主体名称嘉兴美信医疗器械有限公司处罚决定书文号长市监处罚﹝2026﹞733号处罚类别罚款;没收非法财物处罚决定时间2026-06-15处罚内容当事人经营超过使用期限和标签不符合规定医疗器械的行为,违反了《医疗器械监督管理条例》第五十五条、第三十九条第一款和第二款之规定,根据《医疗器械监督管理条例》第八十六条第(三)项、第八十八条第一款第(二)项之规定,责令改正,本局决定对当事人作如下处理:1.没收违法经营的医疗器械:过期“紫明乐弗”人体润滑剂(无味型,50g)2份(生产批号:23202、240215);无标签标识的电极片2袋(每袋4片)。2.处罚款人民币壹万元整(￥10000.00),上缴国库。罚款金额（万元）1.000000没收违法所得0.000000暂扣或吊销证照名称及编号-违法行为类型嘉兴美信医疗器械有限公司经营无合格证明文件、过期、失效、淘汰的医疗器械案处罚依据《医疗器械监督管理条例》第八十六条第三项　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;　　;违法事实主要违法事实:2026年04月09日,被处罚人嘉兴美信医疗器械有限公司在长兴县某医院放置的自动售卖机内医疗器械超过使用期限和无标识标签(“紫明乐弗”人体润滑剂和无标签标识的电极片2袋)。行政处罚种类、依据、内容:当事人经营超过使用期限和标签不符合规定医疗器械的行为,违反了《医疗器械监督管理条例》第五十五条、第三十九条第一款和第二款之规定,根据《医疗器械监督管理条例》第八十六条第(三)项、第八十八条第一款第(二)项之规定,责令改正,本局决定对当事人作如下处理:1.没收违法经营的医疗器械:过期“紫明乐弗”人体润滑剂(无味型,50g)2份(生产批号:23202、240215);无标签标识的电极片2袋(每袋4片)。2.处罚款人民币壹万元整(￥10000.00),上缴国库。行政处罚履行方式和期限:当事人自收到行政处罚决定书之日起十五日内,按照行政处罚决定书载明的履行方式履行。处罚机关长兴县市场监督管理局处罚机关统一社会信用代码11330522094725597E数据来源单位省市场监管局数据来源单位统一社会信用代码11330000MB19062420

行政相对人名称乳源瑶族自治县大布镇中心卫生院行政相对人类别法人及非法人组织行政相对人代码统一社会信用代码12440232455896552X组织机构代码工商登记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胡烈敏行政处罚决定书文号乳医保罚字〔2026〕第7号违法行为类型造成医疗保障基金损失违法事实2025年1月1日至2025年12月31日期间,发现存在一般违规问题一大类,违反诊疗规范过度诊疗问题1个,共涉及49例,涉及违规金额44686.62元。处罚依据根据《医疗保障基金使用监督管理条例》第三十八条定点医药机构有下列情形之一的,由医疗保障行政部门责令改正,并可以约谈有关负责人;造成医疗保障基金损失的,责令退回,处造成损失金额1倍以上2倍以下的罚款;拒不改正或者造成严重后果的,责令定点医药机构暂停相关责任部门6个月以上1年以下涉及医疗保障基金使用的医药服务;违反其他法律、行政法规的,由有关主管部门依法处理:第(二)项违反诊疗规范过度诊疗、过度检查、分解处方、超量开药、重复开药或者提供其他不必要的医药服务。按照《行政处罚法》第三十二条、《规范医疗保障基金使用监督管理行政处罚裁量权办法》第十四条、《广东省医疗保障局行政执法减免责清单》从轻处罚清单第2类44028900D00Y第4项规定,该违法行为属于从轻处罚裁量档次。处罚类别罚款处罚内容1.责令立即改正违法行为;2.责令退回造成医疗保障基金损失金额肆万肆仟陆佰捌拾陆元陆角贰分(￥44686.62元);3.处造成医疗保障基金损失金额1.2倍罚款伍万叁仟陆佰贰拾叁元玖角肆分(￥53623.94元)罚款金额（万元）5.362394没收违法所得、没收非法财物的金额（万元）暂扣或吊销证照名称及编号处罚决定日期2026-06-17处罚机关乳源瑶族自治县医疗保障局

广西壮族自治区药品监督管理局行政处罚信息公开表序号行政处罚决定书文号案件名称当事人统一社会信用代码主要违法事实行政处罚的种类和依据做出处罚的机关名称和日期1桂药监玉分罚〔2026〕2号 广西正辉药业有限公司未遵守《药品经营质量管理规范》经营药品案广西正辉药业有限公司91450902MA5QHXA652当事人未遵守《药品经营质量管理规范》经营药品的行为，违反了《中华人民共和国药品管理法》第五十三条第一款的规定。行政处罚的种类：警告；罚款；责令停业。行政处罚的依据：《中华人民共和国行政处罚法》第二十八条和《中华人民共和国药品管理法》。广西壮族自治区药品监督管理局2026年06月09日

根据《国家药监局关于发布互联网药品医疗器械信息服务备案管理规定的公告》（2025年第123号），现就西宁中北健康科技有限公司医疗器械互联网信息服务首次备案情况公示如下。 附件：备案网站基本信息 青海省药品监督管理局 2026年6月17日 附件 备案网站基本信息 序号 证书编号 单位名称 法定代表人 住所 网站主服务器所在地域名 IP地址 网站名称 网站域名 服务性质 备案时间 备注 1 青网药械信备字〔2026〕000018号 西宁中北健康科技有限公司 王志炟 青海省西宁市城东区祁连路696号路家庄小区二期14号楼14-3商铺 xnzbkj.com 8.156.85.123 中北健康 xnzbkj.com 经营性 2026/6/16

序号1企业名称东港市医药公司企业类型药品批发检查时间2026年4月15日-2026年4月17日所在地市丹东市检查依据《药品管理法》《麻醉药品和精神药品管理条例》《药品经营和使用质量监督管理办法》《药品经营质量管理规范》等法律法规和规范。检查事项药品经营检查方式常规检查（日常）检查内容贯彻执行《药品管理法》《麻醉药品和精神药品管理条例》《药品经营和使用质量监督管理办法》等法律法规情况。存在问题在人员与培训方面，存在新法规未纳入年度培训计划的情况；在储存管理方面，存在个别药品存放库区有误的情况。处理措施责令限期整改。整改情况已按要求完成整改。序号2企业名称东北制药丹东医药有限公司企业类型药品批发检查时间2026年6月8日-2026年6月10日所在地市丹东市检查依据《药品管理法》《麻醉药品和精神药品管理条例》《药品经营质量管理规范》等法律法规和规范。检查事项药品经营检查方式常规检查（合并GSP符合性）检查内容贯彻执行《药品管理法》《麻醉药品和精神药品管理条例》《药品经营质量管理规范》等法律法规规范情况。存在问题在人员与培训方面，存在个别人员培训不到位的情况；在储存管理方面，存在药品区存放其他物品的情况；在设施设备方面，存在个别设备维护记录不全的情况。处理措施责令限期整改。整改情况已按要求完成整改。序号3企业名称宽甸同济堂医药连锁有限公司企业类型药品零售连锁总部检查时间2026年4月8日-2026年4月9日,2026年4月14日-2026年4月14日所在地市丹东市检查依据《药品管理法》《药品经营和使用质量监督管理办法》《药品经营质量管理规范》等法律法规和规范。检查事项药品经营检查方式常规检查（日常）检查内容贯彻执行《药品管理法》《药品经营和使用质量监督管理办法》《药品经营质量管理规范》等法律法规规范情况。存在问题在培训方面，存在新法规未纳入培训计划的情况；在设施设备方面，存在个别温湿度监测点位未按要求设置监测范围的情况。处理措施责令限期整改。整改情况已按要求完成整改。序号4企业名称丹东汇林泉大药房连锁有限公司企业类型药品零售连锁总部检查时间2026年5月14日-2026年5月17日所在地市丹东市检查依据《药品管理法》《药品经营和使用质量监督管理办法》《药品经营质量管理规范》等法律法规和规范文件 。检查事项药品经营检查方式常规检查（合并GSP符合性）检查内容贯彻执行《药品管理法》《药品经营和使用质量监督管理办法》《药品经营质量管理规范》等法律法规规范情况。存在问题在质量管理体系方面，存在未定期修订文件、个别质量管理制度及操作规程不健全的情况。处理措施责令整改。整改情况已按要求完成整改。序号5企业名称丹东漱玉健康大药房连锁有限公司企业类型药品零售连锁总部检查时间2026年6月3日-2026年6月5日所在地市丹东市检查依据《药品管理法》《药品经营和使用质量监督管理办法》《药品经营质量管理规范》等法律法规和规范。检查事项药品经营检查方式常规检查（日常）检查内容贯彻执行《药品管理法》《药品经营和使用质量监督管理办法》《药品经营质量管理规范》等法律法规规范情况。存在问题在设施设备方面，存在个别温湿度监控装置失灵，在温湿度超出限值时未发出报警信息的情况。处理措施责令限期整改。整改情况已按要求完成整改。

Delivery Method:Via Electronic Mail - Return Receipt RequestedReference #:320-26-94Product:Drugs;Over-the-Counter DrugsRecipient:Mr. Wayne KirbyOwnerSante Manufacturing Inc.516 John Street N 11A & 11BAylmer ON N5H 2B8CanadaIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter 320-26-94June 5, 2026Dear Mr. Kirby:Your facility is registered with the United States Food and Drug Administration (FDA) as a manufacturer of over-the-counter (OTC) drug products. FDA has reviewed the records you submitted in response to our July 7, 2025, request and subsequent correspondence for records and other information pursuant to section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) for your facility, Sante Manufacturing Inc., FEI 3021535057, at 516 John Street N 11A & 11B Aylmer, Ontario, Canada.This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations, parts 210 and 211 (21 CFR, parts 210 and 211).Because your methods, facilities, or controls for manufacturing, processing, packing, or holding of drugs as described in your response to our 704(a)(4) request do not conform to CGMP, your drug products 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)).Following review of records and other information provided pursuant to section 704(a)(4) of the FD&C Act, significant violations were observed including, but not limited to, the following:1. Your firm failed to conduct at least one test to verify the identity of each component of a drug product. Your firm also failed to validate and establish the reliability of your component supplier’s test analyses at appropriate intervals (21 CFR 211.84(d)(1) and 211.84(d)(2)).Your firm manufactures OTC drug products such as (b)(4). Based on the records and information you provided, you did not demonstrate that you adequately tested each shipment of each lot of incoming (b)(4), a component at high risk for (b)(4) contamination, prior to its use in manufacturing. This includes testing of (b)(4) used in manufacturing drug products to determine its appropriate identity. Your firm also relied on the supplier’s certificate of analysis (COA) and accepted the (b)(4) component based on your supplier’s COA without establishing the reliability of your supplier’s test analyses at appropriate intervals.The use of ingredients contaminated with (b)(4) has resulted in various lethal poisoning incidents in humans worldwide. See (b)(4) to help you meet the CGMP requirements when manufacturing drugs containing ingredients at high-risk for (b)(4) contamination at (b)(4).Without adequate testing and confirmation of reliability of supplier test results, you lack scientific evidence that the components or drug products conform to appropriate specifications prior to use in the drug products you manufacture.In response to this letter, provide:A commitment to provide (b)(4) test results, no later than 30 calendar days from the date of this letter, from testing retains for all lots of high-risk drug components used in the manufacture of drug products. Alternatively, if a retain of a component lot is unavailable, perform retain sample testing of all implicated finished drug product batches for the presence of (b)(4).A full risk assessment for drug products that are within expiry which contain any ingredient at risk for (b)(4) contamination (including, but not limited to, (b)(4)). Take prompt and appropriate actions to determine the safety of all lots of the component(s) and any related drug product that could contain (b)(4), including customer notifications and product recalls for any contaminated lots. Identify additional appropriate corrective actions and preventive actions (CAPA) that secure supply chains in the future, including, but not limited to, ensuring that all incoming raw material lots are from fully qualified manufacturers and free from unsafe impurities. Detail these actions in your response to this letter.A description of how you will test each component lot for conformity with all appropriate specifications for identity, strength, quality, and purity. If you intend to accept any results from your supplier’s COA instead of testing each component lot for strength, quality, and purity, specify how you will robustly establish the reliability of your supplier’s results through initial validation as well as periodic revalidation. In addition, include a commitment to always conduct at least one specific identity test for each incoming component lot. In the case of (b)(4), and certain additional high-risk components we note that this includes the performance of parts (b)(4) of the United States Pharmacopeia (USP) monograph.The chemical quality control specifications you use to test each incoming lot of high-risk drug components to determine acceptability for use in manufacturing.A comprehensive, independent review of your material system to determine whether all suppliers of components, containers, and closures, are each qualified and the materials are assigned appropriate expiration or retest dates. The review should also determine whether incoming material controls are adequate to prevent use of unsuitable components, containers, and closures.2. Your firm failed to establish adequate written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(a)).Based on the records and information you provided, you did not demonstrate that you have adequately qualified your (b)(4) system. Additionally, you did not demonstrate that you adequately monitor your (b)(4) system. Because you use (b)(4) from this system as a component in your drug products, you should ensure that it meets, at a minimum, the USP (b)(4) monograph testing requirements and appropriate microbial limits in light of its intended use. Further, you did not demonstrate that you have an appropriate process validation program.Process validation evaluates the soundness of design and state of control of a process throughout its lifecycle. Each significant stage of a manufacturing process must be designed appropriately and assure the quality of raw material inputs, in-process materials, and finished drugs. Process qualification studies include intensive monitoring and testing throughout each significant process stage to characterize intra-batch variation and evaluate batches to determine whether an initial state of control has been established.Successful process qualification studies are necessary before commercial distribution. Thereafter, ongoing vigilant oversight of process performance and product quality is necessary to ensure you maintain a stable manufacturing operation throughout the product lifecycle.See FDA’s guidance document Process Validation: General Principles and Practices for general principles and approaches that FDA considers appropriate elements of process validation at https://www.fda.gov/media/71021/download.In response to this letter, provide:A detailed summary of your validation program for ensuring a state of control throughout the product lifecycle along with associated procedures. Describe your program for process performance qualification (PPQ) and ongoing vigilant monitoring of both intra-batch and inter-batch variation to ensure a continuing state of control. Also, describe your equipment and facility qualification program.A timeline for performing appropriate PPQ for each of your marketed drug products. Also provide a risk assessment and any follow-up actions to be taken for the distributed drug products produced without performing any process validation studies.Process performance protocol(s), and written procedures for qualification of equipment and facilities.A procedure for your (b)(4) system monitoring that specifies routine microbial testing of (b)(4) to ensure its acceptability for use in each batch of drug products produced by your firm.The current action/alert limits for total counts and objectionable organisms used for your (b)(4) system. Ensure that the total count limits for your (b)(4) are appropriately stringent in view of the intended use of each of the products produced by your firm.A procedure governing your program for ongoing control, maintenance, and monitoring that ensures the system consistently produces (b)(4) that meets (b)(4) USP monograph specifications and appropriate microbial limits.3. Your firm’s quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22).Based on the records and the information you provided, you did not demonstrate that your quality unit (QU) adequately exercises its authority and responsibilities including, but not limited to, implementing effective procedures and conducting adequate oversight of the drug products you manufacture. For example, your QU failed to ensure:Establishment of an appropriate written testing program designed to assess the stability characteristics of drug products and to use results of stability testing to determine appropriate storage conditions and expiration dates (21 CFR 211.166(a)).Appropriate validation of your analytical methods (21CFR 211.160(b)).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 QU 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.Your firm’s quality systems are inadequate. For guidance on establishing and maintaining CGMP-compliant quality systems, see FDA guidance documents: Q8(R2) Pharmaceutical Development at https://www.fda.gov/media/71535/download, Q9(R1) Quality Risk Management at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/q9r1-quality-risk-management and Q10 Pharmaceutical Quality System at https://www.fda.gov/media/71553/download.In response to this letter, provide 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:A determination of whether procedures used by your firm are robust and appropriateProvisions for QU oversight throughout your operations to evaluate adherence to appropriate practicesA complete and final review of each batch and its related information before the QU disposition decisionOversight and approval of investigations and discharging of all other QU duties to ensure identity, strength, quality, and purity of all products.CGMP Consultant RecommendedBased upon the nature of the violations we identified at your firm, you should engage a consultant qualified as set forth in 21 CFR 211.34 to evaluate your operations and to assist your firm in meeting CGMP requirements. The qualified consultant should also perform a comprehensive six-system audit of your entire operation for CGMP compliance and evaluate the completion and efficacy of your CAPAs before you pursue resolution of your firm’s compliance status with FDA.Your use of a consultant does not relieve your firm’s obligation to comply with CGMP. Your firm’s executive management remains responsible for resolving all deficiencies and systemic flaws to ensure ongoing CGMP compliance.ConclusionThe violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations.FDA placed all drugs and drug products offered for import into the United States from your firm on Import Alert 66-40 on April 27, 2026.Correct any violations promptly. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP. We may inspect to verify that you have completed corrective actions to any violations.Failure to address any violations may also result in the FDA continuing to refuse admission of articles manufactured at Sante Manufacturing Inc., at 516 John Street N 11A & 11B, Aylmer, Ontario, Canada, 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 days. Specify what you have done to address any violations 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 3021535057 and ATTN: LaKeesha M. Sifontes.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and Research

Delivery Method:VIA ELECTRONIC MAIL READ/DELIVERY RECEIPT REQUESTEDProduct:DrugsRecipient:Trinity HealthCare Supply, LLC dba altRx3206 NE 2nd Ave, Suite 3013Miami, FL 33137United Stateshelp@altrx.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesJune 8, 2026WARNING LETTERReference number: MARCS-CMS 728236To altRx:This warning letter advises you of significant violations identified 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. The violations cited in this letter are not intended to be an all-inclusive list of violations that may exist in connection with your products. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.FDA ReviewViolations were identified and documented during a review of altRx’s website, https://www.altrx.com, FDA Establishment Identifier (FEI) 3044175714, in May 2026. FDA observed that your website offers compounded drug products, including semaglutide and tirzepatide products.1 As described below, your website’s false or misleading claims concerning compounded semaglutide and tirzepatide products under sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [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 FD&C Act [21 U.S.C. § 331(a)]. This review was conducted under FDA’s public health responsibilities to protect the public from unsafe, ineffective, and poor quality drug products.Violations of the Federal Food, Drug, and Cosmetic ActThe 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.Your representations regarding compounded semaglutide and tirzepatide products are false or misleading. Under section 502(a) of the FD&C Act [21 U.S.C. § 352(a)], a drug product is misbranded if its labeling is false or misleading in any particular. Furthermore, under section 502(bb) of the FD&C Act [21 U.S.C. § 352(bb)], a compounded drug product is misbranded if its advertising or promotion is false or misleading in any particular.More specifically,1. The compounded semaglutide and tirzepatide products displayed on your website identify “altRx” on the pictured label, suggesting altRx is the compounder of those drugs when in fact it is not.22. The following claims concerning compounded semaglutide and tirzepatide products appear on your website:“GLP-1s are clinically proven medications….”“…clinically proven weight loss.”Compounded drug products are not FDA-approved. Your claims represent that the compounded drug products you offer have been FDA-approved or otherwise evaluated for safety and effectiveness when they have not.Accordingly, these representations cause your compounded drug products to be misbranded under sections 502(a) and 502(bb) of the FD&C Act [21 U.S.C. §§ 352(a) and (bb)]. 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)]. The violations described in this letter put you on notice of our concerns but may not represent an exhaustive list of violations. Please be advised, the receipt in interstate commerce of misbranded drug products, and the delivery or proffered delivery thereof, is also a violation of section 301(c) of the FD&C Act [21 U.S.C. § 331(c)].You are responsible for investigating and determining the root causes of any violations and implementing corrective and preventative measures to ensure future and sustained compliance so that these violations and any others do not occur. 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 FD&C Act, including the new drug approval requirements.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 and sustained compliance so that these violations and any others do not occur.Send your written response to the Office of Compounding Quality and Compliance (OCQC) within the Center for Drug Evaluation and Research (CDER)’s Office of Compliance at compoundinginspections@fda.hhs.gov within fifteen (15) business days of receipt of this letter. Identify your written response with reference number MARCS-CMS 728236 and Response to Warning Letter in the subject line of the email. 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. Such steps may include the following:1. Identifying the entities that produce the compounded drug products offered on your website;2. Providing a representative sample of labeling for such drug products; and3. Addressing other website claims that contain false or misleading representations about your compounded drug products or demonstrating that such claims have been modified or removed in light of FD&C Act §§ 502(a) and 502(bb) [21 U.S.C. §§ 352(a) and 352(bb)].This letter notifies you of our concerns and provides you an opportunity to address them. 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. If you cannot completely address this matter within fifteen (15) business 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 drug 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 drug products referenced above appear to be misbranded drug products that cannot be legally sold to consumers in the U.S.Please note FDA posts warning letters on www.FDA.gov.Sincerely,/S/Matthew J. Lash, JDActing DirectorOffice of Compounding Quality and ComplianceOffice of ComplianceCenter for Drug Evaluation and ResearchU.S. Food and Drug Administration__________________________1 The semaglutide and tirzepatide products offered on your website 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 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 FD&C Act [21 U.S.C. § 321(p)] because they are not generally recognized as safe and effective for their labeled uses.2 See 21 C.F.R. § 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.”); see also FD&C Act § 503(b) [21 U.S.C. § 353(b)], FD&C Act § 503B(a)(10)(A)(ii) [21 U.S.C. § 353b(a)(10)(A)(ii)]. We note that 21 C.F.R. § 201.1(a) does not apply to drug products dispensed in accordance with section 503(b)(1) of the FD&C Act [21 U.S.C. § 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 FD&C Act [21 U.S.C. § 353(b)(1)], nor do they appear to comply with the requirements of section 503(b)(2) [21 U.S.C. § 353(b)(2)].

昆明三稻医疗设备有限公司报告，由于产品铭牌警示标志不符合要求，昆明三稻医疗设备有限公司对其生产的造影通液推注仪（注册证编号：滇械注准20192060075）主动召回。召回级别为三级召回。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6月16日

根据《药品网络销售监督管理办法》（国家市场监督管理总局令第58号）及《云南省药品网络销售监督管理办法实施细则（试行）》相关要求，现将云南先施药业有限公司药品网络销售第三方平台备案事项公示如下：备案编号（滇）网药平台备字〔2026〕第000004-000号企业名称云南先施药业有限公司法定代表人谭 奇网站名称先施易采网络客户端应用程序名\网站域名https://yyweb.ynxsyy.com/#/网站IP地址139.155.127.72电信业务经营许可证编号滇B2-20230060非经营性互联网信息服务备案编号滇ICP备2020008150号；滇网药械信备字〔2025〕000054号