迈柯唯（上海）医疗设备有限公司报告，生产企业在原《沪药监械主召2025-163》的召回行动基础上，增加了两项额外措施，即对设备的水循环报警值进行检查和重新校准压力传感器，从而保证低压报警被触发，避免加热元件在运行过程中过热，引起烟雾或起火情况的发生。本着对客户负责，确保产品使用安全、有效，生产企业对其生产的清洗消毒器（注册证编号：国食药监械(进)字2012第2570864号、国械注进20152573837）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05月20日

为切实筑牢辖区药品流通领域安全防线，杜绝监管缺位，深刻汲取近期各类安全生产事故教训，省药监局酒泉执法检查局紧扣省局今年药品流通环节监督检查工作部署，聚焦药品批发企业、零售连锁总部核心监管对象，常态化开展日常监督检查，以严监管、实举措护航辖区药品安全形势持续稳定向好。提高政治站位，压实安全责任。组织全体干部学习习近平总书记关于安全生产的重要论述和指示批示精神，深入剖析事故背后企业主体责任缺失、安全管理形同虚设、监管执法宽松软等深层次问题，以案为鉴、以案明纪，进一步强化“安全无小事、责任大于天”的底线思维。结合辖区药品流通监管实际，明确检查目标、重点内容与工作要求，将安全生产理念贯穿药品流通监管全过程，督促企业严格落实药品安全主体责任，健全安全管理制度，完善风险防控机制，坚决防范各类药品安全事故发生。聚焦重点环节，精准排查隐患。严格遵循《中华人民共和国药品管理法》、GSP等法律法规，重点核查企业药品购销渠道合法性、入库验收、出库复核、储存温湿度控制、特殊药品管理、超范围经营、药品追溯体系运行等关键环节，严查票账货不符等违法违规行为；同时，重点检查企业质量管理体系文件、安全应急预案制定及员工安全培训落实情况。检查过程中，执法人员始终秉持“严、细、实”工作作风，对发现的轻微隐患现场指导企业立行立改，对存在的问题建立台账、限期整改、跟踪督办，形成“排查—整改—复核—闭环”全流程监管机制，坚决杜绝“屡查屡犯、隐患放任”问题。下一步，省药监局酒泉执法检查局将持续深化常态化监管，以事故案例为警示，不断强化监管力度、细化监管举措，压实企业主体责任与部门监管责任，全力防范化解药品流通领域各类风险，切实保障人民群众用药安全、有效。

九江市中医医院向我局提交了注销《医疗机构制剂许可证》的申请。按照《中华人民共和国行政许可法》《药品生产监督管理办法》等有关规定，同意注销九江市中医医院的《医疗机构制剂许可证》。自注销之日起，九江市中医医院停止从事医疗机构制剂配制活动。单位名称注册地址配制地址配制范围许可证编号注销原因九江市中医医院九江市庐山南路261号九江市庐山南路261号颗粒剂、丸剂赣20160005Z主动申请注销特此公告。江西省药品监督管理局2026年5月19日 （公开属性：主动公开）

根据企业申请，依据《药品经营和使用质量监督管理办法》第二十七条的规定，我局依法注销湖南正贤堂大药房连锁有限公司的《药品经营许可证》。自公告注销之日起，上述企业不得从事任何形式的药品经营活动。附件：注销《药品经营许可证》的企业名单湖南省药品监督管理局2026年5月18日   （公开属性：主动公开）

　　5月14日，福建省药监局召开化妆品监管工作交流会。省局化妆品监管处、省药品审评中心、省药品核查中心相关负责同志，省日化商会、省特殊食品和化妆品协会负责人，以及6家重点化妆品企业代表参会。　　会议重点介绍了《福建省药品监督管理局关于支持化妆品产业高质量发展若干措施（征求意见稿）》的起草思路和总体考虑，针对前期行业协会和企业提出的意见建议进行探讨交流，并对《福建省化妆品企业生产质量管理体系提升三年行动计划（2026—2028年）实施方案》的重点任务进行了解读。各行业协会、商会围绕闽妆品牌培育推广、团体标准制定、出海合规服务等方面提出工作打算和相关建议，与会企业介绍了自身生产质量管理体系运行情况。　　会上，省局监管人员从行业合规发展、优化监管服务等方面，对企业遇到的产品和新原料注册备案、质量体系提升改进等难点问题给予具体的指导。　　下一步，省局将结合产业发展实际，进一步优化相关监管措施，强化政策指导帮扶和行业合规指引，全力服务产业高质量发展。

企业名称阜新东藏药业有限责任公司企业类型药品批发企业检查时间2026年4月27日-2026年4月30日所在地市阜新市检查依据《药品管理法》《药品经营质量管理规范》等法律、法规。 检查事项药品经营检查 检查方式常规检查 检查内容执行GSP情况存在问题在人员与培训方面存在2026年度培训内容不完整的问题。处理措施立即整改整改情况已按要求完成整改

Delivery Method:Via Electronic Mail - Return Receipt RequestedReference #:728782Product:DrugsRecipient:La Crema De Rebeca5508 Apple Orchard LaneAustin, TX 78744United Stateslacremaderebeca@gmail.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesMay 14, 2026WARNING LETTERTo La Crema De Rebeca:This warning letter advises you of significant violations observed during a U.S. Food and Drug Administration (FDA) review of your website. Promptly address the violations described herein without delay, including ensuring that appropriate resources are allocated to fully address the violations and prevent their recurrence. This is not intended to be an all-inclusive list of the violations that may exist in connection with your products or operations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. Failure to adequately address violations may result in regulatory or legal action without further notice including, without limitation, seizure and injunction.FDA has observed that you offer products marketed on your firm's website as skin treatment and skin lightening products, including, but not limited to, “La Crema De Rebeca” for sale in the United States. Additionally, FDA obtained a sample of “La Crema de Rebeca” and has serious safety concerns about this product. FDA confirmed through laboratory analysis that “La Crema de Rebeca” contains high levels of mercury. Applying products that contain mercury to the skin repeatedly can allow mercury to be absorbed into the bloodstream, potentially causing serious and permanent health problems, including kidney damage and neurological damage. Children and pregnant individuals face heightened risks and should avoid exposure to these products.FDA ReviewViolations were identified and documented during a review of your website https://lacremaderebeca.com/ in April 2026. Based on our review, your product is an unapproved new drug and a misbranded drug under sections 505(a) and 502(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a) and 352(a). As explained further below, introducing or delivering these products for introduction into interstate commerce violates sections 301(a), 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(a), 331(d) and 355(a).This review was conducted under FDA’s public health responsibilities to protect the public from unsafe, ineffective, and poor-quality drugs.Violations of the Federal Food, Drug, and Cosmetic ActUnapproved New Drug ViolationsThe following are violations identified during our review. As a reminder, this is not an all-inclusive list of violations that may exist in connection with your products or operations.Based on a review of your website, “La Crema De Rebeca” is a drug under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure or any function of the body. Examples from your product labeling, including on your website, that provide evidence of the intended use (as defined in 21 CFR 201.128) of this product as a drug include, but may not be limited to, the following:On the product webpage https://lacremaderebeca.com/shop%2Ftienda/ols/products/crema:“This cream helps remove Acne, Dark spots, Freckles, Rosacea, Moles.”“It's the best way to reduce blemishes, acne, melasma, freckles, redness, moles, fine lines, pimples, and other imperfections.”“Eliminates acne, freckles, melasma, blackheads, and all types of skin imperfections.”“Fades sunspots. Lightens underarms.”“Acne disappears, freckles, dark spots, black spots and all kinds of skin imperfections.”Your product is a "new drug" under section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because it is not generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended, or suggested in its labeling. With certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, 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, 21 U.S.C. 355, are in effect for this product. Accordingly, this product is an unapproved new drug. The introduction or delivery for introduction into interstate commerce of this unapproved new drug product violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).Misbranded Drug Violations"La Crema De Rebeca" is misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a). Under section 502(a) of the FD&C Act, 21 U.S.C. 352(a), a drug is misbranded if its labeling is false or misleading in any particular. Section 201(n) of the FD&C Act, 21 U.S.C. 321(n), provides that, in determining whether an article's labeling or advertising "is misleading there shall be taken into account . . . not only representations made or suggested . . . but also the extent to which the labeling or advertising fails to reveal facts material in light of such representations."The labeling for "La Crema De Rebeca" does not declare that it contains mercury. As previously mentioned, FDA confirmed through laboratory analysis that "La Crema De Rebeca" contains high levels of mercury. Consumers may purchase and use this product without knowing that it contains mercury, an ingredient that may cause serious harm, including kidney damage and neurological damage. The failure to disclose mercury in the product labeling renders "La Crema De Rebeca" misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a).The introduction or delivery for introduction into interstate commerce of this misbranded drug product is a prohibited act under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).ConclusionAs previously stated, you are responsible for investigating and determining the root causes of any violations and implementing corrective and preventative measures to ensure future compliance so that these violations and any others do not occur.Send your written response to FDAAdvisory@fda.hhs.gov within fifteen (15) business days of receipt of this letter. Include the specific steps you have taken to correct any violations, an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. Identify your written response with reference number “728782” in the subject line of the email.If you have information that you believe demonstrates that your products are not in violation of the FD&C Act and FDA regulations, include that information for our consideration.Please note FDA posts warning letters on www.fda.gov.Sincerely,/S/Tina Smith, M.S.Captain, U.S. Public Health ServiceDirectorOffice of Unapproved Drugs and Labeling ComplianceOffice of ComplianceCenter for Drug Evaluation and ResearchU.S. Food and Drug Administration

Delivery Method:Via Electronic Mail - Return Receipt RequestedReference #:728783Product:DrugsRecipient:Lus Essentials LLC605 Ravoux RoadChaska, MN 55318United Statesningdeleon482@gmail.cominfo@lusessentials.storeIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesMay 14, 2026WARNING LETTERTo Lu’s Essentials:This warning letter advises you of significant violations observed during a U.S. Food and Drug Administration (FDA) review of your website. Promptly address the violations described herein without delay, including ensuring that appropriate resources are allocated to fully address the violations and prevent their recurrence. This is not intended to be an all-inclusive list of the violations that may exist in connection with your products or operations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. Failure to adequately address violations may result in regulatory or legal action without further notice including, without limitation, seizure and injunction.FDA has observed that you offer products marketed on your firm’s website as skin treatment and skin lightening products, including, but not limited to, “Dr. Yanhee Acne Treatment Set (Green)” and “Dr. Yanhee Cream Set (Pekas & Melasma Treatment) – Blue” (hereinafter “your products”) for sale in the United States. Additionally, FDA obtained a sample of these products and has serious safety concerns about them. FDA confirmed through laboratory analysis that these products contain high levels of mercury. Applying products that contain mercury to the skin repeatedly can allow mercury to be absorbed into the bloodstream, potentially causing serious and permanent health problems, including kidney damage and neurological damage. Children and pregnant individuals face heightened risks and should avoid exposure to these products.FDA ReviewViolations were identified and documented during a review of your website https://lusessentials.store in April 2026. Based on our review, your products are unapproved new drugs and misbranded drugs under sections 505(a) and 502(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a) and 352(a). As explained further below, introducing or delivering these products for introduction into interstate commerce violates sections 301(a), 301(d), and 505(a) of the FD&C Act, 21 U.S.C. 331(a), 331(d), and 355(a).This review was conducted under FDA’s public health responsibilities to protect the public from unsafe, ineffective, and poor-quality drugs.Violations of the Federal Food, Drug, and Cosmetic ActUnapproved New Drug ViolationsThe following are violations identified during our review. As a reminder, this is not an allinclusive list of violations that may exist in connection with your products or operations.Based on a review of your website, your products are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure or any function of the body. Examples from your product labeling, including on your website, that provide evidence of the intended use (as defined in 21 CFR 201.128) of these products as drugs include, but may not be limited to, the following:Dr. Yanhee Acne Treatment Set (Green)On the webpage https://lusessentials.store/products/dr-yanhee-acne-treatment-setgreen?variant=45027938828483:“Reduce acne, freckles, dark spots and tighten pores.”“Benefits: [t]reatment for [p]imples and [s]ever [sic] acne problems, [d]ark spots, reduce visible scars.”“Protects skin from the sun and skin whitening.”Dr. Yanhee Cream Set (Pekas & Melasma Treatment) - BlueOn the webpage https://lusessentials.store/products/dr-yanhee-whitening-cream-set-reduceacne-dark-spot-freckles-result-in-7-day?variant=44387523657923:“Dr.Yanhee [sic] Whitening Cream Set Reduce Acne Dark Spot Freckles Result in 7 day original Formula.”“Helps to eliminate dead cells, tighten pores, reduce acne, freckles, dark spots, dark circles, make your face bounce.”“Doctor YanHee Set (Blue Box) Original Formula is a popular face cream to help treat acne, freckles, good grade, original formula.”Your products are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended, or suggested in their labeling. With certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, 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, 21 U.S.C. 355, are in effect for these products. Accordingly, these products are unapproved new drugs. The introduction or delivery for introduction into interstate commerce of these unapproved new drug products violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).Misbranded Drug ViolationsYour products are misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a). Under section 502(a) of the FD&C Act, 21 U.S.C. 352(a), a drug is misbranded if its labeling is false or misleading in any particular. Section 201(n) of the FD&C Act, 21 U.S.C. 321(n), provides that, in determining whether an article's labeling or advertising "is misleading there shall be taken into account . . . not only representations made or suggested . . . but also the extent to which the labeling or advertising fails to reveal facts material in light of such representations."The labeling for your products does not declare that they contain mercury. As previously mentioned, FDA confirmed through laboratory analysis that your products contain high levels of mercury. Consumers may purchase and use these products without knowing that they contain mercury, an ingredient that may cause serious harm, including kidney damage and neurological damage. The failure to disclose mercury in the product labeling renders your products misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a).The introduction or delivery for introduction into interstate commerce of these misbranded drug products is a prohibited act under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).ConclusionAs previously stated, you are responsible for investigating and determining the root causes of any violations and implementing corrective and preventative measures to ensure future compliance so that these violations and any others do not occur.Send your written response to FDAAdvisory@fda.hhs.gov within fifteen (15) business days of receipt of this letter. Include the specific steps you have taken to correct any violations, an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. Identify your written response with reference number “728783” in the subject line of the email.If you have information that you believe demonstrates that your products are not in violation of the FD&C Act and FDA regulations, include that information for our consideration.Please note FDA posts warning letters on www.fda.gov.Sincerely,/S/Tina Smith, M.S.Captain, U.S. Public Health ServiceDirectorOffice of Unapproved Drugs and Labeling ComplianceOffice of ComplianceCenter for Drug Evaluation and ResearchU.S. Food and Drug Administration