案例一：洛阳市嵩县某零售药店未按规定凭处方销售处方药案　　一、基本违法事实　　2025年3月25日，执法人员在日常检查中发现，洛阳市嵩县某大药房未凭处方销售处方药天王补心丸，执法人员依法责令其立即改正，下达《责令改正通知书》，要求其处方药必须凭执业医师或执业助理医师处方才可调配、购买。4月15日，执法人员对该药房复查，发现其未凭处方销售处方药酒石酸美托洛尔片，仍未改正其违法行为。　　二、立案查处情况　　当事人的行为违反了《药品经营和使用质量监督管理办法》第四十二条第一款“药品零售企业应当遵守国家处方药与非处方药分类管理制度，按规定凭处方销售处方药，处方保留不少于五年”的规定。鉴于当事人违法行为危害范围较小、程度较轻、社会危害后果较小，依据相关裁量规则，裁量等级为从轻。依据《药品经营和使用质量监督管理办法》第七十二条第(一)项“药品零售企业未按规定凭处方销售处方药的，由药品监督管理部门责令限期改正；逾期不改正的，处五千元以上五万元以下罚款；造成危害后果的，处五万元以上二十万元以下罚款”的规定，嵩县市场监督管理局于2025年5月28日作出行政处罚决定，对该药房处以罚款7000元。　　三、主要经验做法　　1、各县区局结合“清源”行动对零售药店进行全面排查，市局对各县区开展情况进行督导检查。重点检查内容包括是否从合法渠道购进药品，索证索票是否齐全，执业药师是否在职在岗，处方药是否凭处方销售。重点检查范围包括：城区人口流动较大的老旧小区周边单体药店、2024年以来新开办单体药店、曾被药品追溯APP预警过的零售药店、三甲医院周边的特药专业药房、网络销售规模较大的连锁药店等。　　2、充分发挥药品追溯系统的作用，利用药品追溯APP，重点对国家局触发式追溯监管模块中出现的追溯异常企业、多次被药品追溯APP 预警的企业进行监管和回头看，利用智慧监管手段协同查处回流药，切实杜绝非法渠道购进药品以及销售假劣药品。　　四、工作启示　　现场检查处方药凭处方销售问题，可查询药店的日销售记录，根据日销售记录检索出处方药查看留存处方。基层监管人员安装药品追溯APP，可大大提高现场检查效率，快速发现流向异常的药品。在日常检查中，对心脑血管类用药进行重点监控，通过手机APP快速扫码，可精准定位疑似回流药品，有效打击非法渠道购进药品等行为。案例二：许昌市某零售药店未从药品上市许可持有人或者具有药品生产、经营资格的企业购进药品案　　一、基本违法事实　　接举报事项调查处理函，2025年4月27日禹州市市场监管局执法人员对辖区某零售药店进行检查，现场检查未发现举报人反映的药品“健兴肺力咳合剂”，依据举报人提供的购药微信转账记录，执法人员现场调取该药店销售药品的微信转账记录，发现微信转账在4月3日上午一笔24元的药品销售收入，当事人不能说明销售的“健兴肺力咳合剂”是那个批次的，执法人员现场出示了举报人提供的2025年4月3日上午10时在该药店购买的药品照片，及举报人于2025年4月3日上午10时在该药店购买上述药品1瓶24元的微信转账截图打印件，经当事人现场予以确认是该零售药店销售的药品。当事人现场不能提供购进上述药品的供应商资质及购进票据。执法人员于2025年5月7日对该零售药店未从药品上市许可持有人或者具有药品生产、经营资格的企业购进药品进行立案。　　二、查处情况　　经查，该零售药店未从药品上市许可持有人或者具有药品生产、经营资格的企业购进药品，不能提供药品的供应商资质及购进票据，涉嫌构成非法渠道购进药品的违法行为。依据《中华人民共和国药品管理法》第一百二十九条：“违反本法规定，药品上市持有人、药品生产企业、药品经营企业或者医疗机构未从药品上市许可持有人或者具有药品生产、经营资格的企业购进药品的，责令改正，没收违法购进的药品和违法所得，并处违法购进药品货值金额二倍以上十倍以下的罚款；情节严重的，并处货值金额十倍以上三十倍以下的罚款；吊销药品批准证明文件、药品生产许可证、药品经营许可证或者医疗机构执业许可证；货值金额不足五万元的，按伍万元计算”的规定。责令当事人立即改正违法行为，经负责人集体讨论决定，最终作出减轻处罚罚款3万元的行政处罚。　　三、主要经验做法　　1.通过投诉举报人提供的证据材料与药品经营企业“票据+实物+系统台账记录+转账记录”四核对：本案突破点在于对药品经营企业当事人是否主动承认销售过从非法渠道购进的药品。执法人员不满足于形式审查，通过仔细核对票据、药品登记记录、销售药品微信转账记录、药品实物批号与系统记录的一致性。让当事人主动配合承认自己的违法事实。　　2.深挖线索，固定证据链：针对药店负责人最初含糊其辞的情况，执法人员通过调取药店销售记录、查询微信转账记录、询问关键人员等方式，并获取了关键证言，形成完整证据链。　　3.聚焦重点品种与高风险环节：将抗生素、慢性病用药等常用药及冷链药品作为检查重点，将票据溯源作为核查进货渠道的关键环节，提升了检查的靶向性和有效性。　　四、工作启示　　1.票据溯源是“清源”核心：药品购进票据是追溯来源、保障质量的关键凭证。必须将票据查验作为日常监管和专项整治的重中之重，提升执法人员鉴别真伪票据的能力。　　2.落实企业主体责任是根本：此案暴露出部分药店主体责任意识淡薄，内部质量管理体系形同虚设。必须持续高压震慑与引导教育并重，督促企业严格执行GSP，特别是进货查验、记录制度，筑牢安全防线。　　3.智慧监管与现场检查需深度融合：在利用好药品追溯系统等信息化手段进行线上监测预警的同时，必须强化线下现场检查的深度和精准度，特别是对票、货、账的实质性核查，防止“两张皮”。　　4.协同联动提升效能：打击药品流通领域违法违规行为，需加强市场监管、公安、卫健等部门的协作，尤其是在查处非法渠道、假劣药品、伪造票据等方面，形成监管合力。　　5.闭环管理强化震慑：对查实的违法行为必须依法严惩，公开曝光，并做好后续整改复查，确保处罚到位、整改到位，实现“查处一案、警示一片、规范一方”的效果。

全省各级药品监督管理部门深入贯彻落实省委、省政府和国家药监局有关加强药品安全工作的决策部署，深入开展药品经营环节“清源”行动，严厉打击药品经营违法违规行为，切实保障人民群众身体健康和用药安全。现将第一期“清源”行动违法违规典型案例公布如下：1.景德镇市乐平市天天好药品超市非法渠道购进药品案2025年4月，景德镇乐平市市场监督管理局根据国家医保局下发的追溯码疑点线索对乐平市天天好药品超市开展现场检查，发现该药店从不具备药品经营资质的个人处购进药品并全部销售。该药店上述行为违反《中华人民共和国药品管理法》第五十五条规定。2025年6月，乐平市市场监督管理局依据《中华人民共和国药品管理法》第一百二十九条、《江西省药品监督管理行政处罚裁量权适用规则》第十条规定，对该药店处以没收违法所得190元、罚款10000元的行政处罚。2.赣州市寻乌县康信药房非法渠道购进药品案2025年4月，赣州市寻乌县市场监督管理局根据医保部门移送的线索对寻乌县康信药房进行现场核查，发现该药店从不具备药品经营资质、上门推销药品的人员处非法购进药品。药品追溯码显示该药品已由寻乌县医疗机构流出，属于典型的“回流药”。该药房上述行为违反《中华人民共和国药品管理法》第五十五条规定。寻乌县市场监督管理局依据《中华人民共和国药品管理法》第一百二十九条和《江西省药品监督管理行政处罚裁量权适用规则》第十条的规定，对该药房处以没收违法购进的药品，没收违法所得224元、罚款20000元的行政处罚。3.九江市湖口县舜德乡南湾村卫生室非法渠道购进药品案2025年4月，湖口县市场监督管理局根据县医保局移送线索对舜德乡南湾村卫生室出现药品医保重复结算情况进行现场检查，发现该卫生室将家属从湖口县人民医院购买的药品（使用医保卡）用于卫生室诊疗使用，并予以医保结算。该卫生室上述行为违反了《中华人民共和国药品管理法》第五十五条规定。湖口县市场监督管理局依据《中华人民共和国药品管理法》第一百二十九条、《江西省市场监管领域从轻减轻行政处罚清单》相关规定，对该卫生室处以罚款3000元的行政处罚。4.宜春市万载县马步乡宝石村卫生所使用过期药品案2024年11月，宜春市万载县市场监督管理局依法对万载县马步乡宝石村卫生所进行监督检查，发现该卫生所药柜中摆放有排毒清脂片1盒、“修舒”健脾颗粒1盒、“冰中仙”冰硼散10瓶，上述药品已超过有效期。该卫生所上述行为违反《中华人民共和国药品管理法》第九十八条第三款第（五）项规定。2025年3月，万载县市场监督管理局依据《中华人民共和国行政处罚法》第二十八条第一款、《中华人民共和国药品管理法》等一百一十七条、《江西省药品行政处罚裁量权基准》第三条规定，对该卫生所处以罚款5000元的行政处罚。5.南昌市九州通三泰大药房有限公司从不具有药品经营资格的企业购进药品案2024年11月，南昌市高新区市场监督管理局根据举报对南昌市九州通三泰大药房有限公司进行检查，发现该公司从不具有药品经营资格的企业购进药品，并通过京东商城第三方平台销售。该公司上述行为违反《中华人民共和国药品管理法实施条例》第五十五条规定。南昌市高新区市场监督管理局依据《中华人民共和国药品管理法》第一百二十九条、《江西省药品监督管理行政处罚裁量权适用规则》第九条和第十条规定，对该公司处以没收违法所得215元、罚款15000元的行政处罚。6.抚州市广昌县赤水镇章甫村卫生室非法渠道购进药品案2025年4月，抚州市广昌县市场监督管理局根据县医保局移送线索，对广昌县赤水镇章甫村卫生室涉嫌销售回流药进行核查，发现该卫生室将其从其他医疗机构购买的药品用于日常诊疗并进行了医保结算。该卫生室上述行为违反《中华人民共和国药品管理法》第五十五条规定。2025年5月，广昌县市场监督管理局依据《中华人民共和国药品管理法》第一百二十九条、《江西省药品监督管理行政处罚裁量权适用规则》第十条规定，对该卫生室处以没收违法所得4.8元、罚款5000元的行政处罚。合规提示：《中华人民共和国药品管理法》规定，药品经营企业应当从药品上市许可持有人或者具有药品生产、经营资格的企业购进药品。药品经营企业购销药品，应当有真实、完整的购销记录。从事药品经营活动，应当遵守药品经营质量管理规范，建立健全药品经营质量管理体系，保证药品经营全过程持续符合法定要求。《中华人民共和国药品管理法》规定，禁止生产（包括配制，下同）、销售、使用假药、劣药。有下列情形之一的，为劣药：（一）药品成份的含量不符合国家药品标准；（二）被污染的药品；（三）未标明或者更改有效期的药品；（四）未注明或者更改产品批号的药品；（五）超过有效期的药；（六）擅自添加防腐剂、辅料的药品；（七）其他不符合药品标准的药品。（省药监局药品经营处供稿）

Delivery Method:Via Electronic Mail - Delivery and Read Receipt RequestedProduct:DrugsRecipient:Lyndon R. LeitnerCEOStaska Pharmaceuticals, Inc.742 Evergreen DriveBennet,NE68317-2365United StatesIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERWL # 699291May 5, 2025Dear Mr. Leitner:You registered your facility with the U.S. Food and Drug Administration (FDA) as an outsourcing facility under section 503B of the Federal Food, Drug, and Cosmetic Act (FDCA) [21 U.S.C. § 353b]1on December 3, 2020, and most recently on December 18, 2024. From September 3, 2024, to September 18, 2024, an FDA investigator inspected your facility, Staska Pharmaceuticals, Inc., located at 742 Evergreen Drive, Bennet, NE 68317. During the inspection, the investigator noted that drug products you produced failed to meet the conditions of section 503B of the FDCA necessary for drugs produced by an outsourcing facility to qualify for exemptions from certain provisions of the FDCA. In addition, the investigator noted serious deficiencies in your practices for producing drug products intended or expected to be sterile, which put patients at risk.FDA issued a Form FDA 483 to your facility on September 18, 2024, and issued an amended Form FDA 483 on September 26, 2024. FDA acknowledges receipt of your facility’s responses, dated October 18, 2024, and January 31, 2025. FDA acknowledges that on September 30, 2024, your firm initiated a voluntary recall of one lot of Ascorbic Acid Solution for Injection 25,000mg/50mL (500mg/mL), 50mL single use vial, due to the presence of glass particulates.Based on this inspection, it appears you produced drugs that violate the FDCA.A. Compounded Drug Products under the FDCAUnder section 503B(b) of the FDCA, a compounder can register as an outsourcing facility with FDA. Drug products compounded by or under the direct supervision of a licensed pharmacist in an outsourcing facility qualify for exemptions from the drug approval requirements in section 505 of the FDCA [21 U.S.C. § 355(a)], the requirement in section 502(f)(1) of the FDCA [21 U.S.C. § 352(f)(1)] that labeling bear adequate directions for use and the Drug Supply Chain Security Act requirements in section 582 of the FDCA [21 U.S.C. § 360eee-1] if the conditions in section 503B of the FDCA are met.2An outsourcing facility, which is defined in section 503B(d)(4) of the FDCA [21 U.S.C. § 353b(d)(4)], is a facility at one geographic location or address that — (i) is engaged in the compounding of sterile drugs; (ii) has elected to register as an outsourcing facility; and (iii) complies with all of the requirements of this section. Outsourcing facilities must comply with other applicable provisions of the FDCA, including section 501(a)(2)(B) [21 U.S.C. § 351(a)(2)(B)], regarding current good manufacturing practice (CGMP), and section 501(a)(2)(A) [21 U.S.C. § 351(a)(2)(A)], regarding insanitary conditions. Generally, CGMP requirements for the preparation of drug products are established in Title 21 of the Code of Federal Regulations (CFR) parts 210 and 211.In addition, for a drug product compounded using bulk drug substances to qualify for exemptions under section 503B, each bulk drug substance used to compound a drug product must be manufactured by an establishment that is registered under section 510 of the FDCA [21 U.S.C § 360] (section 503B(a)(2)(C) of the FDCA [21 U.S.C. § 353b(a)(2)(C)]).Furthermore, for a compounded drug product to qualify for the exemptions under section 503B, the labeling of the drug must include certain information (section 503B(a)(10) of the FDCA [21 U.S.C. §353b(a)(10)]).B. Failure to Meet the Conditions of Section 503BDuring the inspection, the FDA investigator noted that drug products produced by your facility failed to meet the conditions of section 503B. For example, the investigator noted:1. Your facility compounded drug products using a bulk drug substance from(b)(4), which is not a registered establishment under section 510 of the FDCA.2. Some of your facility’s drug products, such as(b)(4)and Glutathione Solution 2000mg/10ml (200mg/ml), did not include the following information on the container: information to facilitate adverse event reporting: www.fda.gov/medwatch and 1-800-FDA-1088. In addition, some of your facility’s drug products, such as Ascorbic Acid Solution 25000mg/50ml (500mg/ml) and Lidocaine HCl 2% Buffered Solution 1000mg/50ml (20mg/ml), also did not include the following information on the container: directions for use, including, as appropriate, dosage and administration.Because your compounded drug products have not met all of the conditions of section 503B, they are not eligible for the exemptions in that section from the FDA approval requirements of section 505, the requirement under section 502(f)(1) that labeling bear adequate directions for use, and the Drug Supply Chain Security Act requirements described in section 582 of the FDCA.Specific violations are described below.C. Violations of the FDCAAdulterated Drug ProductsThe FDA investigator noted that drug products intended or expected to be sterile were prepared, packed, or held under insanitary conditions, whereby they may have become contaminated with filth or rendered injurious to health, causing your drug products to be adulterated under section 501(a)(2)(A) of the FDCA. For example, the investigator noted:1. Aseptic operators reaching into the ISO 5 laminar flow hood past their elbows during aseptic production. However, microbial contamination action limit for personnel monitoring of the elbows is(b)(4). This practice may introduce contamination into the ISO 5 work area.2. Your media fills were not performed under the most challenging or stressful conditions. Therefore, there is a lack of assurance that your firm can aseptically produce drug products within your facility.3. Your firm failed to perform adequate smoke studies under dynamic conditions to demonstrate unidirectional airflow within the ISO 5 area. Therefore, your products intended to be sterile are produced in an environment that may not provide adequate protection against the risk of contamination.The FDA investigator also noted CGMP violations at your facility, that caused your drug product(s) to be adulterated within the meaning of section 501(a)(2)(B) of the FDCA. The violations include, for example:1. Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192).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)).3. Your firm failed to ensure that each person engaged in the manufacture, processing, packing, or holding of a drug product has the education, training, and experience, or any combination thereof, to enable that person to perform his or her assigned functions (21 CFR 211.25(a)).4. Your firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas (21 CFR 211.42(c)(10)(iv)).5. Your firm failed to clean, maintain, and, as appropriate for the nature of the drug, sanitize and/or sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements (21 CFR 211.67(a)).6. Your firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes (21 CFR 211.113(b)).Outsourcing facilities must comply with CGMP requirements under section 501(a)(2)(B) of the FDCA. FDA’s regulations regarding CGMP requirements for the preparation of drug products have been established in 21 CFR parts 210 and 211. FDA intends to promulgate more specific CGMP regulations for outsourcing facilities. FDA has issued a revised draft guidance,Current Good Manufacturing Practice — Guidance for Human Drug Compounding Outsourcing Facilities under Section 503B of the FD&C Act. This draft guidance, when finalized, will describe FDA’s expectations regarding outsourcing facilities and the CGMP requirements in 21 CFR parts 210 and 211 until more specific CGMP regulations for outsourcing facilities are promulgated.Under section 301(a) of the FDCA [21 U.S.C. § 331(a)], the introduction or delivery for introduction into interstate commerce of any drug that is adulterated is a prohibited act. Further, it is a prohibited act under section 301(k) of the FDCA [21 U.S.C. § 331(k)] to do any act with respect to a drug, if such act is done while the drug is held for sale after shipment in interstate commerce and results in the drug being adulteratedUnapproved New Drug ProductsYou do not have any FDA-approved applications on file for drug products that you compound.3Under sections 505(a) and 301(d) of the FDCA [21 U.S.C. §§ 331(d)] a new drug may not be introduced into or delivered for introduction into interstate commerce unless an application approved by FDA under section 505 of the FDCA is in effect for the drug. Marketing of these products, or other applicable products, without an approved application violates these provisions of the FDCA.Misbranded Drug ProductsYou compound drug products that are intended for conditions not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layman can use these products safely for their intended uses. Consequently, their labeling fails to bear adequate directions for their intended uses causing them to be misbranded under section 502(f)(1) of the FDCA.4The introduction or delivery for introduction into interstate commerce of these products therefore violates section 301(a) of the FDCA. Further, it is also a prohibited act under section 301(k) of the FDCA to do any act with respect to a drug, if such act is done while the drug is held for sale after shipment in interstate commerce and results in the drug being misbranded.D. Corrective ActionsWe have reviewed your facility’s response to the Form FDA 483. We acknowledge that on September 30, 2024, your firm initiated a voluntary recall of one lot of Ascorbic Acid Solution for Injection 25,000mg/50mL (500mg/mL), 50mL single use vial, due to the presence of glass particulates.We are unable to fully evaluate some of your corrective actions due to lack of adequate supporting documentation:1. Regarding your firm’s failure to ensure that each person engaged in the manufacture, processing, packing, or holding of a drug product has the education, training, and experience, or any combination thereof, to enable that person to perform his or her assigned functions:a. We acknowledge your firm is committed to ensuring your qualification program is representative of current manufacturing operations, a robust training program is in place, and will draft procedures specific to the preparation and maintenance of defective units to align with routine manufacturing. However, you did not provide documentation ensuring your Quality Assurance staff will review the library of defective samples, including examples from the lower limits of visual detection and if new particulate matter defect will be added to the training library.b. We acknowledge your firm is committed to evaluate your empirical data and trends over the next(b)(4)to aid in the establishment of limits for the false rejection of acceptable units during qualification activities. However, your firm did not provide documentation supporting quality risk assessments during your developmental phase.c. We acknowledge your firm conducted training on 09/20/2024 with visual inspection operators related to proper technique requirements for full rotation. However, your firm did not provide documentation addressing corrective actions/preventative actions for the firm’s current visual inspection (VI) inspectors that passed VI qualification but did not adhere to the timeframe requirements set forth within the firm’s written procedure.2. Regarding your firm’s failure to establish an adequate system for monitoring environmental conditions in aseptic processing areas:a. We acknowledge that you have removed personnel monitoring fromSOP MC0l0, Environmental Monitoring, and drafted a new SOP MC028 Aseptic Filling Room Personnel Monitoring; however, you did not provide complete copies ofSOP MC028andSOP MC0l0. In addition, you stated a retrospective review of all personnel monitoring data for 2024 was performed; however, a completed copy of your firm’s retrospective review was not provided.b. We acknowledge that your firm recognized “the critical importance of aseptic technique in sterile drug product manufacturing” and initiated CAPA/PD/010/24 (Annexure 7.A.1). However, we could not evaluate your response due to lack of supporting documentation for the following line items:i. Item 1: Your SOP currently states “the limit for all ISO 5 gowning samples was set to(b)(4).” The correct limit should be

Delivery Method:VIA UNITED PARCEL SERVICE AND VIA E-MAILReference #:25-HFD-45-06-01Product:DrugsRecipient:Peter Michael, M.D.Peter Michael, M.D.1401 East 4th Avenue, Suite 201Hialeah,FL33010-3504United StatesIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERFDA Ref. No.: 25-HFD-45-06-01Dear Dr. Michael:This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted at your clinical site between June 3 and June 11, 2024. Investigator Angelica M. Chica, representing FDA, reviewed your conduct of the following clinical investigations:Protocol(b)(4), “(b)(4),” of the investigational drug(b)(4), performed for(b)(4).Protocol(b)(4), “(b)(4),” of the investigational drug(b)(4), performed for(b)(4).This inspection was conducted as a part of FDA’s Bioresearch Monitoring Program, which includes inspections designed to evaluate the conduct of research and to help ensure that the rights, safety, and welfare of human subjects have been protected.At the conclusion of the inspection, Investigator Chica presented and discussed with you the Form FDA 483, Inspectional Observations. We acknowledge receipt of your June 26, 2024, written response to the Form FDA 483.From our review of the FDA Establishment Inspection Report, the documents submitted with that report, and your written response dated June 26, 2024, it appears that you did not adhere to the applicable statutory requirements in the Federal Food, Drug, and Cosmetic Act (FD&C Act) and applicable regulations contained in Title 21 of the Code of Federal Regulations, part 312 (21 CFR 312) governing the conduct of clinical investigations and the protection of human subjects. We wish to emphasize the following:You failed to ensure that the investigation was conducted according to the investigational plan [21 CFR 312.60].As a clinical investigator, you are required to ensure that your clinical investigations are conducted in accordance with the investigational plan. The investigational plan for Protocol(b)(4)required the investigational drug,(b)(4), to be administered to pediatric subjects diagnosed with autism spectrum disorder, according to their age and in accordance with the protocol’s 8-week treatment regimen. According to the protocol’s(b)(4)dosing regimen, subjects between the ages of 5 and 9 years old were to receive a starting dose of 0.5 mg/day of(b)(4)on Day 1 (Visit 2), with a dose increase to 0.75 mg/day on Day 5. The protocol allowed for an optional dose increase to a maximum dose of 1.5 mg/day on Day 8 (Visit 3) for the 5-to-9-years-old age group.You failed to adhere to these requirements. Examples of this failure include, but are not limited to, the following:a. Subject(b)(6), a 9-year-old female, was administered 3 mg/day of(b)(4)oral solution from August 16, 2023, through August 31, 2023.b. Subject(b)(6), a 9-year-old male, was administered 3 mg/day of(b)(4)oral solution from August 16, 2023, through September 6, 2023.According to the protocol, the maximum dose allowed for these subjects was 1.5 mg/day. As a result, Subjects(b)(6)and(b)(6)received daily doses of(b)(4)that exceeded the daily dose allowed by the protocol. Specifically, Subjects(b)(6)and(b)(6)received twice the maximum daily dose of study drug for at least 16 and 22 days, respectively, which exposed them to an increased risk of adverse events.In your June 26, 2024, written response to the Form FDA 483, you stated that the overdosing of subjects was because of a misinterpretation of the study protocol and the unspecified dosing amounts provided within the protocol respective to each milligram dosage. You stated that when you became aware of these events in September 2023, the subjects’ doses were adjusted appropriately, and the subjects were screened for safety, with no concerns raised or adverse events or reactions reported.In addition, you stated that a Corrective and Preventive Action plan (CAPA) was immediately implemented to prevent recurrence, and no further incidents have occurred since then. As part of your CAPA, you stated that: (1) site staff were retrained on the dosing specifications; (2) site staff will contact the sponsor for guidance on protocol details that are vague or unspecified; and (3) additional pharmacy staff will be present when dosing to double-check the dose amount given to the subject to ensure that the appropriate dose is administered.While we acknowledge the corrective and preventive actions that your site has taken, your response is inadequate because you did not include sufficient details regarding the training or procedures implemented at your site to prevent similar violations in the future. In addition, your written response does not provide sufficient details about how you, as the clinical investigator, will ensure adequate oversight of study procedures (for example, adherence to protocol-specified dosing requirements). Given the significance of the protocol violation involving pediatric subjects, we request follow-up documentation regarding the training and procedures implemented at your site to ensure compliance with study protocol dosing procedures. Without this information, we are unable to determine if your corrective action plan is adequate to prevent similar violations in the future.We emphasize that as the clinical investigator, it is your responsibility to ensure that studies are conducted in accordance with the investigational plan, both to protect the rights, safety, and welfare of subjects and to ensure the integrity of study data. Your failure to conduct the clinical study in accordance with the protocol resulted in an overdose of investigational drug to pediatric subjects. This conduct raises significant concerns about your protection of the study subjects enrolled at your site and raises concerns about the validity and integrity of the data collected at your site.This letter is not intended to be an all-inclusive list of deficiencies with your clinical study of an investigational drug. It is your responsibility to ensure adherence to each requirement of the law and relevant FDA regulations. You should address any deficiencies and establish procedures to ensure that any ongoing or future studies comply with FDA regulations.This letter notifies you of our findings and provides you with an opportunity to address the deficiencies noted above. Within 15 business days of your receipt of this letter, you should notify this office in writing of the actions you have taken to prevent similar violations in the future. Failure to address this matter adequately may lead to regulatory action. If you believe that you have complied with the FD&C Act and relevant regulations, please include your reasoning and any supporting information for our consideration.Should you have any questions or concerns regarding this letter or the inspection, please email FDA at CDER-OSI-Communications@fda.hhs.gov. Your written response and any pertinent documentation should be addressed to:Brittany L. Garr-Colόn, MPHBranch ChiefCompliance Enforcement BranchDivision of Enforcement and Postmarketing SafetyOffice of Scientific InvestigationsOffice of ComplianceCenter for Drug Evaluation and ResearchU.S. Food and Drug AdministrationBuilding 51, Room 535210903 New Hampshire AvenueSilver Spring, MD 20993Sincerely yours,{See appended electronic signature page}David C. Burrow, Pharm.D., J.D.DirectorOffice of Scientific InvestigationsOffice of ComplianceCenter for Drug Evaluation and ResearchU.S. Food and Drug Administration--------------------------------------------------------------------------------------------This is a representation of an electronic record that was signed electronically. Following this are manifestations of any and all electronic signatures for this electronic record.--------------------------------------------------------------------------------------------/s/------------------------------------------------------------DAVID C BURROW06/18/2025 01:52:13 PM

Product:DrugsRecipient:www.buynetmeds.comIndiaIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesTO: www.buynetmeds.comFROM: The United States Food and Drug AdministrationRE: Notice of Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the InternetDATE: June 12, 2025WARNING LETTERThis is to advise you that the United States (U.S.) Food and Drug Administration (FDA) recently reviewed your website at the Internet address www.buynetmeds.com and has observed that your website introduces into interstate commerce misbranded and unapproved new drugs in violation of sections 301(a), 301(d), 301(k), 503(b), and 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. §§ 331(a), 331(d), 331(k), 353(b), and 355(a)].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.FDA has observed that www.buynetmeds.com introduces into interstate commerce unapproved and misbranded opioid drug products. Opioid addiction and abuse have created an immense public health crisis, and the death toll is staggering. Given the severity of the opioid epidemic, the easy availability of opioids via the Internet poses significant risks to U.S. consumers. FDA has also observed that www.buynetmeds.com introduces into interstate commerce unapproved and misbranded semaglutide drug products, including injectable versions. 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.buynetmeds.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.buynetmeds.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.On www.buynetmeds.com you offer for sale tapentadol, an opioid, marketed as:Asmanol 100mgAsmanol 100Aspadol 50mg | TapentadoIAspadol® 50Aspadol 75mgAspadol® 75Aspadol 100mgAspadol® TabEtadol 100mgETADOL 100Noosanta 100mgNoosanta 100Rin Tapenta 50mgRin-Tapenta™-50Tapaday 50MG | TapentadolTAPADAY 50Tapaday 100mg | TapentadolTAPADAY 100Tapaday O 100mgTapaday-O-100Tapal 100mg Tablets | TapentadolTapal 100Tapal-ER 100mgTapedac 100mgTapenax ER 50 TabletTapfree ER™ 100TAPFREE ER 100MGTapidol 50mg | TapentadolTapidol-50mgTAPIDOL 100MGTapidol-100Tapsmart 100 mgTapsmart-100Topcynta 50mgTOPCYNTA 50Topcynta 100MGTOPCYNTA 100Tprexadol 100mg | TapentadolTprexadol™-100Tydol 50mg | TapentadolTydol™ 50Tydol 100mgTydol™ 100Typendol 100mgYenta 100mgYenta-100Evidence obtained from your website establishing that these products are drugs intended for human use (as defined in 21 CFR 201.128) includes claims from each product’s description. Examples are listed below:“Asmanol 100mg (Tapentadol) is an opioid analgesic class medicine that is used to treat moderate to severe acute postoperative pain.”“Aspadol 50mg (Tapentadol) pill helps to relieve moderate to severe pain such as toothache, headache, or in conditions that affect joints and muscles.”“Etadol 100mg is a brand name for Tapentadol, a centrally acting analgesic that relieves pain in the brain and spinal cord.”“Noosanta 100 mg Tablet is an adult pain reliever intended to treat moderate to severe acute pain.”“Rin Tapenta 50mg Tablet is used to treat moderate to severe acute pain.”“Tapaday 100 mg tablet is a powerful medication that can provide relief for short-term acute pain…”“Tapal-ER 100mg is a prescription medication used to treat moderate to severe pain in adults.”“Tapedac 100mg Tablets are an adult-only prescription medicine used to treat moderate to severe acute pain.”“Tapenax ER 50 Tablet’s key advantage is that it gives good pain relief for moderate to severe pain.”“The prescription medication Tapfree ER 100mg is used to treat moderate to severe acute pain in adults.”“Adults who are experiencing moderate to severe acute pain may be prescribed a drug called Tapidol 100mg.”“Tapsmart 100 mg is treat [sic] for the management of moderate to severe pain in adults.”“Tapentadol hydrochloride is the active component of the pharmaceutical drug Topcynta 50mg.”“Tprexadol 100mg is prescribed to adults to relieve moderate to severe acute pain.”“Tydol 50mg is prescribed to adults to treat moderate to severe acute pain.”“Adults use Typendol 100mg to relieve moderate to severe acute pain.”“An adult painkiller called Yenta 100 mg Tablet is intended to treat moderate to severe acute pain.”While there are FDA-approved versions of tapentadol 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 the drug products, listed above, offered by www.buynetmeds.com. Currently, there are two tapentadol products that are FDA-approved for the U.S. market and these products are only available pursuant to a prescription from a licensed practitioner. FDA-approved tapentadol marketed under the brand name NUCYNTA is indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. FDA-approved tapentadol marketed under the brand name NUCYNTA ER is indicated for the management of severe and persistent pain, including neuropathic pain associated with diabetic peripheral neuropathy, that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate. FDA-approved tapentadol 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 risks including addiction, abuse, misuse, life-threatening respiratory depression (breathing problems), and neonatal opioid withdrawal syndrome (withdrawal symptoms in newborn baby). In addition, when tapentadol is taken in conjunction with other central nervous system depressants, including alcohol and benzodiazepines, use may result in coma or death.On www.buynetmeds.com you offer for sale semaglutide, including injectable versions, marketed as:Rybelsus 3mg TabletSemaglutide Tablets Rybelsus® 3mg 1 blister card of 10 tabletsRybelsus 7mgRybelsus® 7mg Semaglutida TabletasRybelsus 14mgSemaglutide Tablets Rybelsus® 14mg 1 blister card of 10 tabletsSemaglutide 0.25 mg InjectionFitaro™ 0.25Semaglutide 0.5 mg InjectionFitaro™ 0.5Semaglutide 1 mg InjectionFitaro™ 1Semaglutide 1.7 mg InjectionFitaro™ 1.7Semaglutide 2.4 mg InjectionFitaro™ 2.4Evidence obtained from your website establishing that these products are drugs intended for human use (as defined in 21 CFR 201.128) includes but is not limited to the following claims:“Rybelsus 3mg (semaglutide) is a type 2 diabetes medicine that acts as a glucagon-like peptide-1 (GLP-1) receptor agonist.”“Rybelsus 7mg (Semaglutide) Tablet is a type 2 diabetic medicine authorized by the FDA.”“Rybelsus 14mg (Semaglutide) Pills is a type 2 diabetic medicine authorized by the FDA.”“Semaglutide 0.5 mg injection is widely administered to people with type 2 diabetes who cannot maintain optimal glycemic control by diet and exercise alone or in combination with other antidiabetic drugs. It lowers blood sugar levels by boosting insulin secretion while lowering glucagon release.”“In addition to its function in diabetes management, semaglutide has been researched for its ability to promote weight reduction.”While there are FDA-approved versions of semaglutide 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 the drug products, listed above, offered by www.buynetmeds.com. Currently there are three semaglutide products that are FDA-approved for the U.S. market and these products are only available pursuant to a prescription from a licensed practitioner. FDA-approved semaglutide tablets marketed under the brand name RYBELSUS are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. FDA-approved semaglutide injection marketed under the brand name OZEMPIC is indicated as an adjunct to diet and exercise to improve glycemic control in individuals with type 2 diabetes mellitus and to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease. FDA-approved semaglutide injection marketed under the brand name WEGOVY is indicated as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in certain adult and pediatric patients. FDA-approved semaglutide products also bear a boxed warning, which again, 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 thyroid C-cell tumors.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 drugs are prescription drugs 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 drugs 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.buynetmeds.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)].Additionally, FDA has observed that www.buynetmeds.com offers prescription drugs for sale without a prescription. Under U.S. law, prescription drugs can be dispensed only pursuant to a prescription from a healthcare practitioner licensed by law to administer prescription drugs. By offering the aforementioned drugs without requiring a prescription, www.buynetmeds.com jeopardizes patient safety and misbrands the drugs under section 503(b)(1) of the FD&C Act. Dispensing a prescription drug without a prescription is an act which results in the drug being misbranded while held for sale, in violation of section 301(k) of the FD&C Act [21 U.S.C. § 331(k)].FDA is sending this warning letter to www.buynetmeds.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 drugs 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 Director, Office of Drug Security, Integrity, and ResponseOffice of ComplianceCenter for Drug Evaluation and Research

Delivery Method:VIA Electronic MailReference #:320-25-80Product:DrugsRecipient:Mr. Luv PatelOwnerHealwell Homeo Private LimitedPlot No. 215/1 220/1 & 221/1Village Indrad, Tal Kadi, District MehsanaAhmedabad382170GujaratIndiaIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter320-25-80June 12, 2025Dear Mr. Luv Patel:The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Healwell Homeo Private Limited, FEI 3028192440, Plot No. 215/1 220/1 & 221/1, Village Indrad, Tal Kadi, District Mehsana, Ahmedabad, Gujarat, from December 13 to 20, 2024.Your drug products are adulterated under section 501(a)(2)(A) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), in that they have been prepared, packed, or held under insanitary conditions, whereby they may have become contaminated with filth or rendered injurious to health.This warning letter also summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 211).Because your methods, facilities, or controls for manufacturing, processing, packing, or holding 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).As of the date of this letter, you have not responded to the Form FDA 483 inspectional observations, despite two inquiries from the Agency regarding your intent to do so. After FDA detained a shipment of drugs manufactured at your facility at the border on March 19, 2025, you sent an email, dated March 26, 2025, requesting a 90-day extension to respond to the Form FDA 483.During our inspection, our investigator observed specific violations including, but not limited to, the following.Insanitary ConditionsYour firm manufactures homeopathic and over-the-counter (OTC) drug products. Your drug products are adulterated under section 501(a)(2)(A) of the FD&C Act because they were prepared, packed, and held under insanitary conditions. Specifically, our investigator observed evidence of both rodent and avian activity, including the presence of live rodents and birds, as well as extensive rodent and avian excreta in areas where container-closure systems and finished drug products are stored. Further, the investigator observed the following:Apparent rodent excreta pellets throughout the finished product storage area, as well as areas containing drug packaging and packaging containers (boxes and uncapped(b)(4)vials).Birds living in storage areas, bird droppings and feathers on walls, floors, and throughout the packaging and labeling materials storage area.Unknown black mold-like material on the ceiling above manufacturing equipment and on the wall adjacent to open(b)(4)tanks and filling lines.Insects in manufacturing areas.Stray dogs loitering near open entryways with soiled(b)(4)serving as the only barrier to entry.(b)(4)used in manufacturing was stored outdoors in dirty drums.In response to this letter, provide:A comprehensive plan to decontaminate the facility, given the pervasive nature of the insanitary conditions.Your corrective action and preventive action plan to implement routine, vigilant operations management oversight of facilities and equipment. This plan should ensure, among other things, prompt detection of equipment/facilities performance issues, effective execution of repairs, adherence to appropriate preventive maintenance schedules, timely technological upgrades to the equipment/facility infrastructure, and improved systems for ongoing management review.Detailed procedures that demonstrate your firm can maintain buildings free from pests and that they remain in a clean and sanitary state.CGMP Violations1. 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 suppliers’ test analyses at appropriate intervals (21 CFR 211.84(d)(1)) and 211.84(d)(2).You failed to adequately test samples of your incoming components before using them to manufacture your homeopathic and OTC drug products. During the inspection, you informed the investigator that you reviewed certificates of analysis (COAs) for incoming materials, but did not perform identity testing, did not verify the supplier COA, and did not have a quarantine or approval process.Furthermore, you used(b)(4)as a component in some of your drug products. Our investigator documented that you received(b)(4)from your supplier in(b)(4)drums that bear the label(b)(4). You stated that you did not test this(b)(4)prior to use in production. It is unacceptable to not conduct identity testing on a drug competent, especially knowing it is labeled as another component.At a minimum, you must use(b)(4)(refer to USP General Chapter(b)(4)) to manufacture your non-sterile drug products.(b)(4)must be suitable for its intended use and routinely tested to ensure ongoing conformance with appropriate chemical and microbiological attributes. You have not demonstrated that the(b)(4)is suitable for use and meets the USP(b)(4)monograph.Without adequate testing, you do not have scientific evidence that the components conform to appropriate specifications prior to use in the manufacture of your drug products.In response to this letter, provide:A comprehensive 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.The chemical and microbiological quality control specifications you use to test and release each incoming lot of components for use in manufacturing.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.A summary of your program for qualifying and overseeing contract facilities that test the drug products you manufacture.Provide scientific justification to demonstrate the(b)(4)you use is suitable for use in drug manufacturing operations. If you determine the(b)(4)you used to manufacture drugs was not suitable, provide a detailed risk assessment addressing the potential effects on the quality of all drug product lots currently in U.S. distribution and within expiry. Specify actions you will take in response to the risk assessment.2. 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).During the inspection, our investigator observed that your quality unit (QU) did not provide adequate oversight for the manufacture of your OTC drug products. For example, your QU failed to ensure the following:Establishment of written procedures for numerous functions including, but not limited to, complaints, deviations, investigations, cleaning and maintenance of equipment, employee training, and labeling operations (21 CFR 211.22(d)).Adequate validation of production and process controls used in the manufacture of your drug products, including qualification of the equipment used in drug manufacturing (21 CFR 211.100(a)).Appropriate batch production and control records that include documentation of the accomplishment of each significant step in manufacturing of your drug products (21 CFR 211.188(b)).Adequate written procedures for test methods and sampling plans (21 CFR 211.160(b)).Adequate cleaning procedures as well as appropriate cleaning validation (21 CFR 211.67(a) and 211.67(b)).Your firm’s quality systems are inadequate. See FDA’s guidance documentQuality Systems Approach to Pharmaceutical CGMP Regulationsfor help implementing quality systems and risk management approaches to meet the requirements of CGMP regulations 21 CFR, parts 210 and 211 at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/quality-systems-approach-pharmaceutical-current-good-manufacturing-practice-regulations.In response to this letter, provide the following: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:o A determination of whether procedures used by your firm are robust and appropriate.o Provisions for QU oversight throughout your operations to evaluate adherence to appropriate practices.o A complete and final review of each batch and its related information before the QU disposition decision.o Oversight and approval of investigations and discharging of all other QU duties to ensure identity, strength, quality, and purity of all products.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 processHealwell Homeo Private Limited, Ahmedabad FEI 3028192440 page 5performance qualification (PPQ), and ongoing monitoring of both intra-batch and inter-batch variation to ensure a continuing state of control.A timeline for performing PPQ for each of your marketed drug products.A detailed program for designing, validating, maintaining, controlling, and monitoring each of your manufacturing processes that includes vigilant monitoring of intra-batch and inter-batch variation to ensure an ongoing state of control. Also, include your program for qualification of your equipment and facility.Drug RecallAfter the inspection, FDA made multiple unsuccessful attempts to schedule a teleconference with you to recommend removing your drug products from the U.S. market. On April 2, 2025, FDA held a call with your distributor,(b)(4), to provide notice of the conditions at your facility and recommend market action. On April 8, 2025,(b)(4), initiated a recall of products manufactured at your facility, currently in U.S. distribution.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 March 31, 2025.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 re-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 Healwell Homeo Private Limited, FEI 3028192440, Plot No. 215/1 220/1 & 221/1, Village Indrad, Tal Kadi, District Mehsana, Ahmedabad, Gujarat, 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 3028192440 and ATTN: Rokshana Safaai-Jazi.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and Research

序号行政处罚决定书文号案件名称违法企业名称或违法自然人姓名违法企业组织机构代码法定代表人姓名主要违法事实行政处罚的种类和依据行政处罚的履行方式和期限做出处罚的机关名称和日期备注1桂药监生稽罚〔2025〕12号桂林毕生药业有限公司生产销售劣柴胡（北柴胡）（批号：230938）案桂林毕生药业有限公司93450322MA5NJ92M89万华林梧州市食品药品检验所《检验报告》(报告编号:WZ2024YPC000129)，报告显示：标示生产单位为桂林毕生药业有限公司生产的柴胡（北柴胡）（批号：230938）【浸出物】为9.3%，标准规定为：“应不得少于11.0%”，不符合规定。依据《中华人民共和国药品管理法》第九十八条第三款第一项的规定，上述中药饮片柴胡（北柴胡）（批号：230938）依法定性为劣药，当事人生产销售劣药，违反《中华人民共和国药品管理法》第九十八条第一款的规定。桂林毕生药业有限公司生产销售劣药中药饮片柴胡（北柴胡）（批号：230938），违反了《中华人民共和国药品管理法》第九十八条第一款之规定，依据《中华人民共和国行政处罚法》第二十八条第一款，责令当事人立即改正上述违法行为，依据《中华人民共和国行政处罚法》第三十二条第一款第一项、《中华人民共和国药品管理法》第一百一十七条第一款，给予以下行政处罚：主动履行广西壮族自治区药品监督管理局2025年6月23日1.没收召回的中药饮片柴胡（北柴胡）（批号：230938）102.0公斤及留样244克；7.122.没收违法所得22438.00元（贰万贰仟肆佰叁拾捌圆）；3.并处生产劣药货值金额（货值金额48722.00元，不足十万元的，按十万元计算）的1.5倍罚款，即150000.00元（壹拾伍万元）。以上罚没款合计：172438.00元（壹拾柒万贰仟肆佰叁拾捌圆）。

东莞住友电木有限公司生产的肠梗阻导管套件，生产批号见附件，因公司内部抽样试验结果显示出货完毕的器械有可能无法满足技术要求中规定的性能指标。为了降低风险，决定对可能存在风险的售出器械实施召回，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》。　　附件：医疗器械召回事件报告表2025年6月30日