行政处罚决定书文号沪药监稽处〔2026〕762025000045号案件名称上海铂诗玥医疗美容诊所有限公司使用过期医疗器械、未依照条例规定建立并执行医疗器械进货查验记录制度案违法行为类型经营、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;医疗器械经营企业、使用单位未依照本条例规定建立并执行医疗器械进货查验记录制度违法企业名称或违法自然人姓名上海铂诗玥医疗美容诊所有限公司被处罚人的统一社会信用代码（组织机构代码）91310105MA1FW4GK3N法定代表人姓名赵卉主要违法事实2023年6月29日，当事人从上海容然医疗器械贸易有限公司购进20支注射用交联透明质酸钠凝胶（国械注进20203130165，品牌：乔雅登-缇颜，批号：1000501442，有效期至2024年1月17日）和20支注射用交联透明质酸钠凝胶（国械注进20153131708，品牌：乔雅登-极致，批号：1000520297，有效期至2024年3月16日）。其中，16支注射用交联透明质酸钠凝胶（国械注进20203130165，品牌：乔雅登-缇颜，批号：1000501442）和19支注射用交联透明质酸钠凝胶（国械注进20153131708，品牌：乔雅登-极致，批号：1000520297）均在有效期内被使用完毕。 2024年3月21日、4月19日、6月22日，当事人分别将4支上述注射用交联透明质酸钠凝胶（国械注进20203130165，品牌：乔雅登-缇颜，批号：1000501442，有效期至2024年1月17日）产品提供给顾客使用；2024年5月20日，当事人将1支上述注射用交联透明质酸钠凝胶（国械注进20153131708，品牌：乔雅登-极致，批号：1000520297，有效期至2024年3月16日）产品提供给顾客使用。当事人将上述5支注射用交联透明质酸钠凝胶提供给顾客使用时均已过期。 上述5支过期的注射用交联透明质酸钠凝胶的货值金额为人民币以元。 另查，2024年当事人制定了《医疗器械采购、验收管理制度》。2023年1月至2025年3月，当事人购进整形用胶原和PMMA皮下植入物系统（注册证编号：国械注进20163132859）、含利多卡因注射用交联透明质酸钠凝胶（国械注进20213130485）等医疗器械时，未记录医疗器械名称、生产批号、供货商地址及联系方式，未完整记录医疗器械的使用期限或失效日期、注册人名称、供货者名称、相关许可证明文件编号。当事人未执行医疗器械进货查验记录制度。处罚种类和方式警告,罚款(220291.28元)行政处罚依据《医疗器械监督管理条例》第八十六条第(三)项，;《医疗器械监督管理条例》第八十九条第(三)项，行政处罚的履行方式和期限当事人应当自收到本行政处罚决定书之日起十五日内，携带本行政处罚决定书，将罚款缴至本市工商银行或者建设银行的具体代收机构。到期不缴纳罚款的，本局依据《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。作出处罚的机关名称（全称）上海市药品监督管理局作出处罚的决定日期2026年03月04日

2025年，化妆品监管处立足产业特质，坚持监管与服务并重，努力实现安全底线与发展高线协同推进。一、培育“新成分”，激活产业创新的“美丽因子”产业要升级，原料需先行。通过55家次生产检查筑牢安全基础，更着力当好创新“辅导员”。全年提供技术帮扶40人次，助力10家企业快速获证准入，高效完成备案审核2380个。成功指导企业备案金花茶花、金花茶叶、白玉兰3个国家化妆品新原料，实现广西化妆品产业新原料创新发展“零”突破，让本土资源转化为产业竞争力，为“桂妆”贴上独有标签。二、锻造“侦察仪”，提升风险防控的“靶向精度”面对品类繁多、流通快速的化妆品市场，强化抽检的“雷达”作用。国抽检出不合格率6.91%，靶向率居全国前列。国家化妆品安全风险监测成绩优异，问题检出率11%获得中检院肯定。作为全国开展化妆品快检运用五个试点省份之一，以南宁、河池为试点开展两期国家化妆品快检联合执法工作，排查382家化妆品经营场所，现场发现问题样品389批次，现场立案61起，实现了对潜在风险的快速识别与打击。组织自治区药检院在拓展性检验和探索性研究中发现4处质量安全风险问题，提出5项化妆品标准制修订建议，为化妆品标准的制定完善和科学监管等提供依据。广西局连续三年获评为国家化妆品抽样检验工作、国家化妆品安全风险监测与评价工作表现突出单位。三、织密“监测网”，构建不良反应预警的“前哨体系”安全感知贵在灵敏。全力打通监测“毛细血管”，开展化妆品不良反应监测账号注册率提升行动，全年新增254家，较上年提高13倍。推广应用广西化妆品不良反应上报管理系统，强化医疗机构报告主渠道作用，报告信息与医疗机构信息系统、国家相关信息系统无缝衔接，全面服务区、市、基层三级监测机构。针对化妆品网络销售新业态，实施专项监测27.7万次，抓取违法线索152条，其中立案7起、责令改正28条。充分发挥监测与监管执法协同机制，查办3起严重不良反应案件，形成安全监管闭环，柳州美度染发膏和桂林完美谜题化妆品案例入选国家局化妆品不良反应监测案例。广西药监局连续两年获评为国家化妆品不良反应监测工作表现突出单位。化妆品监管，守护的是人民群众“容颜上的安全”。未来，将继续聚焦产业特点，精准施策，以更智慧的监管、更贴心的服务，助力广西“美丽经济”生机勃勃，行稳致远。供稿：化妆品监管处

Delivery Method:VIA ELECTRONIC MAIL READ/DELIVERY RECEIPT REQUESTEDProduct:DrugsRecipient:Refills Health, LLC dba Refills Health1401 Pennsylvania Ave, Suite 105Wilmington,DE19806United Statessupport@refills.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERFebruary 20, 2026Refills Health:This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website content at the internet address https://www.refills.com, in December 2025, and has observed that your website offers compounded drug products, including semaglutide drug products.1As described below, your website’s false or misleading claims concerning compounded semaglutide products under sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act (FDCA) [21 U.S.C. §§ 352(a) and 352(bb)], result in products being introduced or delivered for introduction into interstate commerce in violation of section 301(a) of the FDCA [21 U.S.C. § 331(a)].Under section 502(a) of the FDCA [21 U.S.C. § 352(a)] a drug is misbranded if its labeling is false or misleading in any particular. Furthermore, under section 502(bb) of the FDCA [21 U.S.C. § 352(bb)], a compounded drug is misbranded if its advertising or promotion is false or misleading in any particular.The compounded semaglutide products displayed on your website identify “Refills Health” on the pictured label, suggesting Refills Health is the compounder of those drugs when in fact it is not.2Accordingly, the representations on your website that Refills Health is the compounder of these drug products are false or misleading, and the products are therefore misbranded under sections 502(a) and 502(bb) of the FDCA [21 U.S.C. §§ 352(a) and (bb)].Additionally, the following claims concerning compounded semaglutide products appear on your website:“clinically proven”“the same active ingredient found in certain FDA approved treatments”Compounded drug products are not FDA-approved. Your claims imply that your products have been FDA-approved or otherwise evaluated for safety and effectiveness when they have not. As a result, these claims are false or misleading and your products are therefore misbranded under sections 502(a) and 502(bb) of the FDCA [21 U.S.C. §§ 352(a) and (bb)].The introduction or delivery for introduction into interstate commerce of these misbranded products is a prohibited act under section 301(a) of the FDCA [21 U.S.C. § 331(a)]. The representations and claims identified in this letter put you on notice of our concerns but do not represent an exhaustive list of violations.For the reasons discussed above, your compounded semaglutide products are misbranded drugs under sections 502(a) and 502(bb) of the FDCA [21 U.S.C. §§ 352(a) and 352(bb)], introduced or delivered for introduction into interstate commerce in violation of section 301(a) of the FDCA [21 U.S.C. § 331(a)]. Please be advised, the receipt in interstate commerce of misbranded drugs, and the delivery or proffered delivery thereof, is also a violation of section 301(c) of the FDCA [21 U.S.C. § 331(c)].As previously stated, the violations cited in this letter are not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your operations comply with all requirements of federal law, including FDA regulations. For example, compounded drug products must meet the conditions in sections 503A or 503B of the FD&C Act [21 U.S.C. §§ 353a or 353b] in order to be exempt from certain requirements under the Act, including the new drug approval requirements.You should take immediate action to address any violations. Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.Within fifteen (15) working days of receipt of this letter, please provide a written response to the Office of Compounding Quality and Compliance (OCQC) within the Center for Drug Evaluation and Research (CDER)’s Office of Compliance describing the specific steps you have taken to address any violations. Please include an explanation of each step being taken to prevent the recurrence of any violations, as well as copies of related documentation. Such steps may include:1) Identifying the entities that produce the compounded products offered on your website;2) Providing a representative sample of labeling for such products; and3) Addressing the basis for other website claims that could be construed as false or misleading or demonstrating that such claims have been modified or removed in light of FDCA §§ 502(a) and 502(bb)) [21 U.S.C. §§ 352(a) and (bb)].This letter notifies you of our concerns and provides you an opportunity to address them. In your written response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices. If you cannot completely address this matter within fifteen (15) working days, state the reason for the delay and the time within which you will do so.If you are not located in the U.S., please note that products that appear to be misbranded 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 misbranded products that cannot be legally sold to consumers in the U.S.All correspondence should include a subject line that clearly identifies the submission as a Response to Warning Letter. If you have questions regarding the contents of this letter, please contact compoundinginspections@fda.hhs.gov.Sincerely,/S/Matthew J. LashActing DirectorOffice of Compounding Quality and ComplianceOffice of ComplianceCenter for Drug Evaluation and Research___________________1The semaglutide products offered on your website are drugs within the meaning of section 201(g) of the FDCA [21 U.S.C. § 321(g)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases and/or because they are intended to affect the structure or any function of the body. Further, they are “new drugs” within the meaning of section 201(p) of the FDCA [21 U.S.C. § 321(p)] because they are not generally recognized as safe and effective for their labeled uses.2See also 21 CFR § 201.1(h)(2) (“The appearance on a drug product label of a person’s name without qualification is a representation that the named person is the sole manufacturer of the product. That representation is false and misleading, and the drug product is misbranded under section 502(a) of the act, if the person is not the manufacturer of the product in accordance with this section.”); FDCA §503(b) [21 § U.S.C. 353(b)], FDCA §503B(a)(10)(A)(ii) [21 U.S.C. § 353b(a)(10)(A)(ii)]. We note that 21 CFR § 201.1(a) does not apply to drug products dispensed in accordance with section 503(b)(1) of the FDCA [21 USC § 353(b)(1)]. However, see 45 Fed. Reg. 25760, 25765 (Apr. 15, 1980) (“…if the label of a prescription drug product dispensed by a pharmacist does contain a representation as to the manufacturer, packer, or distributor, it must comply with all the provisions of § 201.1…”). In addition, the labels of your drug products as depicted on the website do not indicate that they are dispensed under section 503(b)(1) of the FDCA [21 USC § 353(b)(1)], nor do they appear to comply with the requirements of section 503(b)(2) [21 USC § 353(b)(2)].

　　为深入落实医疗器械“春雨行动”部署，精准对接企业需求、破解发展瓶颈，开年后，市药监局第五分局主动下沉服务重心，走进中关村顺义园开展“送服务、解难题、促发展”专题调研，以靠前服务为区域医疗器械产业注入发展动能。　　精准培育，激活创新活力。第五分局与园区企业、重点实验室、科研单位面对面座谈，细致宣讲医疗器械最新法规及“春雨行动”惠企举措，确保政策直达快享；同步摸排企业研发及成果转化诉求，筛选3项重点转化项目，提供全链条跟踪帮扶，推动科研成果落地转化。　　融监管于服务，破解发展堵点。打破传统监管模式，搭建政企高效沟通桥梁，通过提前介入、现场指导、靶向帮扶，帮助企业厘清合规思路、规范生产流程，切实解决产品注册、质量管控等实际难题，坚定企业创新发展信心。　　跨部门联动，凝聚发展合力。依托园区管委会，主动对接卫健、经信、科委等部门，建立协同服务机制，整合各类优势资源，构建“研发—转化—上市—应用”全链条服务体系，打通服务企业“最后一公里”。　　下一步，第五分局将持续深化“春雨行动”成效，常态化开展精准送服务活动，优化举措、提升效能，助力园区医疗器械企业提质增效、创新突破，推动区域产业高质量发展。

2025年10月，我局对大连天山药业有限公司硬胶囊剂生产进行了GMP符合性检查，经现场检查和综合评定，依据《药品生产监督管理办法》第五十九条第三款的规定，决定同意大连天山药业有限公司自通告发布之日起，恢复硬胶囊剂生产。 特此通告。 辽宁省药品监督管理局2026年3月4日

各相关药品生产、经营企业：    根据海南省医疗保障局《海南省医药采购平台药品挂网交易采购规则》等文件相关要求，为进一步规范挂网药品信息，统一中成药和生物类似药日均治疗费用计算方式，现将完善中成药和生物类似药挂网信息要求通知如下：    一、自通知之日起，新申报挂网的中成药和生物类似药，相关生产、经营企业通过常态化挂网界面，上传药品说明书，严格按照药品说明书填写用法用量，无需填报日均治疗费。    二、中成药和生物类似药生产、经营企业对已挂网全量药品，需补充上传药品说明书，严格按照药品说明书填写用法用量。    请已挂网药品生产、经营企业于2026年3月12日前，登录海南医保服务平台医药招采子系统（https://ybj.hainan.gov.cn/hallEnter/#/Index），进入“药品招标管理-药品挂网管理-用法用量维护”上传相关药品说明书和填写用法用量信息。    三、其它要求：上传药品说明书请使用JPEG/JPG/PNG格式；企业如有异议，联系电话：0898-66529803。                                                                  海南省公共资源交易服务中心                                                                         2026年3月4日

　经监督检查，东莞市康源药业有限公司的综合评定结论为不符合要求，存在药品质量安全隐患。根据《中华人民共和国药品管理法》第九十九条及《药品检查管理办法（试行）》第六十一条规定，广东省药品监督管理局对东莞市康源药业有限公司采取暂停销售风险控制措施，现予以公布。序号企业名称药品经营许可证编号综合评定结论风险控制措施1东莞市康源药业有限公司粤AA769000655不符合要求暂停销售　　企业应当严格落实主体责任，按照检查处理结果要求暂停销售，排除质量安全隐患后，向广东省药品监督管理局提交整改报告，经复查符合条件后予以解除风险控制措施。　　特此通告。广东省药品监督管理局2026年3月4日

　按照《医疗器械监督管理条例》《医疗器械生产监督管理办法》有关规定，根据企业申请，广东省药品监督管理局依法注销深圳市景创科技电子股份有限公司等12家企业的《医疗器械生产许可证》。　　特此通告。　　附件：企业信息广东省药品监督管理局2026年3月3日　　附件企业信息序号企业名称许可证编号生产地址1深圳市景创科技电子股份有限公司粤药监械生产许20224862号广东省深圳市宝安区燕罗街道罗田社区广田路58号厂房（3栋2楼）2珠海辉钰医疗科技有限公司粤食药监械生产许20142583号珠海市唐家湾镇大学路99号3号厂房D栋三层，珠海市唐家湾镇大学路99号12号楼3深圳柏斯生物科技有限公司粤食药监械生产许20162910号深圳市南山区西丽办事处松白路1051号百旺创意工厂6栋1014中康长和健康科技（深圳）有限公司粤食药监械生产许20214406号深圳市龙岗区宝龙街道宝龙社区宝荷大道76号智慧家园B座4025意迈事牙科（深圳）有限公司粤食药监械生产许20214323号深圳市宝安区石岩街道石龙社区工业二路1号惠科工业园厂房6栋6楼西面6深圳市美铭科技有限公司粤药监械生产许20235123号深圳市龙岗区坪地街道坪东社区同心路5号厂房2047深圳市束雅科技有限公司粤食药监械生产许20214589号深圳市南山区西丽街道阳光社区新锋一路荣城科研小镇3栋1028声海电子（深圳）有限公司粤药监械生产许20235262号广东省深圳市宝安区松岗街道燕川惠明盈工业园18栋二楼9中山骏诚医疗科技有限公司粤食药监械生产许20214429号中山市东升镇镇南路安兆街6号10美尚（广州）医疗科技有限公司粤食药监械生产许20172987号广州市白云区嘉禾街罗岗七星岗路98号一栋301房11深圳市丰之健电子科技有限公司粤食药监械生产许20224623号深圳市宝安区沙井街道后亭社区大埔北路佳领域工贸大厦902、90312广州泽润康医疗科技有限公司粤药监械生产许20255666号广州市白云区白云湖街大朗朗环路新风街1号二楼

　　依据《中华人民共和国行政许可法》第七十条、《执业药师注册管理办法》第二十四条的规定，现依法注销黄崇贵等8人的《执业药师注册证》，并予以公告。                               　　　　　　　　　　　　　　　　　　　　　　　　　　 重庆市药品监督管理局                                   　　　　　　　　　　　　　　　　　　　　　　　　　2026年2月24日附件 注销的注册证内容序号姓名执业单位《执业药师注册证》编号1黄崇贵重庆市生养大药房5022251302092杨文全重庆万灵大药房5022251302223刘国华重庆市巴南区兴新药房5012211300974吴春莉重庆市巴南区唐智学药房5012241304535杨柳重庆市巴南区康之源药房5012201304946郝苗重庆何科药房5022231300457王坤健重庆坤健大药房5022251304338胡国斌重庆市巴南区霖之大康药房502225130437

通用电气医疗系统贸易发展（上海）有限公司报告，GE医疗近期发现，部分版本的Centricity Universal Viewer存在潜在网络安全漏洞。用户登录凭据可能会在本地客户端工作站上泄露，这可能导致未授权人员影响系统可用性，和/或对数据进行篡改。该隐患仅在以下条件下触发——用户使用 Microsoft Edge 浏览器，且所在机构未配置通过企业网络账户（如活动目录/轻型目录访问协议 (LDAP)）完成用户身份验证。通用电气医疗系统贸易发展（上海）有限公司对其生产的影像归档及传输软件（注册证号：国械注进20182701756、国械注进20182211756）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03月04日