*28片），违反了《中华人民共和国药品管理法》第九十八条第一款的规定，构成销售假药违法行为。处罚种类和方式给予没收其销售假药的违法所得15876元的行政处罚。行政处罚依据   《中华人民共和国药品管理法》第一百一十六条、《中华人民共和国药品管理法实施条例》（2019年修订版）第七十五条的规定。行政处罚的履行方式和期限自收到决定书之日起十五日内主动履行作出处罚的机关名称宁夏回族自治区药品监督管理局作出处罚的决定日期2026年5月20日

Delivery Method:VIA UPSReference #:320-26-93Product:DrugsRecipient:Dr. Hailin ChenGeneral ManagerHubei Gedian Humanwell Pharmaceutical Co., Ltd.No. 25 Juxian RoadGedian Economic Development DistrictEzhou Shi Hubei Sheng, 436070Chinachenhalin@renfu.com.cnIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter 320-26-93June 3, 2026Dear Dr. Chen:The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Hubei Gedian Humanwell Pharmaceutical Co., Ltd., FEI 3004117486, located at No. 25 Juxian Road, Gedian Economic Development District, Ezhou City, Hubei Province, China, from November 3 to 7, 2025.This warning letter summarizes significant deviations from Current Good Manufacturing Practice (CGMP) for active pharmaceutical ingredients (APIs).Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your APIs 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 28, 2025 response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence.During our inspection, our investigator observed specific deviations including, but not limited to, the following.1. Failure to clean equipment and utensils to prevent contamination or carry-over of a material that would alter the quality of the API beyond the official or other established specifications.Your firm manufactures (b)(4) for the U.S. market. During the inspection, our investigator observed numerous scratches and (b)(4) stains on the interior API-contact surfaces of your (b)(4) vessels, as well as (b)(4) markings on the lid and rim of the (b)(4) of your (b)(4) vessel. These markings and discolored stains indicate that the integrity of the API-contact surfaces is being compromised which can lead to contamination of your API with particulate matter (e.g., (b)(4) particles) or alter the quality of the API via chemical leachable reactions.In your response, you state that compatibility between the equipment product contact surface material of construction and the chemical process, specifically the (b)(4) and the (b)(4) process, is insufficient. You state that the (b)(4) chemicals used in the process weakens the (b)(4) on the (b)(4) surfaces which leads to (b)(4) manifested as (b)(4) stains/discoloration and scratches. You (b)(4) your (b)(4) and (b)(4) the interior walls and plan to perform preventive (b)(4) maintenance (b)(4). You (b)(4) the (b)(4) markings on the (b)(4) and lid and replaced the (b)(4) gasket sealing the (b)(4) lid.Your response is inadequate because you do not support the frequency of your preventive (b)(4) maintenance schedule with scientific rationale based on your processes’ chemistry. Your response also did not evaluate the reactivity of all interior surfaces of the equipment train with your (b)(4) process. Furthermore, you rationalized that the risk to product quality risk is low based on results of release testing using a qualified method.Your equipment materials of construction are inadequate because your product-contact surfaces may alter the quality of the product in that they were additive, absorptive, or reactive. Inadequately maintained manufacturing equipment can lead to potential contamination that could compromise the quality and safety of your APIs.In response to this letter, provide:Your corrective action and preventive action (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.A retrospective, independent review of all batches within expiry that could have been affected by scratches and discoloration within the (b)(4) vessels introduced as a result of your manufacturing process, including an evaluation of retain samples for elements within your (b)(4) and/or impurities. Include a review of customer complaints for the last three years.A review of all your manufacturing processes to determine whether there is reactivity with all respective product-contact surfaces in your equipment.An evaluation of your process and equipment to determine whether changes will be implemented to remove the risk of foreign material introduced to APIs due to process design and inadequate product contact materials of construction. Include a list of all product contact surfaces exposed to varying chemical reactions in your facility, and supporting information regarding (b)(4) resistance against typical conditions in the vessels. Also include a plan, including timeline, for changing product contact surfaces to appropriate (b)(4) materials of construction given the inherent nature of the chemical processes utilized.2. Failure of your quality unit to exercise its responsibility to ensure the API manufactured at your facility are in compliance with CGMP.Your quality unit (QU) was not exercising its basic responsibilities for oversight of the manufacture of your APIs. For example, your QU failed to ensure the following:Buildings and facilities used in the manufacture of APIs have been properly maintained (e.g., no gaps around windows and doors).You did not evaluate the compatibility between the equipment product contact surface material of construction and the chemical processes used in the manufacture of APIs to ensure suitability for its intended use.In your response, you state that you revised the job responsibilities of the QU to increase the spot check frequency and to inspect the production floor equipment conditions. Your response is inadequate because the revised QU inspection duties checklist includes determining whether the equipment is “under normal working conditions.” This statement is vague and does not specify or provide appropriate guidance to identify discoloration, scratches, markings, and production room structural issues.Significant 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.In response to this letter, provide:An assessment of each drug product process to ensure suitability of equipment for its intended use and sufficiency of detectability in your monitoring and testing systems.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 appropriateo Provisions for QU oversight throughout your operations to evaluate adherence to appropriate practicesAPI CGMP GuidanceFDA considers the expectations outlined in International Conference on Harmonization (ICH) Q7 when determining whether APIs and intermediates are manufactured in conformance with CGMP. See FDA’s guidance document Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients for guidance regarding CGMP for the manufacture of APIs at https://www.fda.gov/media/71518/download.ConclusionThe deviations cited in this letter are not intended to be an all-inclusive list of deviations that exist at your facility. You are responsible for investigating and determining the causes of any deviations and for preventing their recurrence or the occurrence of other deviations.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 deviations promptly. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any deviations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to any deviations.Failure to address any deviations may also result in the FDA refusing admission of articles manufactured at Hubei Gedian Humanwell Pharmaceutical Co., Ltd., FEI 3004117486, located at No. 25 Juxian Road, Gedian Economic Development District, Ezhou City, Hubei Province, 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 deviations 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 3004117486 and ATTN: Barbara Wilimczyk-Macri.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and ResearchCc: Registered U.S. AgentRegistrar CorpEmail: drugs@registrarcorp.com_______________________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.