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），至2025年09月12日，我局已依法注销龙川县车田镇誉源大药房的《药品经营许可证》。现予以公布。许可证号许可证标明的有效期限企业名称法人代表/负责人注销日期注销原因粤DB7620002002025-10-14龙川县车田镇誉源大药房陈春梅2025年09月12日企业申请河源市龙川县市场监督管理局2025年9月15日

飞利浦医疗（苏州）有限公司报告，由于发现Tumorloc软件存在潜在安全问题，可能对患者构成风险，飞利浦医疗（苏州）有限公司对其生产的X射线计算机体层摄影设备主动召回。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》。

行政相对人名称 扬州皇轩日化有限公司 行政相对人类别 法人及非法人组织 统一社会信用代码 91321016MA1XC0NQ3J 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 杨会珍 法定代表人证件类型 身份证 法定代表人证件号码 6****************3 证件类型 证件号码 行政处罚决定书文号 苏药监扬处罚〔2025〕25号 违法行为类型 生产经营不符合技术规范的化妆品的行为，违反了《化妆品监督管理条例》第六条规定。 违法事实 扬州皇轩日化有限公司，生产经营不符合技术规范的化妆品的行为，违反了《化妆品监督管理条例》第六条规定，依据《中华人民共和国行政处罚法》第二十八条第一款、《化妆品监督管理条例》第六十条第二项规定，应予处罚。 处罚依据 依据《中华人民共和国行政处罚法》第二十八条第一款、《化妆品监督管理条例》第六十条第二项规定。 处罚类别 罚款;没收违法所得、没收非法财物 处罚内容 没收违法所得贰仟肆佰玖拾陆元整；处以罚款叁万元整， 罚款金额（万元） 3 没收违法所得没收非法财物的金额（万元） 0.2496 暂扣或吊销证照名称及编号 处罚决定日期 2025/09/15 处罚有效期 2026/03/15 公示截止期 2028/09/15 处罚机关 江苏省药品监督管理局 处罚机关统一社会信用代码 11320000014000394R 数据来源单位 江苏省药品监督管理局 数据来源单位统一社会信用代码 11320000014000394R 备注 公示截止期依据文件：市场监督管理行政处罚信息公示规定。罚款金额已确认。

行政相对人名称 扬州欧丝曼日化有限公司 行政相对人类别 法人及非法人组织 统一社会信用代码 91321016MA1NYB8D2D 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 顾俊 法定代表人证件类型 身份证 法定代表人证件号码 3****************2 证件类型 证件号码 行政处罚决定书文号 苏药监扬处罚〔2025〕28号 违法行为类型 生产经营不符合技术规范的化妆品的行为，违反了《化妆品监督管理条例》第六条规定。 违法事实 扬州欧丝曼日化有限公司，生产经营不符合技术规范的化妆品的行为，违反了《化妆品监督管理条例》第六条规定，依据《中华人民共和国行政处罚法》第二十八条第一款、《化妆品监督管理条例》第六十条第二项规定，应予处罚。 处罚依据 依据《中华人民共和国行政处罚法》第二十八条第一款、《化妆品监督管理条例》第六十条第二项规定。 处罚类别 罚款;没收违法所得、没收非法财物 处罚内容 没收违法所得叁佰肆拾柒元柒角伍分整；处以罚款壹万陆仟元整。 罚款金额（万元） 1.6 没收违法所得没收非法财物的金额（万元） 0.034775 暂扣或吊销证照名称及编号 处罚决定日期 2025/09/15 处罚有效期 2026/03/15 公示截止期 2028/09/15 处罚机关 江苏省药品监督管理局 处罚机关统一社会信用代码 11320000014000394R 数据来源单位 江苏省药品监督管理局 数据来源单位统一社会信用代码 11320000014000394R 备注 公示截止期依据文件：市场监督管理行政处罚信息公示规定。罚款金额已确认。

Delivery Method:VIA ELECTRONIC MAIL READ/DELIVERY RECEIPT REQUESTEDProduct:DrugsRecipient:inspire.clinic217 W Main Street Ste 110Grand Prairie,TX75050United Statesdoctor@inspire.clinicIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERSeptember 9, 2025inspire.clinic: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.inspire.clinic in August 2025 and has observed that your website offers various compounded drug products, including semaglutide and tirzepatide.1As described below, your claims concerning compounded semaglutide and tirzepatide products are false or misleading 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)], resulting 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 following claims concerning compounded semaglutide and tirzepatide products appear on your website:• “Semaglutide (similar to Ozempic) 2.5 mg vial”• “Tirzepatide (similar to Mounjaro) 10 mg vial”• “5 mg of semaglutide comparable to Ozempic. [sic]”Compounded drug products are not FDA-approved. Your claims imply that your products are the same as an FDA-approved product when they are 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 claims identified in this letter put you on notice of our concerns but do not represent an exhaustive list of misbranding violations.2For the reasons discussed above, your compounded semaglutide and tirzepatide 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.You should take immediate action to address any violations (including, for example, ceasing and desisting from using the language cited above that misbrands the product). 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 violations, as well as copies of related documentation. This letter notifies you of our concerns and provides you an opportunity to address them. If you believe your products are not in violation of the FDCA, include your reasoning and any supporting information for our consideration. 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 drugs 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/George Tidmarsh, M.D., Ph.D. DirectorCenter for Drug Evaluation and ResearchU.S. Food and Drug Administration1The semaglutide and tirzepatide 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.2Overstatements of efficacy or minimization of risk are of particular concern and may constitute misbranding.

Delivery Method:VIA ELECTRONIC MAIL READ/DELIVERY RECEIPT REQUESTEDProduct:DrugsRecipient:Bioverse, Inc. dba Bioverse875 Washington StreetNew York,NY10014United Statessupport@gobioverse.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERSeptember 9, 2025Bioverse: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.gobioverse.com in August 2025 and has observed that your website offers various compounded drug products, including semaglutide and tirzepatide.1As described below, your claims concerning compounded semaglutide and tirzepatide products are false or misleading 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)], resulting 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.he following claims concerning compounded semaglutide and tirzepatide products appear on your website:• “Same active ingredient as Ozempic and Wegovy”• “The same active ingredient in Mounjaro and Zepbound”• “Semaglutide, the same active ingredient in Ozempic and Wegovy, is a GLP-1 RA recognized for effective weight loss.”“Doctor-trusted ingredients, formulated with the same active ingredient as Ozempic and Wegovy”• “Weight loss specialists frequently prescribe compounded semaglutide, which contains the same active ingredient as Ozempic and Wegovy”Compounded drug products are not FDA-approved. Your claims imply that your products are the same as an FDA-approved product when they are 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 claims identified in this letter put you on notice of our concerns but do not represent an exhaustive list of misbranding violations.2For the reasons discussed above, your compounded semaglutide and tirzepatide 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.You should take immediate action to address any violations (including, for example, ceasing and desisting from using the language cited above that misbrands the product). 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 violations, as well as copies of related documentation. This letter notifies you of our concerns and provides you an opportunity to address them. If you believe your products are not in violation of the FDCA, include your reasoning and any supporting information for our consideration. 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 drugs 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/George Tidmarsh, M.D., Ph.D.DirectorCenter for Drug Evaluation and ResearchU.S. Food and Drug Administration1The semaglutide and tirzepatide 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.2Overstatements of efficacy or minimization of risk are of particular concern and may constitute misbranding.

根据《广东省食品药品监督管理局关于序号许可证号许可证的有效期限企业名称企业负责人注销日期注销原因1粤DB75895502025-11-25怀集县泳颐康药房有限公司怀集雅豪庭园分店李爱玲2024/11/22企业申请2粤DB75896162026-01-21怀集县泳颐康药房有限公司怀集惠景分店李爱玲2024/11/22企业申请3粤CB7580000072025-11-04广东邦健医药连锁有限公司怀集鸿景城分店曾土英2025/03/26企业申请4粤CB758A2252027-12-08怀集县怀城镇震震食品店张小鼎2025/03/27企业申请5粤DA7580002102028-01-08怀集众成医药有限公司黄祥欣2025/04/11企业申请6粤DB758A2282028-07-17怀集县和合医药有限公司韦炎业2025/04/16企业申请7粤DB75852292025-08-09怀集县都市百姓大药房陈剑彬2025/04/28企业申请8粤DB75893692025-05-25怀集县瑜源药房陈兴坚2025/05/07企业申请9粤DB75852782028-07-31怀集县仁恒源医药有限公司苏水波2025/08/04企业申请10粤DA7580001272029-08-25怀集县泳颐康药房有限公司蔡超瑾2025/08/05企业申请11粤CB7580001582026-04-25肇庆市养天和康民大药房连锁有限公司怀集城中路分店吴惠贞2025/08/25企业申请12粤CB7580002012026-04-25肇庆市养天和康民大药房连锁有限公司怀集雅豪庭园分店吴惠贞2025/08/25企业申请13粤DB75851652025-09-03怀集县健之友药房姚华源2025/09/11证书过期14粤DA75894402025-07-02怀集县存生堂药业有限公司江海容2025/09/11证书过期15粤DA75893972025-06-21怀集县为民药业有限公司梁天标2025/09/11证书过期16粤DA75893902025-06-16怀集县泰芝堂药业有限公司钱寿田2025/09/11证书过期17粤DA75893802025-06-09怀集县群康药业有限公司陈信荣2025/09/11证书过期18粤DA75892442025-04-01怀集县益寿药业有限公司梁一胜2025/09/11证书过期19粤DA75892422025-03-29怀集县成生堂药业有限公司叶成海2025/09/11证书过期20粤DB75890432024-11-04怀集县仁济医药有限公司怀集北角分公司黎任兰2025/09/11证书过期怀集县市场监督管理局2025年09月12日

依据《中华人民共和国行政许可法》《药品经营和使用质量监督管理办法》等法律法规规定，现决定依法注销天津布莱梅生物工程有限公司等2家企业的《药品经营许可证》。特此公告。附件：《药品经营许可证》注销企业名单2025年9月11日序号企业名称许可证编号注销原因1天津布莱梅生物工程有限公司津AA2220215有效期届满未延续2天津市江山大药房医药连锁有限公司津BA022i00042有效期届满未延续

亳州广源堂中药饮片有限公司：本局于2025年7月14日发布《安徽省药品监督管理局暂停生产销售通知书》（皖药监药暂停〔2025〕中化-7号），通知你单位暂停销售中药饮片。依据《药品生产监督管理办法》第五十九条第三款的规定，鉴于你单位安全隐患已依法处理，现决定解除相关产品的暂停销售措施。具体产品为：中药饮片。 安徽省药品监督管理局2025年9月12日