为加强药品质量监管，保障公众用药安全，2025年，省药监局组织各市药品监管部门开展了药品监督抽检工作。经检验，发现2批次药品（见附件）不符合规定，相关药品监管部门已依法进行了调查处置。依据《药品质量抽查检验管理办法》第五十二条的规定，现将相关信息予以公开。  特此通告。  辽宁省药品监督管理局  2025年11月5日

按照《医疗器械监督管理条例》的规定，根据企业申请，国家药品监督管理局现注销以下8家企业共10个产品的医疗器械注册证：　　一、 施乐辉外科植入物（北京）有限公司的2个产品：膝关节系统，注册证编号：国械注准20183130489；骨水泥柄，注册证编号：国械注准20193130586。　　二、 奥林巴斯医疗株式会社的1个产品：一次性内镜用注射针，注册证编号：国械注进20173146975。　　三、 美国施乐辉有限公司Smith & Nephew, Inc.的1个产品：迷你万向锁定接骨板系统EVOS Mini-Fragment Plating System,注册证编号：国械注进20213130368。　　四、 鹰眼（香河）内窥镜科技有限公司的1个产品：输尿管内窥镜，注册证编号：国械注准20223060660。　　五、 深圳市鹏瑞智能图像有限公司的1个产品：一次性使用电子上消化道内窥镜，注册证编号：国械注准20213060913。　　六、 美国雅培公司 Abbott Laboratories的1个产品：血液分析仪Hematology Analyzer，注册证编号：国械注进20162224756。　　七、 普惠医工股份有限公司的2个产品：血液净化装置的体外循环血路，注册证编号：国械注进20163100077；内瘘管翼状针A-V FISTULA NEEDLE SET，注册证编号：国械注许20153100147。　　八、 江西青山堂医疗器械有限公司的1个产品：一次性使用自损毁型无菌注射器，注册证编号：国械注准20163140821。　　特此公告。　国家药监局2025年11月3日

根据《广东省食品药品监督管理局关于〈药品经营许可证〉注销的管理规定》（粤食药监法〔2013〕26号），我局已依法注销肇庆市大家好药房有限公司鼎湖区东怡市场分店等1间企业的《药品经营许可证》，现予以公布。序号许可证号许可证有效期限企业名称注销时间注销原因1粤DB7580001862028年12月12日肇庆市大家好药房有限公司鼎湖区东怡市场分店2025年11月06日企业申请肇庆市鼎湖区市场监督管理局2025年11月06日

根据《中华人民共和国行政许可法》《中华人民共和国药品管理法》《药品经营和使用质量监督管理办法》等规定，现决定依法注销江西良生医药有限公司、江西天琢药业有限公司的《药品经营许可证》（详见附件）。特此公告。附件：注销药品经营许可证企业名单 江西省药品监督管理局 2025年11月6日附件注销药品经营许可证企业名单序号企业名称法定代表人许可证编号注册地址注销原因1江西良生医药有限公司高童赣AA7950463江西省宜春市袁州区医药工业园湖东路90号主动申请注销2江西天琢药业有限公司张鹏赣AA797000352江西省赣州市于都县上欧工业园里仁路886号主动申请注销

医保基金是守护群众健康的“救命钱”，其安全运行直接关系广大参保群众切身利益。当前，部分参保人利用门诊特殊疾病待遇、虚构用药需求、跨机构超量购药等手段，甚至勾结“药贩子”、医护人员形成团伙，将医保药品变为牟利工具，严重侵蚀基金安全、破坏医保秩序。为以案释法、以案警示，引导参保人自觉守法，督促医疗机构规范诊疗服务，推动形成全社会共同守护医保基金安全的良好氛围，国家医保局发布第三期5起个人骗取医保基金典型案例。案例一云南省丽江市参保人罗某违规超量购药并倒卖骗取医保基金案云南省丽江市医保部门根据相关线索开展专项核查时，发现丽江市宁蒗县参保人罗某存在超量购药的异常行为，遂开展深入调查。经查，2021年3月至2023年8月期间，罗某利用自身享受器官移植特殊病种医保待遇，超合理治疗需求开具药品并倒卖牟利，累计造成医保基金损失219.9万元。在核查固定相关证据后，宁蒗县医保局将案件线索移送公安机关立案侦查。2025年3月，人民法院依法作出判决：罗某犯诈骗罪，判处有期徒刑3年，并处罚金人民币10000元；同时责令其全额退赔医保基金。案例二重庆市渝中区宋某甲和宋某乙违规超量购药并倒卖骗取医保基金案重庆市医保局接到群众举报，反映渝中区参保人宋某甲长期在多家机构超量购药，涉嫌倒卖医保药品骗取医保基金。渝中区医保局立即联合区公安局开展深入调查。经查，2023年1月以来，宋某甲利用本人及兄长宋某乙的门诊特殊疾病医保待遇，在全市30余家医疗机构超量购买门诊特殊疾病药品并转卖“药贩子”牟利，共造成医保基金损失62.73万元。循此线索，公安机关于2025年3月成功抓获“药贩子”潘某某，查获涉案药品500余种，货值约80万元。目前，犯罪嫌疑人宋某甲、潘某某因涉嫌犯诈骗罪已移送检察机关审查起诉。依据《医疗保障基金使用监督管理条例》，渝中区医保局已暂停犯罪嫌疑人医疗费用结算。案例三四川省眉山市参保人张某违规超量购药并倒卖骗取医保基金案四川省眉山市医保部门通过大数据筛查发现，参保人张某存在明显超量购药异常行为。当地医保部门随即联合公安机关开展调查。经查，张某分别在成都市、眉山市等地的多家医疗机构购药数百次，购药数量远超同期实际用药上限。循此线索，眉山市公安机关联合医保部门运用药品追溯码追踪药品流通轨迹，成功打掉一个长期盘踞在成都市、眉山市等地专门收售门诊特殊疾病药品的特大犯罪团伙，抓获犯罪嫌疑人18人，现场扣押违法资金60余万元、医保药品5万余盒。目前，案件已由眉山市检察机关向审判机关提起公诉。眉山市医保部门已对违规超量开药的人员和机构作出行政处罚，挽回医保基金26.97万元，并对8名违规超量开药的医生予以记分处理，对负主要责任的医生暂停医保支付资格2个月，并将相关线索移交纪检监察机关。案例四 浙江省乐清市参保人许某某违规超量购药并倒卖骗取医保基金案浙江省乐清市医保部门根据大数据筛查发现，参保人许某某存在频繁跨医院挂号并超量开具他克莫司胶囊等高价药品的异常行为，随即会同公安机关开展联合查办。经查，许某某利用享受特殊疾病医保待遇便利，2016年以来通过虚构用药需求在多家医院频繁开药，随后将多开的药品以较低价格转卖他人，共造成医保基金损失17万余元。2025年7月，乐清市人民法院以诈骗罪判处许某某有期徒刑3年，缓刑3年6个月，并处罚金人民币1.5万元，责令许某某退赔赃款17万余元，所有违法所得均予以没收。案例五江西省赣州市刘某某等4名参保人违规超量购药并倒卖骗取医保基金案近期，江西省赣州市医保部门通过大数据筛查发现，参保人刘某某存在频繁超量购买双通道药品“泊沙康唑肠溶片”的异常行为。当地医保部门立即组织力量开展现场检查。经查，刘某某以“长期外出需要带药”为由，多次通过微信联系赣州市某医院医生杜某超量开具药品处方，并由医药公司业务员凭处方到药店购药后，通过快递邮寄给刘某某。刘某某则将购得的超量药品分4次转卖，造成医保基金损失超2万元，非法获利7000余元。延伸检查发现，该院医生杜某、钟某共为包括刘某某在内的4名参保人超量开具“泊沙康唑肠溶片”60余盒，涉及药品金额13.6万余元。目前，赣州市医保部门已责令刘某某等4名参保人退回违规使用医保基金12.9万元，当地公安机关已对上述4名参保人采取刑事强制措施。杜某、钟某2名医生涉嫌超量开药线索已移送纪检监察机关。案件还在进一步办理中，医保部门还将对2名医生进行医保支付资格记分管理。本期5起个人骗保案例集中暴露违规超量购药倒卖、利用特殊病种骗保等问题，部分案件涉及医护违规、“药贩子”参与，造成基金重大损失。医保部门联合司法机关对相关违法违规人员进行了严肃处理，对骗保人员依法刑事处罚、追赃挽损，对违规医护记分、暂停支付资格，彰显对骗保“零容忍”态度。守护医保基金安全，需要各方协同发力。参保人应珍惜医保待遇，杜绝骗保念头；医疗机构要严格规范诊疗和处方行为，守住基金安全底线；医保部门将持续强化监管手段，畅通举报渠道，织密基金监管“防护网”。唯有全社会共同参与、共同监督，才能确保医保基金用在刀刃上，切实保障全体参保人的医保权益。

Product:DrugsRecipient:MeamoSouth KoreaIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesUnited StatesWARNING LETTERNovember 3, 2025Meamo:This is to advise you that the United States (U.S.) Food and Drug Administration (FDA) recently reviewed your website at the Internet address www.meamoshop.com and has observed that your website introduces into interstate commerce misbranded and unapproved new drugs in violation of sections 301(a), 301(d), 503(b), and 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. §§ 331(a), 331(d), 353(b), and 355(a)]. As discussed below, FDA has observed that www.meamoshop.com introduces into interstate commerce unapproved and misbranded injectable botulinum toxin drug products.There are inherent risks to consumers who purchase unapproved new drugs and misbranded drugs. Unapproved new drugs do not carry the same assurances of safety and effectiveness as those drugs subject to FDA oversight. Drugs that have circumvented regulatory safeguards may be contaminated, counterfeit, contain varying amounts of active ingredients, or contain different ingredients altogether. Furthermore, injectable drug products can pose a serious risk of harm to users because they bypass many of the body’s natural defenses against toxic ingredients, toxins, or dangerous organisms that can lead to serious and life-threatening conditions such as septicemia or sepsis. Accordingly, FDA requests that www.meamoshop.com cease offering any unapproved and misbranded drugs for sale to U.S. consumers. This is critical to shielding the American public from harm.Unapproved New Drugs:Certain products offered for sale by www.meamoshop.com are drugs within the meaning of section 201(g) of the FD&C Act [21 U.S.C. § 321(g)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or because they are intended to affect the structure or function of the body. These drugs are also new drugs as defined by section 201(p) of the FD&C Act [21 U.S.C. § 321(p)], because they are not generally recognized as safe and effective for their labeled uses. With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, 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 are in effect for these products. Accordingly, their introduction or delivery for introduction into interstate commerce violates sections 301(d) [21 U.S.C. § 331(d)] and 505(a) of the FD&C Act.An example of an unapproved botulinum toxin drug product you offer for sale on www.meamoshop.com is botulinum toxin type A marketed as “X4 Wondertox 100U Set” and “Wondertox”. Evidence obtained from your website establishing that this product is a drug intended for human use (as defined in 21 CFR 201.128) includes the claim “Treatment of benign essential blepharspasm in adult patients.”While there are FDA-approved versions of botulinum toxin drug products on the market in the U.S., there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for “X4 Wondertox 100U Set” and “Wondertox” offered by www.meamoshop.com. Currently there are several botulinum toxin products FDA-approved for the U.S. market and these products are only available pursuant to a prescription from a licensed practitioner. Examples of FDA-approved botulinum toxin products with a summary of their indications are: BOTOX® (onabotulinumtoxinA), indicated for the treatment of overactive bladder, neurogenic detrusor overactivity, chronic migraine, spasticity, cervical dystonia, severe primary axillary hyperhidrosis, strabismus, and blepharospasm and prophylaxis of headaches in adults with chronic migraines; DAXXIFY® (daxibotulinumtoxinA-lanm), indicated for the temporary improvement in the appearance of glabellar lines and the treatment of cervical dystonia; and MYOBLOC® (rimabotulinumtoxinB), indicated for the treatment of cervical dystonia and chronic sialorrhea.Furthermore, FDA-approved botulinum toxin drug products bear a boxed warning, commonly referred to as a “black box warning,” which is the strongest warning FDA requires, indicating that the drug carries a significant risk of serious or even life-threatening adverse effects. The boxed warning addresses the risk of distant spread of toxin effect to produce symptoms consistent with botulinum toxin effects. In addition, swallowing and breathing difficulties can be life threatening and there have been reports of death.Misbranded Drugs:A drug is misbranded under section 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)] if its labeling fails to bear adequate directions for use. “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (see 21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1) of the FD&C Act [21 U.S.C. § 353(b)(1)] include those that, because of their toxicity or other potentiality for harmful effect, and/or the method of their use, and/or the collateral measures necessary for their use, are not safe for use except under supervision of a practitioner licensed by law to administer them. Prescription drugs, as defined in section 503(b)(1)(A) of the FD&C Act, can be used safely only at the direction, and under the supervision, of a licensed practitioner.Because the aforementioned drug is a prescription drug intended for conditions that are not amenable to self-diagnosis and treatment by a layperson, adequate directions cannot be written such that a layperson can use the products safely for their intended use. Consequently, the labeling for these drug products fail to bear adequate directions for use, causing them to be misbranded under section 502(f)(1) of the FD&C Act. In addition, because these drugs are not approved in the U.S., they are also not exempt under 21 CFR 201.115(a) from the requirements of section 502(f)(1) of the FD&C Act. By offering these drugs for sale to U.S. consumers, www.meamoshop.com is causing the introduction of misbranded drugs into interstate commerce in violation of section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].FDA is sending this warning letter to www.meamoshop.com because of the inherent risks to consumers who purchase misbranded and unapproved new drugs. This letter is not intended to identify all the ways in which your products or operations might be in violation of the law. It is your responsibility to ensure that all products you offer for sale are in compliance with the FD&C Act and its implementing regulations. You should take prompt action to address any violations of the FD&C Act (which may include the offer for sale of similarly misbranded and/or unapproved new drugs other than the drug products noted above). We advise you to review your websites, product labels, and other labeling and promotional materials to ensure that you are not misleadingly representing your products as safe and effective for a use for which they have not been approved by FDA and that you are not distributing misbranded and unapproved drug products in violation of the FD&C Act.Please notify this office in writing within 15 working days describing the specific steps you have taken to address any violations and to prevent their recurrence. Include an explanation of each step being taken to remedy and prevent the recurrence of any violations, as well as copies of related documentation. Failure to adequately address this matter may result in legal action, including, without limitation, seizure, and injunction, without further notice. If you cannot complete corrective action within 15 working days, state the reason for the delay and the time within which you will complete the corrections. This letter notifies you of our concerns and provides you with an opportunity to address them. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration within 15 working days.If you are not located in the U.S., please note that products that appear to be misbranded or unapproved new drugs 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 unapproved and misbranded products that cannot be legally sold to consumers in the U.S.Please direct your response and any inquiries to FDA at FDAInternetPharmacyTaskForce-CDER@fda.hhs.gov.Sincerely,/s/__________________________________Sangeeta Vaswani Chatterjee, Pharm.D.Acting DirectorOffice of Drug Security, Integrity, and ResponseOffice of ComplianceCenter for Drug Evaluation and Research

Product:DrugsRecipient:MJS MedicalsSouth KoreaIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesUnited StatesWARNING LETTERNovember 3, 2025MJS Medicals:This is to advise you that the United States (U.S.) Food and Drug Administration (FDA) recently reviewed your website at the Internet address www.mjsmedicals.com and has observed that your website introduces into interstate commerce misbranded and unapproved new drugs in violation of sections 301(a), 301(d), 503(b), and 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. §§ 331(a), 331(d), 353(b), and 355(a)]. As discussed below, FDA has observed that www.mjsmedicals.com introduces into interstate commerce unapproved and misbranded injectable botulinum toxin drug products.There are inherent risks to consumers who purchase unapproved new drugs and misbranded drugs. Unapproved new drugs do not carry the same assurances of safety and effectiveness as those drugs subject to FDA oversight. Drugs that have circumvented regulatory safeguards may be contaminated, counterfeit, contain varying amounts of active ingredients, or contain different ingredients altogether. Furthermore, injectable drug products can pose a serious risk of harm to users because they bypass many of the body’s natural defenses against toxic ingredients, toxins, or dangerous organisms that can lead to serious and life-threatening conditions such as septicemia or sepsis. Accordingly, FDA requests that www.mjsmedicals.com cease offering any unapproved and misbranded drugs for sale to U.S. consumers. This is critical to shielding the American public from harm.Unapproved New Drugs:Certain products offered for sale by www.mjsmedicals.com are drugs within the meaning of section 201(g) of the FD&C Act [21 U.S.C. § 321(g)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or because they are intended to affect the structure or function of the body. These drugs are also new drugs as defined by section 201(p) of the FD&C Act [21 U.S.C. § 321(p)], because they are not generally recognized as safe and effective for their labeled uses. With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, 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 are in effect for these products. Accordingly, their introduction or delivery for introduction into interstate commerce violates sections 301(d) [21 U.S.C. § 331(d)] and 505(a) of the FD&C Act.An example of an unapproved botulinum toxin drug product you offer for sale on www.mjsmedicals.com is botulinum toxin type A marketed as “Innotox 100ui” and “Innotox 100u”. Evidence obtained from your website establishing that this product is a drug intended for human use (as defined in 21 CFR 201.128) includes the claims “Hyperhidrosis Control: 89% sweat reduction persisting 9.2 months (gravimetric analysis)” and “Neurological Disorders: 78% reduction in blepharospasm episodes (Jankovic Rating Scale)” under “Clinical Applications”.While there are FDA-approved versions of botulinum toxin drug products on the market in the U.S., there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for “Innotox 100ui” and “Innotox 100u” offered by www.mjsmedicals.com. Currently there are several botulinum toxin products FDA-approved for the U.S. market and these products are only available pursuant to a prescription from a licensed practitioner. Examples of FDA-approved botulinum toxin products with a summary of their indications are: BOTOX® (onabotulinumtoxinA), indicated for the treatment of overactive bladder, neurogenic detrusor overactivity, chronic migraine, spasticity, cervical dystonia, severe primary axillary hyperhidrosis, strabismus, and blepharospasm and prophylaxis of headaches in adults with chronic migraines; DAXXIFY® (daxibotulinumtoxinA-lanm), indicated for the temporary improvement in the appearance of glabellar lines and the treatment of cervical dystonia; and MYOBLOC® (rimabotulinumtoxinB), indicated for the treatment of cervical dystonia and chronic sialorrhea.Furthermore, FDA-approved botulinum toxin drug products bear a boxed warning, commonly referred to as a “black box warning,” which is the strongest warning FDA requires, indicating that the drug carries a significant risk of serious or even life-threatening adverse effects. The boxed warning addresses the risk of distant spread of toxin effect to produce symptoms consistent with botulinum toxin effects. In addition, swallowing and breathing difficulties can be life threatening and there have been reports of death.Misbranded Drugs:A drug is misbranded under section 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)] if its labeling fails to bear adequate directions for use. “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (see 21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1) of the FD&C Act [21 U.S.C. § 353(b)(1)] include those that, because of their toxicity or other potentiality for harmful effect, and/or the method of their use, and/or the collateral measures necessary for their use, are not safe for use except under supervision of a practitioner licensed by law to administer them. Prescription drugs, as defined in section 503(b)(1)(A) of the FD&C Act, can be used safely only at the direction, and under the supervision, of a licensed practitioner.Because the aforementioned drug is a prescription drug intended for conditions that are not amenable to self-diagnosis and treatment by a layperson, adequate directions cannot be written such that a layperson can use the products safely for their intended use. Consequently, the labeling for these drug products fail to bear adequate directions for use, causing them to be misbranded under section 502(f)(1) of the FD&C Act. In addition, because these drugs are not approved in the U.S., they are also not exempt under 21 CFR 201.115(a) from the requirements of section 502(f)(1) of the FD&C Act. By offering these drugs for sale to U.S. consumers, www.mjsmedicals.com is causing the introduction of misbranded drugs into interstate commerce in violation of section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].FDA is sending this warning letter to www.mjsmedicals.com because of the inherent risks to consumers who purchase misbranded and unapproved new drugs. This letter is not intended to identify all the ways in which your products or operations might be in violation of the law. It is your responsibility to ensure that all products you offer for sale are in compliance with the FD&C Act and its implementing regulations. You should take prompt action to address any violations of the FD&C Act (which may include the offer for sale of similarly misbranded and/or unapproved new drugs other than the drug products noted above). We advise you to review your websites, product labels, and other labeling and promotional materials to ensure that you are not misleadingly representing your products as safe and effective for a use for which they have not been approved by FDA and that you are not distributing misbranded and unapproved drug products in violation of the FD&C Act.Please notify this office in writing within 15 working days describing the specific steps you have taken to address any violations and to prevent their recurrence. Include an explanation of each step being taken to remedy and prevent the recurrence of any violations, as well as copies of related documentation. Failure to adequately address this matter may result in legal action, including, without limitation, seizure, and injunction, without further notice. If you cannot complete corrective action within 15 working days, state the reason for the delay and the time within which you will complete the corrections. This letter notifies you of our concerns and provides you with an opportunity to address them. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration within 15 working days.If you are not located in the U.S., please note that products that appear to be misbranded or unapproved new drugs 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 unapproved and misbranded products that cannot be legally sold to consumers in the U.S.Please direct your response and any inquiries to FDA at FDAInternetPharmacyTaskForce-CDER@fda.hhs.gov.Sincerely,/s/__________________________________Sangeeta Vaswani Chatterjee, Pharm.D.Acting DirectorOffice of Drug Security, Integrity, and ResponseOffice of ComplianceCenter for Drug Evaluation and Research

Product:DrugsRecipient:Derma SolutionUnited StatesIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesUnited StatesWARNING LETTERNovember 3, 2025Derma Solution:This is to advise you that the United States (U.S.) Food and Drug Administration (FDA) recently reviewed your website at the Internet address www.derma-solution.com and has observed that your website introduces into interstate commerce misbranded and unapproved new drugs in violation of sections 301(a), 301(d), 503(b), and 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. §§ 331(a), 331(d), 353(b), and 355(a)]. As discussed below, FDA has observed that www.derma-solution.com introduces into interstate commerce unapproved and misbranded injectable botulinum toxin drug products.There are inherent risks to consumers who purchase unapproved new drugs and misbranded drugs. Unapproved new drugs do not carry the same assurances of safety and effectiveness as those drugs subject to FDA oversight. Drugs that have circumvented regulatory safeguards may be contaminated, counterfeit, contain varying amounts of active ingredients, or contain different ingredients altogether. Furthermore, injectable drug products can pose a serious risk of harm to users because they bypass many of the body’s natural defenses against toxic ingredients, toxins, or dangerous organisms that can lead to serious and life-threatening conditions such as septicemia or sepsis. Accordingly, FDA requests that www.derma-solution.com cease offering any unapproved and misbranded drugs for sale to U.S. consumers. This is critical to shielding the American public from harm.Unapproved New Drugs:Certain products offered for sale by www.derma-solution.com are drugs within the meaning of section 201(g) of the FD&C Act [21 U.S.C. § 321(g)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or because they are intended to affect the structure or function of the body. These drugs are also new drugs as defined by section 201(p) of the FD&C Act [21 U.S.C. § 321(p)], because they are not generally recognized as safe and effective for their labeled uses. With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, 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 are in effect for these products. Accordingly, their introduction or delivery for introduction into interstate commerce violates sections 301(d) [21 U.S.C. § 331(d)] and 505(a) of the FD&C Act.An example of an unapproved botulinum toxin drug product you offer for sale on www.derma-solution.com is botulinum toxin type A marketed as “Botulax 300 Units” and “Botulax 300”. Evidence obtained from your website establishing that this product is a drug intended for human use (as defined in 21 CFR 201.128) includes the claims “This product helps treat conditions such as hyperhidrosis and blepharsopasm” and ”people suffering from migraines, excessive sweating, slow eye movements, and an overactive bladder can also benefit from this medication.”While there are FDA-approved versions of botulinum toxin drug products on the market in the U.S., there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for “Botulax 300 Units” and “Botulax 300” offered by www.derma-solution.com. Currently there are several botulinum toxin products FDA-approved for the U.S. market and these products are only available pursuant to a prescription from a licensed practitioner. Examples of FDA-approved botulinum toxin products with a summary of their indications are: BOTOX® (onabotulinumtoxinA), indicated for the treatment of overactive bladder, neurogenic detrusor overactivity, chronic migraine, spasticity, cervical dystonia, severe primary axillary hyperhidrosis, strabismus, and blepharospasm and prophylaxis of headaches in adults with chronic migraines; DAXXIFY® (daxibotulinumtoxinA-lanm), indicated for the temporary improvement in the appearance of glabellar lines and the treatment of cervical dystonia; and MYOBLOC® (rimabotulinumtoxinB), indicated for the treatment of cervical dystonia and chronic sialorrhea.Furthermore, FDA-approved botulinum toxin drug products bear a boxed warning, commonly referred to as a “black box warning,” which is the strongest warning FDA requires, indicating that the drug carries a significant risk of serious or even life-threatening adverse effects. The boxed warning addresses the risk of distant spread of toxin effect to produce symptoms consistent with botulinum toxin effects. In addition, swallowing and breathing difficulties can be life threatening and there have been reports of death.Misbranded Drugs:A drug is misbranded under section 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)] if its labeling fails to bear adequate directions for use. “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (see 21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1) of the FD&C Act [21 U.S.C. § 353(b)(1)] include those that, because of their toxicity or other potentiality for harmful effect, and/or the method of their use, and/or the collateral measures necessary for their use, are not safe for use except under supervision of a practitioner licensed by law to administer them. Prescription drugs, as defined in section 503(b)(1)(A) of the FD&C Act, can be used safely only at the direction, and under the supervision, of a licensed practitioner.Because the aforementioned drug is a prescription drug intended for conditions that are not amenable to self-diagnosis and treatment by a layperson, adequate directions cannot be written such that a layperson can use the products safely for their intended use. Consequently, the labeling for these drug products fail to bear adequate directions for use, causing them to be misbranded under section 502(f)(1) of the FD&C Act. In addition, because these drugs are not approved in the U.S., they are also not exempt under 21 CFR 201.115(a) from the requirements of section 502(f)(1) of the FD&C Act. By offering these drugs for sale to U.S. consumers, www.derma-solution.com is causing the introduction of misbranded drugs into interstate commerce in violation of section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].FDA is sending this warning letter to www.derma-solution.com because of the inherent risks to consumers who purchase misbranded and unapproved new drugs. This letter is not intended to identify all the ways in which your products or operations might be in violation of the law. It is your responsibility to ensure that all products you offer for sale are in compliance with the FD&C Act and its implementing regulations. You should take prompt action to address any violations of the FD&C Act (which may include the offer for sale of similarly misbranded and/or unapproved new drugs other than the drug products noted above). We advise you to review your websites, product labels, and other labeling and promotional materials to ensure that you are not misleadingly representing your products as safe and effective for a use for which they have not been approved by FDA and that you are not distributing misbranded and unapproved drug products in violation of the FD&C Act.Please notify this office in writing within 15 working days describing the specific steps you have taken to address any violations and to prevent their recurrence. Include an explanation of each step being taken to remedy and prevent the recurrence of any violations, as well as copies of related documentation. Failure to adequately address this matter may result in legal action, including, without limitation, seizure, and injunction, without further notice. If you cannot complete corrective action within 15 working days, state the reason for the delay and the time within which you will complete the corrections. This letter notifies you of our concerns and provides you with an opportunity to address them. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration within 15 working days.If you are not located in the U.S., please note that products that appear to be misbranded or unapproved new drugs 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 unapproved and misbranded products that cannot be legally sold to consumers in the U.S.Please direct your response and any inquiries to FDA at FDAInternetPharmacyTaskForce-CDER@fda.hhs.gov.Sincerely,/s/__________________________________Sangeeta Vaswani Chatterjee, Pharm.D.Acting DirectorOffice of Drug Security, Integrity, and ResponseOffice of ComplianceCenter for Drug Evaluation and Research

行政处罚案件信息摘要行政处罚决定书文号湘药监妆罚〔2025〕33号当事人长沙欣雨生物科技有限公司组织机构代码91430100MA4T6F4N80法定代表人梅字明违法类型长沙欣雨生物科技有限公司生产使用超过使用期限原料生产化妆品、未按照化妆品生产质量规范的要求组织生产案行政处罚内容1.没收违法所得758.2元，没收剩余违法半成品“焕颜素颜霜”等6桶102.92kg、“梵萃妍皙颜精华霜”等19个品规共1191瓶违法产品；2.共处15000元罚款，罚没款共计15758.2元。作出行政处罚决定的行政机关湖南省药品监督管理局作出行政处罚决定的日期2025年11月5日备注 相关附件： 相关阅读：

Product:DrugsRecipient:GlowfaceUnited StatesIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesUnited StatesWARNING LETTERNovember 3, 2025Glowface:This is to advise you that the United States (U.S.) Food and Drug Administration (FDA) recently reviewed your website at the Internet address www.glowface.store and has observed that your website introduces into interstate commerce misbranded and unapproved new drugs in violation of sections 301(a), 301(d), 503(b), and 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. §§ 331(a), 331(d), 353(b), and 355(a)]. As discussed below, FDA has observed that www.glowface.store introduces into interstate commerce unapproved and misbranded injectable botulinum toxin drug products.There are inherent risks to consumers who purchase unapproved new drugs and misbranded drugs. Unapproved new drugs do not carry the same assurances of safety and effectiveness as those drugs subject to FDA oversight. Drugs that have circumvented regulatory safeguards may be contaminated, counterfeit, contain varying amounts of active ingredients, or contain different ingredients altogether. Furthermore, injectable drug products can pose a serious risk of harm to users because they bypass many of the body’s natural defenses against toxic ingredients, toxins, or dangerous organisms that can lead to serious and life-threatening conditions such as septicemia or sepsis. Accordingly, FDA requests that www.glowface.store cease offering any unapproved and misbranded drugs for sale to U.S. consumers. This is critical to shielding the American public from harm.Unapproved New Drugs:Certain products offered for sale by www.glowface.store are drugs within the meaning of section 201(g) of the FD&C Act [21 U.S.C. § 321(g)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or because they are intended to affect the structure or function of the body. These drugs are also new drugs as defined by section 201(p) of the FD&C Act [21 U.S.C. § 321(p)], because they are not generally recognized as safe and effective for their labeled uses. With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, 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 are in effect for these products. Accordingly, their introduction or delivery for introduction into interstate commerce violates sections 301(d) [21 U.S.C. § 331(d)] and 505(a) of the FD&C Act.An example of an unapproved botulinum toxin drug product you offer for sale on www.glowface.store is botulinum toxin type A marketed as “Botulax 200U set” and “Botulax 200U”. Evidence obtained from your website establishing that this product is a drug intended for human use (as defined in 21 CFR 201.128) includes the claim “It is mainly used for improving mimic facial wrinkles, muscle spasm, hyperhidrosis and blepharospasm.”While there are FDA-approved versions of botulinum toxin drug products on the market in the U.S., there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for “Botulax 200U set” and “Botulax 200U” offered by www.glowface.store. Currently there are several botulinum toxin products FDA-approved for the U.S. market and these products are only available pursuant to a prescription from a licensed practitioner. Examples of FDA-approved botulinum toxin products with a summary of their indications are: BOTOX® (onabotulinumtoxinA), indicated for the treatment of overactive bladder, neurogenic detrusor overactivity, chronic migraine, spasticity, cervical dystonia, severe primary axillary hyperhidrosis, strabismus, and blepharospasm and prophylaxis of headaches in adults with chronic migraines; DAXXIFY® (daxibotulinumtoxinA-lanm), indicated for the temporary improvement in the appearance of glabellar lines and the treatment of cervical dystonia; and MYOBLOC® (rimabotulinumtoxinB), indicated for the treatment of cervical dystonia and chronic sialorrhea.Furthermore, FDA-approved botulinum toxin drug products bear a boxed warning, commonly referred to as a “black box warning,” which is the strongest warning FDA requires, indicating that the drug carries a significant risk of serious or even life-threatening adverse effects. The boxed warning addresses the risk of distant spread of toxin effect to produce symptoms consistent with botulinum toxin effects. In addition, swallowing and breathing difficulties can be life threatening and there have been reports of death.Misbranded Drugs:A drug is misbranded under section 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)] if its labeling fails to bear adequate directions for use. “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (see 21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1) of the FD&C Act [21 U.S.C. § 353(b)(1)] include those that, because of their toxicity or other potentiality for harmful effect, and/or the method of their use, and/or the collateral measures necessary for their use, are not safe for use except under supervision of a practitioner licensed by law to administer them. Prescription drugs, as defined in section 503(b)(1)(A) of the FD&C Act, can be used safely only at the direction, and under the supervision, of a licensed practitioner.Because the aforementioned drug is a prescription drug intended for conditions that are not amenable to self-diagnosis and treatment by a layperson, adequate directions cannot be written such that a layperson can use the products safely for their intended use. Consequently, the labeling for these drug products fail to bear adequate directions for use, causing them to be misbranded under section 502(f)(1) of the FD&C Act. In addition, because these drugs are not approved in the U.S., they are also not exempt under 21 CFR 201.115(a) from the requirements of section 502(f)(1) of the FD&C Act. By offering these drugs for sale to U.S. consumers, www.glowface.store is causing the introduction of misbranded drugs into interstate commerce in violation of section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].FDA is sending this warning letter to www.glowface.store because of the inherent risks to consumers who purchase misbranded and unapproved new drugs. This letter is not intended to identify all the ways in which your products or operations might be in violation of the law. It is your responsibility to ensure that all products you offer for sale are in compliance with the FD&C Act and its implementing regulations. You should take prompt action to address any violations of the FD&C Act (which may include the offer for sale of similarly misbranded and/or unapproved new drugs other than the drug products noted above). We advise you to review your websites, product labels, and other labeling and promotional materials to ensure that you are not misleadingly representing your products as safe and effective for a use for which they have not been approved by FDA and that you are not distributing misbranded and unapproved drug products in violation of the FD&C Act.Please notify this office in writing within 15 working days describing the specific steps you have taken to address any violations and to prevent their recurrence. Include an explanation of each step being taken to remedy and prevent the recurrence of any violations, as well as copies of related documentation. Failure to adequately address this matter may result in legal action, including, without limitation, seizure, and injunction, without further notice. If you cannot complete corrective action within 15 working days, state the reason for the delay and the time within which you will complete the corrections. This letter notifies you of our concerns and provides you with an opportunity to address them. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration within 15 working days.If you are not located in the U.S., please note that products that appear to be misbranded or unapproved new drugs 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 unapproved and misbranded products that cannot be legally sold to consumers in the U.S.Please direct your response and any inquiries to FDA at FDAInternetPharmacyTaskForce-CDER@fda.hhs.gov.Sincerely,/s/__________________________________Sangeeta Vaswani Chatterjee, Pharm.D.Acting DirectorOffice of Drug Security, Integrity, and ResponseOffice of ComplianceCenter for Drug Evaluation and Research