行政处罚信息公示摘要序号行政处罚决定书文号违法企业名称或自然人姓名法定代表人姓名违法企业组织机构代码违法行为类型主要违法事实行政处罚的内容行政处罚的依据履行方式和期限作出处罚决定的行政机关和日期1鄂药监汉江械处罚〔2025〕1号仙桃市洁美塑料制品有限公司郭红卫91429004695118864R生产、经营说明书、标签不符合规定的医疗器械当事人生产、经营说明书、标签不符合规定的医疗器械的行为，违反了《医疗器械监督管理条例》第三十九条第一款的规定。罚款《医疗器械监督管理条例》第八十八条第二项的规定主动履行，当事人收到行政处罚决定书之日起十五日内湖北省药品监督管理局2025年01月06日相关推荐CIO提供以下相关文库下载、合规服务以及线上培训课程学习。

行政相对人名称大连大仁堂(亳州)药业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913416003580012784法定代表人张敬德行政处罚决定书文号皖药监药处罚﹝2024﹞2-99号处罚类别罚款;没收违法所得;没收非法财物处罚决定日期2025-02-07处罚内容1.没收召回的茯苓粉（批号230201）193.185kg（64395袋）；2.没收违法所得45615.33元；3.罚款200000.00元，罚没款共计245615.33元。罚款金额（万元）20.000000没收违法所得、没收非法财物的金额（万元）4.561533暂扣或吊销证照名称及编号违法行为类型《中华人民共和国药品管理法》（2019年修订）第九十八条第一款、第三款违法事实标示为大连大仁堂（亳州）药业有限公司生产的茯苓粉（批号230201）经检验不符合规定。处罚依据《中华人民共和国药品管理法》（2019年修订）第一百一十七条第一款处罚机关安徽省药品监督管理局处罚机关统一社会信用代码11340000MB19570665数据来源单位安徽省药品监督管理局数据来源单位统一社会信用代码11340000MB19570665状态相关推荐CIO提供以下相关文库下载、合规服务以及线上培训课程学习。

行政处罚决定书文号：沈皇市监处罚﹝2025﹞12号处罚类别：罚款;没收违法所得处罚决定日期：2025-02-05处罚内容：1、没收违法所得52元； 2、罚款5000元。罚款金额(万元)：0.5违法行为类型：行政违法违法事实：未从具有资格企业购进药品处罚依据：依据《药品管理法》第一百二十九条处罚机关：沈阳市皇姑区市场监督管理局处罚机关统一社会信用代码：11210105MB05402774数据来源单位：沈阳市皇姑区市场监督管理局数据来源单位统一社会信用代码：11210105MB05402774相关推荐CIO提供以下相关文库下载、合规服务以及线上培训课程学习。

主体名称宁波市海曙春民大药房有限公司处罚决定书文号甬海市监处罚﹝2025﹞53号处罚类别罚款处罚决定时间2025-02-05处罚内容一、当事人销售的超过有效期的“参雄温阳胶囊”、“厄贝沙坦氢氯噻嗪片”、“枸橼酸氢钾钠颗粒”、“黄芪建中丸”,属《中华人民共和国药品管理法》第九十八条第三款第五项所指的劣药,当事人的行为违反了《中华人民共和国药品管理法》第九十八条第一款之规定,构成销售劣药的行为,鉴于当事人未曾发生过相同违法行为,积极配合市场监管部门调查并主动提供证据材料,对当事人销售劣药的行为,根据《中华人民共和国药品管理法》第一百一十七条第一款和《中华人民共和国行政处罚法》第五条第二款的规定,决定对当事人减轻处罚如下:1、没收超过超过有效期的4盒“参雄温阳胶囊”、1盒“厄贝沙坦氢氯噻嗪片”、1盒“枸橼酸氢钾钠颗粒”、13盒“黄芪建中丸”;2、罚款10000元;二、当事人未建立完整的销售记录的行为,违反了《中华人民共和国药品管理法》第五十七条之规定,构成未按照规定进行销售记录的行为,根据《中华人民共和国药品管理法》第一百三十条的规定,决定对当事人处理如下:1、责令改正;2、给予警告。三、当事人未按包装标示的温度要求储存“丁酸氢化可的松乳膏”、未按储存要求分类陈列含麻黄碱药品“氨麻美敏片(Ⅱ)”且未登记销售记录、处方药“头孢克洛分散片”未与非处方药分区陈列的行为,违反了《药品经营质量管理规范》第一百六十一条第一项、第三项及第一百七十条之规定,构成《中华人民共和国药品管理法》第五十三条第一款所指的未遵守药品经营质量管理规范的行为,根据《中华人民共和国药品管理法》第一百二十六条的规定,决定对当事人处理如下:1、责令限期改正:自收到行政处罚决定书之日起15日内改正;2、给予警告。四、当事人未按规定凭处方销售处方药“头孢克洛分散片”、未保留处方的行为,违反了《药品经营和使用质量监督管理办法》第四十二条第一款的规定,构成未按规定凭处方销售处方药的行为,根据《药品经营和使用质量监督管理办法》第七十二条第一项的规定,决定责令当事人限期改正:自收到行政处罚决定书之日起15日内改正。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-违法行为类型宁波市海曙春民大药房有限公司销售劣药案处罚依据《中华人民共和国药品管理法》第一百一十七条生产、销售劣药的,没收违法生产、销售的药品和违法所得,并处违法生产、销售的药品货值金额十倍以上二十倍以下的罚款;违法生产、批发的药品货值金额不足十万元的,按十万元计算,违法零售的药品货值金额不足一万元的,按一万元计算;情节严重的,责令停产停业整顿直至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制剂许可证。生产、销售的中药饮片不符合药品标准,尚不影响安全性、有效性的,责令限期改正,给予警告;可以处十万元以上五十万元以下的罚款。第一百一十八条生产、销售劣药且情节严重的,对法定代表人、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,并处所获收入百分之三十以上三倍以下的罚款,终身禁止从事药品生产经营活动,并可以由公安机关处五日以上十五日以下的拘留。对生产者专门用于生产假药、劣药的原料、辅料、包装材料、生产设备予以没收。;违法事实主要违法事实:经查明,当事人主要从事药品零售的经营活动。2024年9月14日上午,本局执法人员对当事人经营场所进行现场检查。在当事人经营场所药架上发现有“参雄温阳胶囊”4盒,生产日期2020.12.10,有效期至2023.11;“厄贝沙坦氢氯噻嗪片”1盒,生产日期2022年06月25日,有效期至2024年06月24日。在当事人经营场所的药柜内发现有“枸橼酸氢钾钠颗粒”1盒,生产日期2022/06/10,有效期至2024/05;“黄芪建中丸”13盒,生产日期2021年09月24日,有效期至2024年08月。上述4款药品于现场检查时皆已过期。因当事人未联入医保系统且未建立销售台账,故上述超过有效期的药品的具体销售情况及违法所得无法查明,本案中可查清的涉案超过有效期的药品数量为19盒,货值金额为1740元。另查明,检查当日当事人“OTC外用药”药架上放有2盒“丁酸氢化可的松乳膏”,处于常温保存状态,该药品包装盒上标注“【贮藏】避光、密闭、在阴凉处(不超过20℃)保存。”经查看现场湿温度计,现场温度31℃。检查当日,当事人经营场所有“氨麻美敏片(Ⅱ)”18盒,未专区存放且未登记销售,当事人计算机系统内无收货验收记录。现场另有“头孢克洛分散片”15盒,未登记处方单、处方药销售记录,当事人计算机系统内无收货验收记录,未与非处方药分区陈列。经系统查证,当事人未曾发生过相同违法行为。行政处罚种类、依据、内容:一、当事人销售的超过有效期的“参雄温阳胶囊”、“厄贝沙坦氢氯噻嗪片”、“枸橼酸氢钾钠颗粒”、“黄芪建中丸”,属《中华人民共和国药品管理法》第九十八条第三款第五项所指的劣药,当事人的行为违反了《中华人民共和国药品管理法》第九十八条第一款之规定,构成销售劣药的行为,鉴于当事人未曾发生过相同违法行为,积极配合市场监管部门调查并主动提供证据材料,对当事人销售劣药的行为,根据《中华人民共和国药品管理法》第一百一十七条第一款和《中华人民共和国行政处罚法》第五条第二款的规定,决定对当事人减轻处罚如下:1、没收超过超过有效期的4盒“参雄温阳胶囊”、1盒“厄贝沙坦氢氯噻嗪片”、1盒“枸橼酸氢钾钠颗粒”、13盒“黄芪建中丸”;2、罚款10000元;二、当事人未建立完整的销售记录的行为,违反了《中华人民共和国药品管理法》第五十七条之规定,构成未按照规定进行销售记录的行为,根据《中华人民共和国药品管理法》第一百三十条的规定,决定对当事人处理如下:1、责令改正;2、给予警告。三、当事人未按包装标示的温度要求储存“丁酸氢化可的松乳膏”、未按储存要求分类陈列含麻黄碱药品“氨麻美敏片(Ⅱ)”且未登记销售记录、处方药“头孢克洛分散片”未与非处方药分区陈列的行为,违反了《药品经营质量管理规范》第一百六十一条第一项、第三项及第一百七十条之规定,构成《中华人民共和国药品管理法》第五十三条第一款所指的未遵守药品经营质量管理规范的行为,根据《中华人民共和国药品管理法》第一百二十六条的规定,决定对当事人处理如下:1、责令限期改正:自收到行政处罚决定书之日起15日内改正;2、给予警告。四、当事人未按规定凭处方销售处方药“头孢克洛分散片”、未保留处方的行为,违反了《药品经营和使用质量监督管理办法》第四十二条第一款的规定,构成未按规定凭处方销售处方药的行为,根据《药品经营和使用质量监督管理办法》第七十二条第一项的规定,决定责令当事人限期改正:自收到行政处罚决定书之日起15日内改正。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。处罚机关宁波市海曙区市场监督管理局处罚机关统一社会信用代码11330203309059836N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相关推荐CIO提供以下相关文库下载、合规服务以及线上培训课程学习。

行政相对人名称：广东药爱堂大药房有限公司东莞东坑康利分店行政相对人类别：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91441900MA56TK0Y2344***********52法人代表姓名：饶玉清法定代表人证件类型：法定代表人证件号码：行政处罚决定书文号：东市监处罚〔2025〕300205026号违法行为类型：《中华人民共和国药品管理法》第五十七条“药品经营企业购销药品，应当有真实、完整的购销记录。购销记录应当注明药品的通用名称、剂型、规格、产品批号、有效期、上市许可持有人、生产企业、购销单位、购销数量、购销价格、购销日期及国务院药品监督管理部门规定的其他内容。”,《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。”违法事实：经查明，当事人于2024年10月16日购进药品克拉霉素胶囊（国药准字H20010655，批号2405032，生产厂家：江苏亚邦爱普森药业有限公司）10盒后，未按照规定记录购销存情况；当事人于2024年11月1日未凭处方单销售处方药阿奇霉素分散片（天津药业）2盒。当事人的违法行为于2024年11月5日被我局查获。、经查明，当事人于2024年10月16日购进药品克拉霉素胶囊（国药准字H20010655，批号2405032，生产厂家：江苏亚邦爱普森药业有限公司）10盒后，未按照规定记录购销存情况；当事人于2024年11月1日未凭处方单销售处方药阿奇霉素分散片（天津药业）2盒。当事人的违法行为于2024年11月5日被我局查获。处罚依据：《中华人民共和国药品管理法》第一百三十条“违反本法规定，药品经营企业购销药品未按照规定进行记录，零售药品未正确说明用法、用量等事项，或者未按照规定调配处方的，责令改正，给予警告；情节严重的，吊销药品经营许可证。”,《药品经营和使用质量监督管理办法》第七十二条第（一）项“药品零售企业有以下情形之一的，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：（一）未按规定凭处方销售处方药的；”处罚类别：其他-警告处罚内容：1、广东药爱堂大药房有限公司东莞东坑康利分店：警告、责令改正。罚款金额（万元）：没收违法所得、 没收非法财物的金额：暂扣或吊销证照名称及编号：处罚决定日期：2025-02-05公示截止期：2028-02-05处罚机关：东莞市市场监督管理局数据来源单位：东莞市市场监督管理局相关推荐CIO提供以下相关文库下载、合规服务以及线上培训课程学习。

Delivery Method:VIA Electronic MailReference #:320-25-32Product:DrugsRecipient:Mr. Wenbin ShenDirectorCenter for Instrumental Analysis of China Pharmaceutical UniversityNo. 24 Tongjiaxing RoadChina Pharmaceutical UniversityNanjing ShiJiangsu Sheng,210009ChinaIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter320-25-32January 23, 2025Dear Mr. Shen:The U.S. Food and Drug Administration (FDA) inspected your contract testing laboratory, Center for Instrumental Analysis of China Pharmaceutical University, FEI 3005037448, at Zhongyang Road, No. 24 Tongjiaxing Road, Nanjing, Jiangsu, from September 18 to 20, 2024.This warning letter summarizes significant deviations from Current Good Manufacturing Practice (CGMP) for active pharmaceutical ingredients (APIs).Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, the APIs you tested 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).We reviewed your September 23, 2024 response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence.During our inspection, our investigators observed specific deviations including, but not limited to, the following.1. Failure to have laboratory control records that include complete data derived from all laboratory tests conducted to ensure your API and intermediates complies with established specifications and standards.Your firm is a contract testing laboratory that analyzes APIs and intermediates, including samples of crude(b)(4),(b)(4), and(b)(4)USP, for the presence of(b)(4)using1H Nuclear Magnetic Resonance spectroscopy (NMR).Your firm failed to ensure that laboratory testing records were complete. For example, your test record of samples, “(b)(4)(USP) Experiment Records” for Lot(b)(4)contained only two lines of numbers with no explanation headers or titles. During the inspection, you explained that these numbers represented the testing date, lot number, and processing data for(b)(4)samples you analyzed for your customers. Further, the testing records did not document sample preparation, the test procedure(s), and system suitability. Additionally, not all the testing records were reviewed by a second person prior to the results being shared with your customers.Your firm also failed to ensure that laboratory records were readily available during the inspection. You informed our investigators that your(b)(4)1H NMR testing data before November 2023 were stored on external hard drives. However, when our investigators requested to review this data, you stated that it might be difficult to locate the data because there were many archived hard drives and only the archiving personnel could retrieve the data. As a result, you did not provide any CGMP data stored on the external hard drives for review during the inspection. We acknowledge that you provided limited data after the inspection.Additionally, your firm failed to ensure that your computerized systems, such as the computers used to control to the NMR equipment, and to store raw data files or process data, have adequate controls in place to prevent unauthorized access or changes to data. The NMR equipment was also used for academic teaching and research, and it appears that various users shared one login ID with full administrative access.In your response, you acknowledge your failure to keep adequate records and have now established procedures outlining requirements for laboratory documentation and sample tracking. You also state that you implemented user management settings on your computerized system and completed the system validation.Your response is inadequate because the procedures appear to lack sufficient detail to be effective. Moreover, you did not consider a retrospective review and risk assessment to evaluate the potential impact of the inadequate documentation and lack of access controls, along with their associated risks, on the validity of your test results.In response to this letter, provide:A complete assessment of documentation systems used throughout your laboratory operations to determine where documentation practices are insufficient. Include a detailed corrective action and preventive action plan that comprehensively remediates your firm’s documentation practices to ensure you retain attributable, legible, complete, original, accurate, contemporaneous records throughout your operation.A risk assessment summarizing the potential impact of inadequate documentation on product quality, and a commitment to notify customers of any deficiencies.A risk assessment summarizing the potential impact of lack of access controls of the computers and NMR equipment on product quality, and a commitment to notify customers of any deficiencies.See FDA’s guidance documentData Integrity and Compliance With Drug CGMPfor guidance on establishing and following CGMP compliant data integrity practices at https://www.fda.gov/media/119267/download.2. Failure of your quality unit to ensure that drugs are appropriately tested and the results are reported.You failed to establish a quality unit (QU), including defining responsibilities and procedures applicable to a QU. Additionally, when asked during the inspection whether you track any deviations and laboratory errors, you responded that you only provide testing results. Your laboratory director stated that the firm is not involved in CGMP activities, however, your customers used your data for CGMP purposes.Without an adequate QU and quality system in place, there is inadequate assurance that controls are implemented to ensure that your CGMP testing operations are performing in a state of control.In your response, you state that you established a quality department and provided supporting documentation, including standard operating procedures. Your response is inadequate as your procedures appear to lack sufficient detail and comprehensive coverage of all the systems supporting your CGMP testing operations.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: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 the laboratory record for each sample and its related information before the QU disposition decision.o Oversight and approval of investigations and discharging of all other QU duties to ensure validity of the laboratory test results without having negative impact on identity, strength, quality, and purity of your customers’ drug products.A comprehensive, independent assessment of your change management system. This assessment should include, but not be limited to, your procedures to ensure changes, such as changes to or deviations from a validated test method, are justified, reviewed, investigated, and approved by your QU. Your change management program should also include provisions for determining change effectiveness.An adequate QU overseeing all elements of CGMP is necessary to consistently ensure drug product quality. Your firm’s quality systems are inadequate. See FDA’s current thinking on quality systems in the FDA guidance documentQuality Systems Approach to Pharmaceutical CGMP Regulationsat https://www.fda.gov/media/71023/download for help in implementing quality systems and risk management approaches.Drug Testing CeasedWe acknowledge your commitment to cease all drug testing services for the U.S. market. In response to this letter, clarify whether and when you intend to resume drug testing for the U.S. market at this facility in the future.If you plan to resume any CGMP operations regulated under the FD&C Act, notify this office before resuming your operations. You are responsible for resolving all deficiencies and systemic flaws to ensure your firm is capable of ongoing CGMP compliance.Responsibilities of a Contract Testing LabFDA considers contractors as extensions of the manufacturer’s own facility. Your failure to comply with CGMP may affect the quality, safety, and efficacy of the drugs you test for your customers. It is essential that you understand your responsibility to operate in full compliance with CGMP, and that you inform all your customers of any out-of-specification results or significant problems encountered during the testing of these drugs.CGMP Consultant RecommendedBased upon the nature of the deviations we identified at your firm, you should engage a consultant qualified to evaluate your operations to assist your firm in meeting CGMP requirements.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.ConclusionCorrect any deviations promptly. FDA may withhold approval of new applications or supplements listing your firm as a manufacturer until any deviations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to any deviations.Failure to address any deviations may also result in the FDA refusing admission of articles manufactured by your customers and tested at the Center for Instrumental Analysis of China Pharmaceutical University, at Zhongyang Road, No. 24 Tongjiaxing Road, Nanjing, Jiangsu, 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 deviations 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 3005057567 and ATTN: Emily Wu.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and Research

Delivery Method:VIA Electronic MailReference #:320-25-33Product:DrugsRecipient:Mr. Alan XuGeneral ManagerImperial Palace Commodity -Dongguan- Co., Ltd.No. 523 1st Liudong RoadChanglong VillageHuangjiang TownDongguan ShiGuangdong Sheng,523750ChinaIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter320-25-33January 27, 2025Dear Mr. Xu: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 March 4, 2024 request, and subsequent requests, 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, Imperial Palace Commodity (Dongguan) Co., Ltd., FEI 3014838570, at No. 523 1st Liudong Road, Changlong Village, Huangjiang Town, Dongguang, Guangdong 523750, China.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 responses 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 FD&C Act (21 U.S.C. 351(a)(2)(B)).704(a)(4) Request for Records and Related CGMP ViolationsFollowing 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 test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality. 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 alcohol wipes. Based on the records and information you provided, you did not demonstrate that you have adequately tested incoming components used in the manufacture of your drug products. For example, you failed to conduct adequate identity testing on your incoming components. Additionally, your firm relied on the certificates of analysis (COAs) from your suppliers and failed to establish the reliability of each of your suppliers’ COA for component specifications and characteristics at appropriate intervals.GlycerinInformation provided indicates that you failed to demonstrate that you adequately test each shipment of each lot of glycerin for identity, a component at higher risk for diethylene glycol (DEG) and ethylene glycol (EG) contamination. We note that glycerin is an ingredient used in your alcohol wipe drug products. Identity testing of glycerin, along with other high-risk drug components1, includes a limit test in the United States Pharmacopeia (USP) to ensure that the component meets the relevant safety limits for levels of DEG or EG. Because you did not perform identity testing on each shipment of each glycerin lot using the USP identification tests that detects these hazardous impurities, you failed to assure the acceptability of this component for use in the manufacture of your drug products.The use of ingredients contaminated with DEG or EG has resulted in various lethal poisoning incidents in humans worldwide. See FDA’s guidance documentTesting of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated Starch Hydrolysate, Sorbitol Solution, and Other High-Risk Drug Components for Diethylene Glycol and Ethylene Glycolto help you meet the CGMP requirements when manufacturing drugs containing ingredients at high-risk for DEG or EG contamination at https://www.fda.gov/media/167974/download.EthanolYou also failed to adequately test your incoming component, ethanol, used as an active ingredient in your alcohol wipes, for methanol. The use of ethanol contaminated with methanol has resulted in various lethal poisoning incidents in humans worldwide. See FDA’s guidance documentPolicy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanolto help you meet the CGMP requirements when manufacturing drugs containing ethanol at https://www.fda.gov/media/173005/download.Without adequate testing, you do not have scientific evidence that your incoming components conform to appropriate specifications before use in the manufacture of your drug products.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)).Process ValidationBased on the records and information you provided, you did not demonstrate that you have adequately validated the manufacturing process for your alcohol wipe drug products. For example, the records you provided to demonstrate your process validation for your drug products, included only reports of analytical test results.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.Water System ValidationYour firm uses water as a component in your drug products. You have not demonstrated that your firm’s water system has been adequately designed and validated for its intended use. For example, your response states that your water system is qualified only for(b)(4)water. In addition, your(b)(4)water validation report did not include testing results for total organic carbon. Your firm has not demonstrated that the water is suitable for use and meets the USP(b)(4)Water monograph specifications.3. Your firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity (21 CFR 211.160(b)).Based on the records and information you provided, you did not demonstrate that you used an appropriate test method for microbiological testing as part of your stability program. For example, the records you provided for your stability program identified your microbiological testing method as “Antibacterial efficacy test-refer to USP 40 51>.” You reported results for “total aerobic microbial count,” “coliform bacteria,” and “fungi,” as well as other specified microorganisms, but your results reflect that your methods are not consistent withUSP Antimicrobial Effectiveness Testing. The methodology described in USP is intended to demonstrate the effectiveness of added microbial preservatives; however, your response states that your drug products do not contain preservatives.Without appropriate test methods, you do not have scientific evidence to support whether your drug products meet their established microbiological specifications through their labeled expiry.4. Your firm failed to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products (21 CFR 211.22(a)).The records and information you provided demonstrated that your quality unit (QU) did not effectively exercise its responsibilities to oversee the quality of your drug manufacturing operations. For example, your QU did not adequately exercise its authority over the establishment of controls in your Materials System and Laboratory Control System.Your QU is responsible for fully exercising its authority and responsibilities. FDA is concerned that your QU may not be conducting appropriate oversight regarding CGMP operations. 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/media/71023/download.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 corrective actions and preventive actions.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 products offered for import into the United States from your firm on Import Alert 66-40 on January 23, 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 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 Imperial Palace Commodity Dongguan Co., Ltd., at No. 523 1st Liudong Road, Changlong Village, Huangjiang Town, Dongguan, Guangdong 523750, China, 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.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 3014838570 and ATTN: Joel Hustedt.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and ResearchCC:Registered U.S. AgentPro Medical Supplies, Inc.Mr. Jake SztejmanEmail: Jake.Sztejman@outlook.com_________________________1Components with higher risk of DEG or EG contamination compared to other drug components.

Delivery Method:VIA UPSReference #:320-25-34Product:DrugsRecipient:Fang YongliangManagerShantou Kangjie Daily Chemical Industry Co., LtdKangjie Company, Xiangang RoadSimapu TownShantou ShiGuangdong Sheng,515000ChinaIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter320-25-34January 28, 2025Dear Fang Yongliang: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 March 25, 2024, request 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, Shantou Kangjie Daily Chemical Industry Co., Ltd, FEI: 3016825286, at Kangjie Company, Xiangang Road; Simapu Town, Shantou, Guangdong, China.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 (21 CFR 211.84(d)(1)).You manufacture OTC drug products including hand sanitizer. Based on the records and information you provided, you have not demonstrated that you are testing incoming raw materials used to manufacture your drug products to determine their identity.In response to our request, you stated that you do not perform identity testing on each shipment of each lot of drug ingredients (components) before they are released for use in manufacturing.Without adequate testing, you do not have scientific evidence that components conform to appropriate specifications prior to use in the manufacture of your drug products. As a manufacturer, you have a responsibility to sample, test, and examine drug components before use in production to assure adequate quality.EthanolYou manufacture drugs that contain ethanol. Your response to our records and other information indicate that you do not test your incoming ethanol, used as an active ingredient, for methanol. The use of ethanol contaminated with methanol has resulted in various lethal poisoning incidents in humans worldwide. See FDA’s guidance documentPolicy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanolat: https://www.fda.gov/media/173005/download.In response to this letter, provide the following: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 certificates of analysis (COAs) 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 re-validation. In addition, include a commitment to always conduct at least one specific identity test for each incoming component lot.A summary of results obtained from testing all components to evaluate the reliability of the COA from each component manufacturer. Include your SOP that describes this COA validation program.A summary of your program for qualifying and overseeing contract facilities that test the drug products you manufacture.2. Your firm failed to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products (21 CFR 211.22(a)).The records and information you provided demonstrate that your quality unit (QU) did not effectively exercise its responsibilities to oversee the quality of your drug manufacturing operations. Specifically, in your response, you noted that you do not have a QU.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/media/71023/download.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.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 corrective actions and preventive actions 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 products offered for import into the United States from your firm on Import Alert 66-40 on January 23, 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 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 Shantou Kangjie Daily Chemical Industry Co., Ltd, at Kangjie Company, Xiangang Road; Simapu Town, Shantou, Guangdong, 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 3016825286 and ATTN: CDR Frank Verni.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and Research

Delivery Method:VIA Electronic MailProduct:DrugsRecipient:Jason McGuireSenior Vice President, OperationsFagron Compounding Services, LLC dba Fagron Sterile Service8710 East 34th Street NorthWichita,KS67226-2636United StatesIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERWL # 69886112/19/2024Dear Mr. McGuire: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 October 2, 2015, and most recently on October 18, 2024. From June 18 to June 28, 2024, an FDA investigator inspected your facility, Fagron Compounding Services, LLC dba Fagron Sterile Services, located at 8710 East 34th Street North, Wichita, KS 67226. During the inspection, the investigator collected evidence 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 June 28, 2024. FDA acknowledges receipt of your facility’s responses, dated July 19, 2024, August 30, 2024, September 27, 2024, and October 25, 2024. FDA further acknowledges that on August 15, 2024, your firm initiated a voluntary recall of four lots of Lidocaine HCl Injection, 2% due to lack of sterility assurance. 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 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 collected evidence of the following deficiencies with your facility’s drug product labels:1. The drug product label did not include the dosage form. Examples include: Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac 0.5%, 5mL and Fentanyl Citrate 2mcg/mL (100mcg/50mL)/Ropivacaine HCl 0.15% (1.5mg/mL) (75mg/50mL).2. The drug product label did not include the established name of the drug. Examples include: Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac 0.5%, 5mL; Sodium Citrate 4% (40mg/mL) containing Gentamicin 320mcg/mL Injection, 3mL, 5 mL, and 30 mL; and Epinephrine (1mg/mL), Sterile Solution for Injection.3. The drug product label did not include a list of active ingredients identified by established name. Examples include: Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac 0.5%, 5mL; Sodium Citrate 4% (40mg/mL) containing Gentamicin 320mcg/mL Injection, 3mL, 5 mL, and 30 mL; and Epinephrine (1mg/mL), Sterile Solution for Injection.Further, the investigator collected evidence of the following deficiencies with your facility’s container labels:1. The container from which the individual units of the drug are removed for dispensing or for administration did not include directions for use, including, as appropriate, dosage and administration. Examples include: Epinephrine (1mg/mL), Sterile Solution for Injection; Phenol Injection 6% (60 mg/mL), in Sterile Water for Injection, 10 mL in Multi-Dose Vial; Sodium Citrate 4% (40mg/mL) containing Gentamicin 320mcg/mL Injection, 3mL, 5 mL, and 30 mL; and Dexamethasone Sodium Phosphate 10 mg/mL Solution for Injection, 2 mL in Multi-Dose Vial.2. The container from which the individual units of the drug are removed for dispensing or for administration did not include a list of active ingredients identified by established name. Examples include: Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac 0.5%, 5mL; Sodium Citrate 4% (40mg/mL) containing Gentamicin 320mcg/mL Injection, 3mL, 5 mL, and 30 mL; and Epinephrine (1mg/mL), Sterile Solution for Injection.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 observed that.1. You did not perform adequate product evaluation and take appropriate corrective action after microbial contamination was recovered within the ISO 5 aseptic processing area.2. Your firm produced drug products while construction was underway without adequate controls to prevent contamination of the product environment and products.The FDA investigator also noted CGMP violations at your facility, that caused your drug products 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 maintain the buildings used in the manufacture, processing, packing, or holding of a drug product in a clean and sanitary condition (21 CFR 211.56(a)).3. 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 adulterated.Unapproved 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 responses to the Form FDA 483. We acknowledge your firm’s recall of four lots of Lidocaine HCl Injection, 2% due to lack of sterility assurance.Some of your corrective actions appear adequate; however, we cannot fully evaluate the adequacy of the following corrective actions due to lack of adequate supporting documentation. Pertaining to theChaetomium globosumrecovery referenced, you stated the operator “was in training at the time of the recovery.” The investigation into the recovery, DEV-2024-0174, states the operator, “was not fully trained” and “left unsupervised by a qualified trainer, which is a deviation” from procedure. Your firm identified this deviation after reviewing footage of batch(b)(4). However, upon discovering this deviation, your investigation did not expand to other lots produced or operations conducted by the “not fully trained” operator.Some of your corrective actions appear deficient. You stated in your response, “For the personnel samples, the samples were taken after the completion of the(b)(4)process, prior to removal of waste and disinfection/sanitization of the ISO 5 hood and equipment. In review of the batch record, the operators for Succinylcholine lot(b)(4), Rocuronium lot(b)(4)and Lidocaine lot(b)(4)had performed staging, support and(b)(4)activities prior to taking the glove samples. This included sanitizing materials into the hood, removing filled bags, insertion of sterile needle into the bag ports and batch record documentation. None of these activities impacted the filling of the child batches as each child batch did not have a recovery and sterility testing for each passed.” We disagree with your assessment. The operator was involved in critical process parameters, including(b)(4)of the parent batch. This parent batch was used to fill four child batches. The child batches were not(b)(4). We acknowledge your recall of child batches of the parent lot: Lidocaine HCl 2%, Lot#(b)(4), within expiry on August 9, 2024.Please note, microbial contamination, when present, is not uniformly distributed within a batch; therefore, it may not be identified in a sterility test. Compounding facilities producing drug products intended to be sterile under insanitary conditions should not rely upon or cite a passing sterility test result as an indication of product sterility.We acknowledge your commitments in response to our concerns noted with your upcoming facility expansion. During the next FDA inspection, we will assess the potential impact of the upcoming planned construction activities on the quality of sterile drug products that were produced and distributed to patients.In addition to the issues discussed above, you should note that CGMP requires the implementation of quality oversight and controls over the manufacture of drugs, including the safety of raw materials, materials used in drug manufacturing, and finished drug products. See section 501 of the FDCA. If you choose to contract with a laboratory to perform some functions required by CGMP, it is essential that you select a qualified contractor and that you maintain sufficient oversight of the contractor’s operations to ensure that it is fully CGMP compliant. Regardless of whether you rely on a contract facility, you are responsible for assuring that drugs you produce are neither adulterated nor misbranded. [See21 CFR 210.1(b), 21 CFR 200.10(b).]In addition, regarding issues related to the conditions of section 503B of the FDCA, some of your corrective actions appear adequate: You have initiated CAPA-2024-0105 and CAPA-2024-0106 to address label issues concerning dosage form, established name of the drug and directions for use. However, no corrective actions have been provided to the agency to address label issues concerning a list of active ingredients identified by established name.Should you continue to compound and distribute drug products that do not meet the conditions of section 503B, the compounding and distribution of your drugs would be subject to the new drug approval requirement, the requirement to label drug products with adequate directions for use, and the Drug Supply Chain Security Act requirements.FDA strongly recommends that your management undertake a comprehensive assessment of operations, including facility design, procedures, personnel, processes, maintenance, materials, and systems. In particular, this review should assess your aseptic processing operations. A third-party consultant with relevant sterile drug manufacturing expertise should assist you in conducting this comprehensive evaluation.E. ConclusionThe violations cited in this letter are not intended to be an all-inclusive statement of violations 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. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.You should take prompt action to address any violations. 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 notify this office in writing of the specific steps that 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.Your response and any questions regarding the contents of this letter should be sent to compoundinginspections@fda.hhs.gov. In your response, refer to the Warning Letter Number above (#698861) and include a subject line that clearly identifies the submission as a Response to Warning Letter.Sincerely,/S/F. Gail Bormel, JD, RPhDirectorOffice of Compounding Quality and ComplianceOffice of ComplianceCenter for Drug Evaluation and Research_______________1See Pub. L. No. 113-54, § 102(a), 127 Stat. 587, 587-588 (2013).2We remind you that there are conditions, other than those discussed in this letter, that must be satisfied to qualify for the exemptions in section 503B of the FDCA.3The specific products made by your firm 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.4Your compounded drug products are not exempted from the requirements of section 502(f)(1) of the FDCA by regulations issued by the FDA (see, e.g., 21 CFR 201.115).

Delivery Method:Via Electronic Mail - Delivery and Read Receipt RequestedReference #:320-25-30Product:DrugsRecipient:Mr. Arif VazirallyExecutive ChairmanGlobal Calcium Pvt. LimitedNo. 882, 6th Cross, 6th BlockKoramangalaBengaluru560095IndiaIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter320-25-30January 16, 2025Dear Mr. Vazirally:The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Global Calcium Pvt. Limited, FEI 3004094136, at Bangalore - Hosur Highway, 125/126, Sipcot Industrial Complex, Hosur, Tamil Nadu, India 635126, from July 29 to August 2, 2024.This warning letter summarizes significant deviations from Current Good Manufacturing Practice (CGMP) for active pharmaceutical ingredients (APIs).Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your APIs 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).We reviewed your August 23, 2024 response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence.During our inspection, our investigators observed specific deviations including, but not limited to, the following.1. Failure of your quality unit to prepare, review, and approve documents related to the manufacturing of APIs in accordance with written procedures.You provided production records for two different APIs that showed manufacturing activities occurred simultaneously on the same equipment. For example, your batch records and equipment logbooks show the same equipment including, but not limited to,(b)(4)were used at the same time to manufacture(b)(4)USP and(b)(4)USP.Additionally, you deleted multiple electronic records during the inspection. For example, on the initial morning of the inspection, investigators observed Microsoft Excel documents on a desktop computer in the Plant(b)(4)production office including, but not limited to, “(b)(4)Cleaning validation samples,” “(b)(4)Production Details-2024,” “Plant-(b)(4)production Report Jun-2024,” and “Planning June-2024.” On the second day, investigators returned to the production office to review these files. However, all files had been deleted and could not be recovered during the inspection. Without access to the files, the investigators were unable to determine their purpose and adequately evaluate your adherence to CGMP.In your response, you acknowledge your production head directed the creation of falsified manufacturing records to misrepresent API production activities so incentives could be claimed regarding production in plant(b)(4). Additionally, you state a lack of training and other factors resulted in deficient documentation control, then explain you have revised your SOP for document issuance and control. You also state Microsoft Excel files were deleted to “avoid unwanted conversation” with the investigators, and add the computers in question are for “personal use to record day to day activities” so there is no impact on product quality. We also acknowledge you performed a product quality impact assessment.Your response is inadequate. Your product quality impact assessment relies, in part, on data generated by your facility’s deficient documentation practices, and therefore is inherently unreliable. Furthermore, you do not adequately evaluate how widespread the practice of record fabrication extends throughout your facility, and you do not share in sufficient detail how you will prevent, detect, and investigate non-contemporaneously prepared records. You also do not adequately explain which, if any records were legitimate and pertain to actual product produced on your equipment. Considering your response states you created records that “falsely attributed” production activities to claim incentives, FDA is concerned about the adequacy of your remediation efforts given you have not sufficiently reconciled all CGMP records.Data Integrity RemediationYour quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture. See FDA’s guidance documentData Integrity and Compliance With Drug CGMPfor guidance on establishing and following CGMP compliant data integrity practices at https://www.fda.gov/media/119267/download.We acknowledge you are using an independent third-party consultant to audit your operation and assist you in meeting FDA requirements.In response to this letter, provide:A full reconciliation of all APIs manufactured at your facility intended for the US market over the past 3 years, including:o Name and lot numbers of API manufactured and released.o Plant or building identification where the API was made, including date of manufacture.o All API or intermediates received and packaged for further distribution from any or your manufacturing plants in the current location.o Determination if singular or multiple batch records exist, or if records are incomplete.o For each instance of CGMP record anomalies identified by an independent third party, a description of the issue, as well as a detailed root cause and corrective action plan.o Status of each employee involved in record fabrication as described above and as part of your investigation, and whether they are currently employed or still performing CGMP functions at your company.A comprehensive investigation into the extent of the inaccuracies in data records and reporting. Your investigation should include:o A detailed investigation protocol and methodology; a summary of all laboratories, manufacturing operations, and systems to be covered by the assessment; and a justification for any part of your operation that you propose to exclude.o Interviews of current and former employees to identify the nature, scope, and root cause of data inaccuracies. We recommend that these interviews be conducted by a qualified third party.o An assessment of the extent of data integrity deficiencies at your facility. Identify omissions, alterations, deletions, record destruction, non-contemporaneous record completion, and other deficiencies. Describe all parts of your facility’s operations in which you discovered data integrity lapses.o A comprehensive retrospective evaluation of the nature of the manufacturing data integrity deficiencies. We recommend that a qualified third party with specific expertise in the area where potential breaches were identified should evaluate all data integrity lapses.A current risk assessment of the potential effects of the observed failures on the quality of your drugs. Your assessment should include analyses of the risks to patients caused by the release of drugs affected by a lapse of data integrity and analyses of the risks posed by ongoing operations.A management strategy for your firm that includes the details of your global corrective action and preventive action (CAPA) plan. Your strategy should include:o A detailed corrective action plan that describes how you intend to ensure the reliability and completeness of all the data you generate including analytical data, manufacturing records, and all data submitted to FDA.o A comprehensive description of the root causes of your data integrity lapses including evidence that the scope and depth of the current action plan is commensurate with the findings of the investigation and risk assessment. Indicate whether individuals responsible for data integrity lapses remain able to influence CGMP-related or drug application data at your firm.o Interim measures describing the actions you have taken or will take to protect patients and to ensure the quality of your drugs, such as notifying your customers, recalling product, conducting additional testing, adding lots to your stability programs to assure stability, drug application actions, and enhanced complaint monitoring.o Long-term measures describing any remediation efforts and enhancements to procedures, processes, methods, controls, systems, management oversight, and human resources (e.g., training, staffing improvements) designed to ensure the integrity of your company’s data.o A commitment to have a qualified consultant conduct extensive annual audits, for at least 2 years, to assist in evaluating CAPA effectiveness after you have executed your data integrity remediation protocol.o Inform FDA if you will be hiring a Chief Integrity Officer who is fully empowered to receive anonymous complaints from employees reporting data integrity concerns and with the authority to ensure any potential breach is promptly investigated (by independent quality assurance function, along with expertise from outside entities whenever needed).o A status report for any of the above activities already underway or completed.2. Failure to properly maintain buildings and facilities used in the manufacture of APIs.You failed to maintain your facility in an acceptable state of repair. For example, investigators observed a room with(b)(4)liquid in a floor cavity surrounding the exit pipe of a(b)(4). A similar liquid was dripping from a ceiling pipe junction in the(b)(4)area below this room. The liquid was dripping onto processing equipment labeled as clean and ready for use.It is essential your facility is in a good state of repair, and sanitary conditions are maintained to ensure ongoing suitability for drug manufacturing.In your response, you state no production activities were taking place in the(b)(4)area, as it was partially shut down to make various upgrades, and you state the damaged flooring has since been repaired. You also state personnel did not display proper signage in the area, as required by your procedure, and a change control had been initiated. Additionally, your deviation report submitted with your response states personnel were not aware of ongoing maintenance activities in Plant(b)(4).Your response is inadequate. You do not sufficiently address potential contamination of previously manufactured lots caused by leaks from the flooring. During the inspection, no information was provided to support a partial shutdown, or that a change control was initiated as indicated in your response. Additionally, you do not adequately evaluate the potential quality impact to previously manufactured lots produced during maintenance shutdowns, and thus outside your standard manufacturing controls. Furthermore, based on your documentation deficiencies, it is unclear whether you manufactured lots of API during partial shutdown activities. You also lack evidence you comprehensively evaluated the state of repair throughout your entire facility.In response to this letter, provide:Your CAPA 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.A comprehensive evaluation and risk assessment of lots that may have been impacted by leaks from damaged flooring and other facility deficiencies.A list of lots produced on equipment, or in areas, that were in a shutdown status.Your training records and updated procedures to show your staff is aware of procedures related to maintenance and shutdown activities.3. Failure to establish an impurity profile for identified and unidentified impurities.You failed to conduct a comprehensive evaluation of your manufacturing processes to identify all potential impurities. For example, the impurity profile you provided for(b)(4)USP, only listed those impurities described in the United States Pharmacopeia (USP), without considering your unique processes and materials to describe additional impurities in a typical lot. Furthermore, you failed to sufficiently classify each identified impurity. Our inspection also noted impurities are not monitored during stability studies.In your response, you include impurity profiles and data from forced degradation studies, which you state was provided to investigators on the final day of the inspection. We acknowledge you also include updated impurity profiles with further details completed since the inspection. You also state drug product manufacturers who you supply perform testing of the drug products for impurities, and you have not received any returned APIs due to quality issues.Your response is inadequate. Our inspection found you have received at least two lots of returned product due to quality issues in the last two years. You also received a complaint for one lot of(b)(4)USP that failed the customer’s identity testing. Furthermore, you do not provide a retroactive risk assessment of distributing APIs with incomplete impurity profiles, and you lack evidence that you communicated your updated impurity profiles to your customers who you state test the drug products for impurities. Additionally, your APIs are distributed to(b)(4)who typically do not test components for compliance with quality specifications, including impurity testing.In response to this letter, provide:A retrospective review of all API lots released without appropriate testing for impurities and how that may impact finished drug quality.A plan to address any product quality or patient safety risks for out-of-specification lots of APIs in U.S. distribution, including recalls.Specifications, including test methods, used to release APIs. Your response should address your capability to detect and quantify a wide array of potential impurities or contaminants.Improved procedures for performing a systemic evaluation for identifying impurities and establishing a control strategy from the process development stages.Results from release testing of all lots of(b)(4)USP that remain within the established retest or expiry date.Updated risk assessments for the potential presence of impurities in(b)(4)USP manufactured at your facility. Include your program for ongoing evaluation of impurity profiles for all drugs and starting materials you produce.Identify corrective actions to ensure adequate quality oversight of establishing appropriate impurity and degradant limits for all drugs and starting materials, you produce, using well-studied, scientifically based impurity profiles specific to their own manufacturing processes.CGMP Consultant RecommendedBased upon the nature of the deviations we identified at your firm, you should engage a consultant qualified to evaluate your operations and to assist your firm in meeting CGMP requirements. The qualified consultant should also perform a comprehensive 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.Additional API CGMP GuidanceFDA considers the expectations outlined in ICH Q7 when determining whether API are manufactured in conformance with CGMP. See FDA’s guidance documentQ7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredientsfor guidance regarding CGMP for the manufacture of API at https://www.fda.gov/media/71518/download.ConclusionThe deviations cited in this letter are not intended to be an all-inclusive list of deviations that exist at your facility You are responsible for investigating and determining the causes of any deviations and for preventing their recurrence or the occurrence of other deviations.If you are considering an action that is likely to lead to a disruption in the supply of drugs produced at your facility, FDA requests that you contact CDER’s Drug Shortages Staff immediately, at drugshortages@fda.hhs.gov, so that FDA can work with you on the most effective way to bring your operations into compliance with the law. Contacting the Drug Shortages Staff also allows you to meet any obligations you may have to report discontinuances or interruptions in your drug manufacture under 21 U.S.C. 356C(b). This also allows FDA to consider, as soon as possible, what actions, if any, may be needed to avoid shortages and protect the health of patients who depend on your products.FDA placed products offered for import into the United States from your firm on Import Alert 66-40 on December 20, 2024.Correct any deviations promptly. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any deviations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to any deviations.Failure to address any deviations may also result in the FDA continuing to refuse admission of articles manufactured at Global Calcium Pvt. Limited, Tamil Nadu, 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).We request you email Christina Reyes, Christina.Reyes@fda.hhs.gov, within five days of receipt of this letter to schedule a call with FDA.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 days1. Specify what you have done to address any deviations 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 3004094136 and ATTN: Matthew Jensen.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and Research_______________________________1Under program enhancements for the Generic Drug User Fee Amendments (GDUFA) reauthorization for fiscal years (FYs) 2023-2027, also known as the GDUFA III Commitment Letter, your facility may be eligible for a Post-Warning Letter Meeting to obtain preliminary feedback from FDA on the adequacy and completeness of your corrective action plans.