江西绿尔康医疗器械有限公司报告，由于产品质量不符合产品技术要求等原因，江西绿尔康医疗器械有限公司对其生产的活络贴(注册备案号:赣械注准20162090097)主动召回，召回级别为三级,涉及产品的型号、规格及批次等详细信息见《医疗器械召回事件报告表》。附件：医疗器械召回事件报告表2025-07-23

为加强对中药饮片生产企业的监督管理，保障中药饮片生产质量安全，安徽省药品监督管理局组织对全省中药饮片生产企业自主停产情况进行梳理排查。现将2025年上半年全省中药饮片生产企业自主停产情况予以公布。特此通告。附件：2025年上半年全省自主停产中药饮片生产企业信息表                                  安徽省药品监督管理局                                   2025年7月22日附件2025年上半年全省自主停产中药饮片生产企业信息表序号企业名称生产地址停产范围法定代表人或企业负责人停产类型停产时间1安徽省天和中药材开发有限公司合肥市长丰县双凤工业区金福路3号中药饮片（净制、切制）庄武璋主动报告2022年12月23日2安徽博润药业有限公司合肥市巢湖市烔炀路工业产业园中药饮片(净制、切制、蒸制、煮制、炒制、炙制、煅制、燀制、煨制、制炭、发酵)张小勇未报告但分局在监督检查中发现2025年4月17日3合肥顾公蜂蜜饮片有限责任公司肥西县上派工业聚集区新仓路中药饮片(净制)顾振宇主动报告2025年2月6日4安徽省百萃金方药业有限公司安徽谯城经济开发区药都路与华佗大道交叉口西南角，药都路2022号中药饮片(含毒性饮片，净制、切制、蒸制、炒制、炙制、煅制、制炭、煨制)注：毒性饮片(净制、切制、煮制、炒制)等胡小燕主动报告2024年6月20日5安徽天草堂中药饮片有限公司安徽省亳州市南部新区创业基地B区17号楼A座中药饮片(含毒性饮片，净制、切制、蒸制、炒制、炙制、煅制）注：毒性饮片（净制、切制、煮制、炒制）唐春华主动报告2022年7月21日6亳州市天成中药饮片有限公司亳州市南部新区现代中药产业创业基地B区12栋中药饮片(含毒性饮片，净制、切制、蒸制、煮制、炖制、炒制、炙制、煅制、制炭、燀制）注：毒性饮片（净制、切制、煮制、炒制）张虎主动报告2022年6月21日7安徽同泰药业有限公司亳州市经济开发区颗粒剂（含中药提取），中药饮片（净制、切制、蒸制、炒制、煅制）杨杰主动报告2023年4月21日8安徽颐生堂中药饮片有限公司亳州市涡阳县义门镇真源南路中药饮片(含毒性饮片，净制、切制、炒制、炙制、蒸制、煅制）注：毒性饮片（净制、切制、煮制、炙制）李志强主动报告2022年2月21日9安徽盛源百草堂中药饮片科技有限公司亳州市现代中药产业创业基地B区提取车间12栋中药饮片（含毒性饮片，净制、切制、蒸制、煮制、燀制、炒制、炙制、制炭、煅制）注：毒性饮片（净制、煮制、切制、炙制）张傲主动报告2022年12月27日10安徽源和堂中药饮片有限责任公司涡阳县义门镇药材街1号中药饮片(含毒性饮片，直接口服饮片)袁学才主动报告2021年7月7日11太安堂（亳州）中药饮片有限公司安徽省亳州市经开区蔷薇路999号中药饮片(净制、切制、蒸制、炒制、炙制、煅制）（含毒性饮片，直接口服饮片）周建设主动报告2024年6月5日12亳州吉贝尔现代中药饮片科技有限公司亳州市南部新区现代中药产业创业基地B区17号楼B座中药饮片（净制、切制、蒸制、炒制、炙制、煅制）韩崇应主动报告2021年4月10日13安徽广印堂制药有限公司亳州市国际中医药高科技园区1栋1号中药饮片（净制、切制、炒制、炙制、蒸制）高广印主动报告2021年3月10日14亳州亳药堂药业有限公司亳州经济开发区银杏路1188号中药饮片（净制、切制、蒸制、煮制、炒制、炙制、煅制、煨制、燀制、制炭）， 毒性饮片（净制、切制、煮制、炒制、炙制），颗粒剂刘桂莲主动报告2022年9月10日15长白山制药（亳州）产业园有限公司安徽谯城经济开发区银杏路333号中药饮片（净制、切制、蒸制、煮制、炒制、炙制、煅制、煨制、制炭）于雷主动报告2024年7月2日16天津达仁堂（亳州）中药饮片有限公司安徽省亳州市谯城区经济开发区养生大道北侧、华佗大道西侧中药饮片（含毒性饮片，直接口服饮片）李少晶主动报告2025年3月1日17安徽汉盛药业有限公司亳州市谯城区亳芜现代产业园区魏武大道以东、合欢路以北中药饮片（含毒性饮片，直接口服饮片）洪福川主动报告2025年4月18日18亳州臻鸿中药饮片有限公司安徽省亳州市谯城区夏侯渊路18号毒性饮片（净制、切制、煮制、炒制、炙制）郭长青主动报告2025年7月7日29阜阳白云山和记黄埔中药科技有限公司安徽省阜阳市开发区经三路789号中药饮片（净制、切制、蒸制、煮制、燀制、制炭、炒制、炙制、煅制）管成忠主动报告2021年1月1日20安徽润通药业有限公司安徽省阜阳市太和县城关镇工业园区东区兴业路1号中药饮片（净制、切制、蒸制、炒制、炙制、煅制）荆敏主动报告2021年1月1日21安徽健欣药业有限公司太和县经济开发区裕民东路路北侧和六路西侧中药饮片（含毒性饮片，净制、切制、蒸制、炒制、炙制、煅制）注：毒性饮片（净制、切制、蒸制、煮制）李梓涵主动报告2023年5月4日22精诚徽药药业股份有限公司蚌埠市长青南路36号中药饮片(含直接口服饮片，净制、切制、蒸制、煮制、燀制、炒制、炙制、煅制)孙宝主动报告2020年8月1日23蚌埠火鹤制药股份有限公司蚌埠市兴华路189号中药饮片(净制、切制)陈晓明主动报告2020年11月1日24九华华源药业股份有限公司安徽省滁州市琅琊区创业路211号中药饮片(净制、切制、蒸制、煮制、炒制、炙制、燀制)郑卫兵主动报告2020年6月28日25霍山衡济堂中药饮片有限公司霍山县黑石渡镇工业集中区中药饮片（净制、切制）郭昌会主动报告2021年10月21日26中国中药霍山石斛科技有限公司安徽省霍山县高桥湾现代产业园中药饮片（净制、切制）刘道章主动报告2024年5月15日27安徽右旋龙脑生物科技有限公司淮南市田家庵区史院乡政府西北200米中药饮片邹亲成主动报告2022年2月16日28国药集团精方（安徽）药业股份有限公司安徽省宣城市宣水路16号中药饮片（含直接口服饮片）左言东主动报告2022年10月1日29安徽新泰药业有限公司安徽省池州市青阳县乔木乡工业集中区中药饮片（净制、切制、蒸制、炒制、炙制、煅制、燀制、制炭），毒性饮片（净制、切制、煮制）郭义红主动报告2022年4月1日

行政相对人名称江苏百荟聚通制药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913203123312518324工商注册号组织机构代码税务登记号事业单位证书号社会组织登记证号法定代表人张庆鲜法定代表人证件类型法定代表人证件号码证件类型证件号码行政处罚决定书文号苏药监（徐）处罚〔2025〕2号违法行为类型未经批准擅自变更许可事项等违法事实未经批准擅自变更许可事项等处罚依据《中华人民共和国药品管理法》第一百一十七条、《中华人民共和国药品管理法》第一百二十六条、《药品生产监督管理办法》第六十八条第一项处罚类别罚款;没收违法所得、没收非法财物处罚内容1.警告；2.没收违法生产的药品和违法所得4845.04元；3.罚款20万元。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）1.427804暂扣或吊销证照名称及编号处罚决定日期2025/07/22处罚有效期2026/01/21公示截止期2026/07/22处罚机关江苏省药品监督管理局处罚机关统一社会信用代码11320000014000394R数据来源单位江苏省药品监督管理局数据来源单位统一社会信用代码11320000014000394R备注

全省各级药品监督管理部门深入贯彻落实党中央、国务院关于加强药品安全的一系列决策部署，持续加强药品全链条、全生命周期监督管理，严厉打击违法犯罪行为，依法查处了一批违法违规案件，切实保障人民群众身体健康和用药安全。现将四起违法违规案件典型案例公布如下。一、陕西某医药集团有限公司违反《药品经营质量管理规范》案。2024年5月，陕西省药监局执法人员在许可检查中发现，陕西某医药集团有限公司存在将国家有特殊管理要求的药品销售给《药品经营许可证》已注销的药店的行为，该行为违反《药品经营质量管理规范》第十七条、第八十九条、第九十三条、《药品管理法》第五十三条第一款之规定，依据《药品管理法》第一百二十六条之规定，给予该公司罚款、责令停业整顿的行政处罚；对涉案相关责任人李某、路某、韩某以没收违法行为发生期间自本单位所获收入及罚款，并对李某处以2年禁止从事药品生产经营活动的行政处罚。二、西安某医药有限公司第三分公司销售劣药案。2025　年　4　月，西安市长安区市场监管局执法人员对西安某医药有限公司第三分公司进行现场检查，经查，该公司存在销售过期药品的行为，该公司违反了《中华人民共和国药品管理法》第九十八条第三款之规定，依据《中华人民共和国药品管理法》第一百一十七条第一款之规定，给予该公司没收涉案产品及罚款的行政处罚。三、宝鸡某医疗用品有限公司生产不符合技术要求的医疗器械案。2024年12月，陕西省药监局执法人员根据医疗器械省抽不合格报告，对宝鸡某医疗用品有限公司进行检查时发现，该公司存在生产不符合经注册的产品技术要求和强制性行业标准的医疗器械的行为，违反了《医疗器械监督管理条例》第三十五条第一款的规定，依据《医疗器械监督管理条例》第八十六条第一款第一项之规定，给予该公司没收召回涉案产品及罚款的行政处罚。四、安康市汉滨区某美发用品店经营标签不符合规定及不符合注册资料载明技术要求化妆品案。2025年1月，安康市市场监管局根据化妆品省抽不合格报告，对安康市汉滨区某美发用品店现场核查发现，该店存在经营标签不符合规定及不符合注册资料载明技术要求的化妆品，其行为违反了《化妆品监督管理条例》第三十六条第（二）项、第（五）项、第三十八条、第六十条第一款第（二）项之规定，依据《化妆品监督管理条例》第六十条第一款及第一款第（二）项、第六十一条第二款、第六十二条第一款及第一款第（二）项之规定，给予当事人警告、没收违法所得、没收涉案产品及罚款的行政处罚。

Delivery Method:VIA UNITED PARCEL SERVICE SIGNATURE REQUIREDReference #:CBER 25-668840Product:BiologicsRecipient:Timothy LoweOwnerO3UV, LLC11968 Sweetwater DriveGrand Ledge,MI48837-8101United StatesIssuing Office:Center for Biologics Evaluation and Research (CBER)United StatesWARNING LETTERJuly 7, 2025CBER 25-668840Dear Mr. Lowe:The United States Food and Drug Administration (FDA) inspected your facility located at 11968 Sweetwater Drive, Grand Ledge, MI 48837-8101, between August 23, 2023, and August 31, 2023. During the inspection, FDA documented that your firm manufactures autohemotherapy devices (1) Champion Full Spectrum (also included in Champion Full Spectrum: Starter Bundle; UV/Ozone Bundle; UV Automation Bundle; UV Complete Bundle) and (2) EBOO Full Spectrum UV (“your products”). Based on information and records gathered prior to, during, and/or after the inspection, your products are devices under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the “Act” or “FD&C Act”), 21 U.S.C. § 321(h), because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.For example, your products are intended to expose patient’s blood to ozone and ultraviolet light before being returned to the patient intravenously during ozone and ultraviolet (UV) blood irradiation (UBI) therapies or Extracorporeal Blood Oxygenation and Ozonation (EBOO). Your products are intended for use in the treatment of various diseases or conditions, such as autoimmune diseases, cardiovascular disorders, and respiratory diseases. Your products may be purchased through your website at www.o3uv.com. You have distributed your products to healthcare practitioners (e.g., physicians, nurses, etc.) throughout the United States.Unapproved Device ViolationsYour products are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because you do not for these devices have approved applications for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or approved applications for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g). Your products are also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), because you did not timely notify the agency of your intent to begin the introduction or delivery for introduction into interstate commerce for commercial distribution of the devices, as required by section 510(k) of the Act, 21 U.S.C. § 360(k). For a device requiring premarket approval, the notification required by section 510(k) of the Act, 21 U.S.C. § 360(k), is deemed satisfied when a PMA is pending before the agency, 21 CFR 807.81(b)(1)(i).The kind of information you need to submit in order to obtain approval or clearance for your products is described at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm. FDA will evaluate the information you submit and respond as appropriate.UDI ViolationsYour products are misbranded within the meaning of section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that you failed or refused to furnish material or information required by or under section 519 of the Act, 21 U.S.C. § 360i, respecting these devices. In particular, the Unique Device Identification regulations at 21 CFR 830.300(a) and 830.320(b) – both of which were promulgated under section 519 of the Act, among other provisions – require that the labeler of a device submit electronically to FDA’s Global Unique Device Identification Database (GUDID) the information required by 21 CFR part 830, subpart E, for each version or model required to bear a unique device identifier (UDI). FDA has determined that your firm is a “labeler” within the meaning of 21 CFR 830.3 in that your firm causes a label to be applied to a device with the intent that the device will be commercially distributed without any subsequent replacement or modification of the label. FDA has also determined that your firm has also failed to submit to the GUDID any information required by 21 CFR part 830, subpart E, respecting these devices.The failure or refusal to furnish any notification or other material or information required by or under section 519 of the Act, 21 U.S.C. § 360i, also constitutes a prohibited act under section 301(q)(1)(B) of the Act, 21 U.S.C. § 331(q)(1)(B).Failure to Register and ListUnder section 510 of the Act, 21 U.S.C. § 360, manufacturers of devices are required to annually register with FDA. Section 510 of the Act further requires domestic and foreign device establishments to submit their annual establishment registration and device listing information to FDA by electronic means (section 510(p) of the Act, 21 U.S.C. § 360(p)) during the period beginning October 1 and ending December 31 of each year. Our records indicate that your firm has not fulfilled annual registration and listing requirements for fiscal year 2025 for your products. As a result, your products are misbranded within the meaning of section 502(o) of the FD&C Act, 21 U.S.C. § 352(o), in that your products were manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act, 21 U.S.C. § 360, and were not included in a list required by section 510(j) of the Act, 21 U.S.C. § 360(j).Your 483 ResponseWe acknowledge receipt of your letter dated September 25, 2023, which provides a response and corrective actions to FDA’s inspectional observations (FDA-483) and some discussion items. We have reviewed the corrective actions outlined in the response and concluded that they are not adequate. For example, your response did not address existing inventory manufactured under the conditions detailed in the FDA-483 or your continued manufacturing, marketing, and distribution of your products for use in the treatment of a host of medical conditions without authorization. Furthermore, you provided no detail regarding when you plan to implement the various procedures you stated you would develop.Additional ConcernsFDA has significant concerns regarding your compliance with current good manufacturing practice (cGMP) requirements at section 501(h) of the Act, 21 U.S.C. § 351(h), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation were not in conformity with the cGMP requirements of the Quality System Regulation found at 21 CFR part 820 at the time of our 2023 inspection. For example, at the time of this inspection, you failed to comply with the following requirements:1. Failure to establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met, as required by 21 CFR 820.30(a)(1).Specifically, your firm had no design control procedures in place to control the design of devices. From January 1, 2022, to August 21, 2023, your firm distributed(b)(4)Champion Full Spectrum (Champion Full Spectrum UV Starter Bundle, Champion Full Spectrum UV/Ozone Bundle, Champion Full Spectrum UV Automation Bundle, Champion Full Spectrum UV Complete Bundle included) and(b)(4)EBOO Full Spectrum UV devices, which were not developed under any design controls.2. Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a).Specifically, your firm had no complaint procedure in place to receive, review, and evaluate complaints.3. Failure to establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements, as required by 21 CFR 820.50.Specifically, your firm had no procedures in place to ensure that all products purchased from suppliers conform to specified requirements. Your firm purchased “ABLE® H-200 High Flux Polyethersulfone Disposable Haemodialysers” (i.e., hemodialyzer filters) sold as part of your 100 Pack EBOO Full Spectrum Kit and EBOO Full Spectrum UV. In addition, your firm purchased Hedy Vet Infusion Pumps sold solo or as a part of bundles (Champion Full Spectrum UV Automation Bundle and Champion Full Spectrum UV Complete Bundle). You did not evaluate these suppliers of these products; you did not establish the requirements, including quality requirements that must be met; and you did not establish purchasing data which includes, where possible, an agreement that the supplier, contractor, and consultants agree to notify the manufacturer of changes in the product or services.4. Failure to establish and maintain procedures for implementing corrective and preventative action (CAPA), as required by 21 CFR 820.100(a).Specifically, your firm had no corrective and preventive action procedures in place to correct and prevent recurrence of identified existing and potential causes of nonconforming product and other quality problems.5. Failure to establish and maintain procedures for acceptance activities, as required by 21 CFR 820.80(a).Specifically,a. Step(b)(4)of your firm’s untitled and uncontrolled work instruction for assembling and testing Champion Full Spectrum UV devices stated, “(b)(4).” The work instruction did not adequately describe the acceptance criteria that must be met. Moreover, you confirmed that test results were not documented.b. Prior to this inspection, your firm did not have a documented work instruction for EBOO Full Spectrum UV device acceptance activities.6. Failure to establish and maintain procedures to ensure that Device History Records (DHR's) for each batch, lot, or unit are maintained, as required by 21 CFR 820.184.Specifically, your firm had no procedure in place to ensure that DHRs for each batch, lot, or unit are maintained.7. Failure to establish procedures for quality audits and conduct such audits to assure that the quality system is in compliance, as required by 21 CFR 820.22.Specifically, your firm had no procedure in place for quality system audits.8. Failure of the management with executive responsibility to review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency according to established procedures, as required by 21 CFR 820.20(c).Specifically, your firm had no procedure in place for management review.Additionally, the inspection revealed that your firm failed to develop, maintain, and implement written MDR procedures as required by 21 CFR 803.17. For example, your firm had no procedure for internal systems that provide for timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements, as required by 21 CFR 803.17(a)(1). A device is deemed to be misbranded under section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), if there was a failure or refusal to furnish any material or information required by or under section 519 of the Act, 21 U.S.C. § 360i, which includes adverse event reports required under 21 CFR part 803, respecting the device.We are also concerned that, at least at the time of our inspection, the labels of your products did not bear a unique device identifier that meets the requirements of 21 CFR part 801, subpart B, and 21 CFR part 830, as required by 21 CFR 801.20(a). A device that fails to bear a UDI as required by the FD&C Act and implementing regulations is misbranded within the meaning of section 502(c) of the Act, 21 U.S.C. § 352(c), because a word, statement, or other information required by or under authority of the Act to appear on the label or labeling of the devices was not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.ConclusionWe request that your firm immediately cease any activities that result in the misbranding or adulteration of your products and that your firm immediately cease committing any acts that are prohibited under the Act. You should take prompt action to address any violations.This letter is not intended to be an all-inclusive list of deficiencies. It is your responsibility to ensure full compliance with all applicable requirements in the FD&C Act, the Public Health Service Act (“PHS Act”), and their implementing regulations.This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address these matters may result in legal action being initiated by FDA without further notice. Such actions may include seizure and/or injunction.We request that you respond in writing within fifteen (15) working days from your receipt of this letter, outlining the specific steps you have taken or plan to take to address any violations and prevent their recurrence. Include any documentation necessary to show that the matters have been addressed. If you cannot address these matters within fifteen (15) working days, please explain the reason for your delay and the timeframe for completion. If you do not believe your products are in violation of the FD&C Act, PHS Act, or applicable regulations, include your reasoning and any supporting information for our consideration.Send your electronic response to CBERDCMRecommendations@fda.hhs.gov. If you have questions regarding this letter, contact the Division of Case Management, CBER at CBERDCMRecommendations@fda.hhs.gov.Sincerely,/S/Melissa J. MendozaDirectorOffice of Compliance and Biologics QualityCenter for Biologics Evaluation and Research

Delivery Method:Via EmailReference #:320-25-92Product:DrugsRecipient:Mr. Umesh GuptaSenior Vice President and Site HeadGlenmark Pharmaceuticals LimitedPlot No. 2, Phase-II, Pharma Zone, SEZPithampur, Indore454774IndiaIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter320-25-92July 11, 2025AMENDED(This letter replaces Warning Letter No. 320-25-92 dated July 11, 2025.)Dear Mr. Gupta:The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Glenmark Pharmaceuticals Limited, FEI 3008565058, located at Phase – II, Sector III, Plot No 2, Pharma Zone, SEZ, Pithampur, Madhya Pradesh, 454774 India, from February 3 to 14, 2025.This warning letter 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).We reviewed your March 10, 2025 response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence.During our inspection, our investigators observed specific violations including, but not limited to, the following.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).A. There were several dissolution failures for potassium chloride extended-release (ER) capsules during stability testing.One of the potential root causes you described was the occasional “(b)(4)” of your incoming active pharmaceutical ingredient (API). You define “(b)(4)” as the “presence of(b)(4)API(b)(4)and(b)(4)API(b)(4)” that “leads to(b)(4)in the particle size distribution.” “(b)(4)” appears to be insufficient to explain the dissolution failures.You have a process control in place to(b)(4)the API for desired particle size prior to(b)(4). You also had both passing and failing drug product batches that used API lots with a “(b)(4)”, and the same API lot number,(b)(4), was noted to be used in both an out-of-specification (OOS) drug product batch and a passing drug product batch.You identified a possible second root cause in a subsequent investigation addendum report, dated January 20, 2025, as a process change from 2021 to adjust the(b)(4)content of your(b)(4)solution from(b)(4)% to(b)(4)%. However, your investigation report did not include sufficient scientific evidence to support this root cause or demonstrate you considered all potassium chloride ER capsule process changes that may impact the dissolution results.We acknowledge that, in June 2024, you recalled all batches of potassium chloride ER capsules within expiry from the U.S. market. However, your investigation was not sufficient to adequately determine root cause(s) of your repeated dissolution failures during long-term stability testing.In your response, you state you reviewed the process changes for the potassium chloride ER capsules since product launch. The response does not sufficiently address all changes that could have contributed to the dissolution failures. Notably, you identify the increase in the(b)(4)content of the(b)(4)solution as a change that was relevant to the dissolution failures. You state that the dissolution failures occurred in batches manufactured after the implementation of this change.However, you do not address other significant changes that could have impacted dissolution. For example, in 2017, you implemented a process change involving the use of a(b)(4)for(b)(4)to replace your(b)(4), along with changing(b)(4)process parameters, such as increasing(b)(4)of the(b)(4)and increasing the(b)(4)of the(b)(4). These process changes may potentially affect drug performance, including the dissolution profile. There is no indication you investigated them adequately as part of your root cause analysis for these dissolution failures.Also, your response explains that(b)(4)particle sizes and non-uniform(b)(4)can lead to poor(b)(4)formation during the(b)(4)process. You indicate this issue can cause(b)(4)formation over time. You performed a research study to assess the impact of different concentrations of the(b)(4)content in the(b)(4)solution onto the particles and storing the product under accelerated conditions. You documented faster dissolution rates when using a higher concentration ((b)(4)%) of(b)(4)solution. While you hypothesized the(b)(4)are associated with dissolution failures, your study did not provide adequate data on(b)(4)morphology, including scanning electron microscope (SEM) analysis used in other aspects of your investigation, to support your conclusion.Your response states the root cause for the dissolution failures is the combined impact of the API particle size distribution and(b)(4)solution(b)(4)content. To evaluate the combination of these variables, you are conducting a design of experiment (DoE) study that evaluates two different particle sizes of your API and(b)(4)different(b)(4)contents of the(b)(4)solution. These engineering batches will then be placed on stability and tested for dissolution. You explain the purpose of this DoE is to verify the assignable cause(s) for your product’s dissolution failures.However, your DoE does not include other process parameters previously determined to be critical to controlling dissolution. Specifically, you had concluded that in-process “generation of(b)(4)is controlled by keeping(b)(4)between(b)(4)at a steady rate during(b)(4),” and “excessive(b)(4)generated during processing leads to uneven(b)(4)in the batch” based on previous engineering studies.B. Your investigations into dissolution failures during stability testing of another drug product,(b)(4)capsule, did not adequately support your root cause. Specifically, your root cause concluded variations in your process parameters, such as the(b)(4)were contributing to the failing dissolution results for this product. You proposed changes to the master batch record parameters for the(b)(4)process as your corrective action and preventative action (CAPA), but did not perform sufficient validation studies to confirm your root cause determination prior to distribution of more batches.Instead, you planned on verifying your CAPA after revising the master batch record. Given the multiple product failures and significant lapse in state of control, process validation studies should have been completed prior to implementation of revised master batch records. You manufactured and distributed several additional batches of(b)(4)capsules prior to suspending manufacturing of this drug product.In your response, you state you manufactured batches of(b)(4)capsules with “stringent process parameters within the validated range” and believed that process validation studies were not needed for “fine tuning” of critical process parameters within the filed drug application range. However, your firm had determined the original parameters to be insufficient to enable a state of control.Per your response, your firm has subsequently initiated further CAPA activities to identify the root cause of the(b)(4)capsule dissolution failures. This CAPA will include experimental batches and a technical evaluation of the process to further understand the factors that may contribute to variability in dissolution of your product. After completing this investigation, you commit to revalidating your process.Your response is inadequate. We note your original validated ranges are not supported, and you did not adequately establish the revised processing parameters to ensure effective remediations for the dissolution failures. In addition, you did not provide sufficient information regarding the design of experimental batch studies to determine root cause of your repeated dissolution failures. We acknowledge you conducted extensive retain testing of product on the market and continue to monitor dissolution stability for product on the market.In response to this letter, provide the following:A copy of your potassium chloride ER capsules investigation (including related studies) into the dissolution failures with actions to thoroughly investigate your process for particle size management and complete retrospective review of all process related changes for potential root cause.A copy of your protocol and subsequent report for your DoE study investigating particle size with different(b)(4)content concentrations of(b)(4)solution for your potassium chloride ER capsules. Also, explain whether your DoE studies include other process parameters that could affect(b)(4)efficacy.A list of all process changes for the potassium chloride ER capsule product since product launch. Include an evaluation of all changes, including whether each change on their own or a combination of changes could have a potential effect on dissolution.A copy of your report from protocol VP/MS/PD/OOS/I111/2024/0040/0024 for assessing the verification batches for(b)(4)capsules.A copy of your study protocol and subsequent report from CAPA (CP/I111/2025/0051) to identify the root cause for the(b)(4)capsule dissolution failures using experimental batches.A copy of your protocol and subsequent report for completing a technical evaluation of dissolution variability from the(b)(4)capsules manufacturing process.A complete review of all drug products with(b)(4)or(b)(4)profiles to determine if additional drug products have adverse process performance or quality signals, including but not limited to, failures related to dissolution or bioavailability.A comprehensive, independent assessment of your overall system for investigating deviations, discrepancies, complaints, OOS results, and failures. Provide a detailed action plan to remediate this system. Your action plan should include, but not be limited to, significant improvements in investigation competencies, scope determination, root cause evaluation, CAPA effectiveness, quality assurance oversight, and written procedures. Address how your firm will ensure all phases of investigations are appropriately conducted.An independent assessment and remediation plan for your CAPA program. Provide a report that evaluates whether the program includes effective root cause analysis, ensures CAPA effectiveness, analyzes investigations trends, improves the CAPA program when needed, implements final quality assurance decisions, and is fully supported by executive management.2. Your firm failed to follow an adequate written testing program designed to assess the stability characteristics of drug products (21 CFR 211.166(a)).You failed to follow your written stability procedure for your finished drug products. For example, you did not complete timely stability testing for approximately(b)(4)stability samples for U.S. commercial drug products within the stipulated timeline ((b)(4)after sample pull). Stability testing was overdue by 3 months or longer for a large proportion of your samples.In your response, you provide details for the backlog of pending stability sample testing, root causes for the delays in stability testing, and state all delayed stability sample testing for U.S. commercial products was completed by December 2024, prior to the inspection. You also implemented quality and executive management oversight for reviewing progress of stability testing, metrics, and upcoming stability testing for resource availability. You developed plans to increase quality control (QC) resources to reduce delayed stability sample testing by increasing QC laboratory capacity, purchasing and qualifying additional equipment, and hiring additional personnel. You plan to perform a stability load assessment for stability samples pulled from March 2025 to December 2025 to evaluate the adequacy of resources in your QC laboratory.Your response is inadequate. You do not include the test results from the delayed stability analyses or a copy of the investigation report with your written response to demonstrate whether backlogged stability testing was completed and adequately investigated for root cause. Also, you do not provide adequate information on your stability load assessment, with pre-defined criteria, to evaluate adequacy of resources for your stability testing program.Additionally, your impact assessment for the delayed stability analyses does not adequately address the risk to patient safety. Your firm’s failure to perform stability dissolution testing for potassium chloride ER capsules and(b)(4)capsules within the specified testing period led to delays in detecting product quality failures, issuing field alert reports1and conducting recalls in a timely manner. For example, in multiple instances, potassium chloride ER capsules dissolution failures were not observed for approximately 100 days after stability samples were pulled.Without an appropriate ongoing stability program, you lack adequate scientific evidence to support whether your drug products meet established specifications and retain their quality attributes through their labeled expiry.In response to this letter, provide:A copy of the completed stability data from the backlogged stability testing. Include a plan of action for any OOS results found from the stability analyses.Your stability load assessment protocol relating to stability samples pulled from March 2025 to December 2025, and the report and CAPA assuring future resource adequacy.A comprehensive, independent assessment and CAPA plan to ensure the adequacy of your stability program. Your remediated program should include, but not be limited to:o Stability indicating methods.o Stability studies for each drug product in its marketed container-closure system before distribution is permitted.o An ongoing program in which representative batches of each product are added each year to the program to determine if the shelf-life claim remains valid.o Detailed definition of the specific attributes to be tested at each station (timepoint).All procedures that describe these and other elements of your remediated stability program.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)).Your firm failed to perform method validation (or verification, as appropriate) of test methods to ensure they were suitable for their intended use. Your senior leadership confirmed multiple test methods used for incoming API and drug product testing of quality attributes, such as(b)(4)content, identification, and specific rotation, have not been validated, verified, or appropriately transferred.In your response, you provide a retrospective gap assessment evaluating the adequacy of your method validation/verification studies for API and drug product test methods for the U.S. market. You also acknowledge certain methods had not been validated or verified, and that you have already completed some of the pending studies. The response includes planned completion dates for remaining validation/verification studies (May 31, 2025 for API methods; April 30, 2025 for finished drug products). Additionally, you commit to perform an impact assessment of the drug products distributed to the U.S. market after completion of relevant method validation/verification studies. We acknowledge you completed an interim impact assessment for all drug products in the U.S. market.Your response is inadequate. Your gap assessment does not adequately address the lack of reference to method validation or verification studies for all appropriate methods, such as your in-house(b)(4)testing and in-house elemental impurities testing for(b)(4)tablets USP(b)(4)mg and(b)(4)mg. Also, your interim impact assessment does not scientifically justify the reliability of your test results in the absence of appropriate method validation/verification studies. System suitability controls and calibration controls for test methods are not an adequate substitute for method validation/verification studies.Method validation and verification studies are necessary to support reliable determination of identity, strength, quality, purity, and potency of drugs. Without evaluating the validity of methods, you lack the basic assurance that your laboratory data accurately reflects drug product quality.Refer to FDA’s guidance documentsQ2(R2) Validation of Analytical Procedures and Analytical Procedures and Methods Validation for Drugs and Biologicsfor general principles and approaches for method validation at https://www.fda.gov/media/161201/download and https://www.fda.gov/media/87801/download, respectively.In response to this letter, provide:A detailed, independent assessment of all test methods to evaluate if they include sufficiently specific instructions to ensure repeatability, are supported by adequate validation (or verification, for United States Pharmacopeia (USP) compendial methods) studies and are appropriate for their intended use. The assessment should also determine whether test methods used in the stability program are stability-indicating. The scope of the assessment should encompass any tests conducted by your firm or its contract laboratories. Based on this review, provide a detailed protocol to remediate and evaluate the effectiveness of your quality system in ensuring test methods are validated (or verified, where appropriate) and suitable for their intended use.(b)(4) ProductionDuring the inspection, we observed you manufacturing drug products containing(b)(4), using equipment and air handling units shared with other drug products. Although complete and comprehensive separation of facilities for manufacturing(b)(4)is not required to prevent cross-contamination, it is important to establish and implement robust cross-contamination prevention strategies (e.g., dedicated production suites).2We acknowledge your decision to discontinue the manufacture of(b)(4)drug products for all markets. If you decide to resume manufacturing of your(b)(4)containing drug products, notify FDA and provide your detailed cross-contamination prevention plan for(b)(4).Repeat Violations at Multiple SitesFDA cited similar CGMP violations at other facilities in your company’s network.Glenmark Pharmaceuticals Limited (Himachal Pradesh, India), FEI 3005757050, was issued a warning letter dated October 3, 2019, for violation of, among other items, 21 CFR 211.192 for failing to adequately investigate multiple OOS test results for critical product attributes, such as failed(b)(4)in your(b)(4)cream USP bulk batch. This site was placed on import alert 66-40 on October 25, 2022.Glenmark Pharmaceuticals Limited (Goa, India), FEI 3004672766, was issued a warning letter dated November 22, 2022, for violation of, among other items, 21 CFR 211.192 for inadequate investigation of OOS results from content uniformity testing of your desmopressin acetate tablets.Glenmark Pharmaceuticals Inc., (North Carolina, U.S.A.), FEI 3011585599, was issued a warning letter dated June 20, 2023, for various CGMP violations of the FD&C Act.These repeated failures at multiple sites demonstrate that management oversight and control over the manufacture of drugs is inadequate.Your executive management remains responsible for fully resolving all deficiencies and ensuring ongoing CGMP compliance. You should immediately and comprehensively assess your company’s global manufacturing operations to ensure that systems, processes, and the products manufactured conform to FDA requirements.Drug Production Ceased and SuspendedWe acknowledge your commitment to cease production of potassium chloride ER capsules and suspend production of(b)(4)capsules at this facility for the U.S. market. In response to this letter, clarify whether you intend to resume manufacturing potassium chloride ER capsules and/or(b)(4)capsules for the U.S. market at this facility in the future.If you plan to resume any manufacturing operations regulated under the FD&C Act, notify this office before resuming your drug manufacturing operations. You are responsible for resolving all deficiencies and systemic flaws to ensure your firm is capable of ongoing CGMP compliance. In your notification to the Agency, provide a summary of your remediations to demonstrate that you have appropriately completed all CAPAs.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 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.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.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.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 refusing admission of articles manufactured at Glenmark Pharmaceuticals Limited, located at Phase – II, Sector III, Plot No 2, Pharma Zone, SEZ, Pithampur, Madhya Pradesh, 454774 India, 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.3Specify 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 3008565058 and ATTN: Sai Dharmaraj.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and Research__________________________1Refer to FDA’s guidance document Field Alert Report Submission for guidance on reporting relevant information for a FAR https://www.fda.gov/media/114549/download.2Refer to Appendix B (https://www.fda.gov/media/159358/download)3Under 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.

Delivery Method:VIA UPSReference #:320-25-91Product:DrugsRecipient:Mr. Emmanuel R. DidierPresident and CEOMedical Chemical Corporation19250 Van Ness AvenueTorrance,CA90501-1102United StatesIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter320-25-91July 9, 2025Dear Mr. Didier:The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Medical Chemical Corporation, FEI 2013736, at 19430 Van Ness Avenue, Torrance, from February 12 to 18, 2025.This warning letter 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).In addition, “MED CHEM Tincture Green Soap” drug product is an unapproved new drug introduced or delivered for introduction into interstate commerce in violation of section 505(a) of the FD&C Act, 21 U.S.C. 355(a), and is misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee). Introduction or delivery for introduction of such product into interstate commerce is prohibited under sections 301(d) and (a) of the FD&C Act, 21 U.S.C. 331(d) and (a). These violations are described in more detail below.Furthermore, we reviewed your firm’s drug listing submissions in FDA’s electronic Drug Registration and Listing System (eDRLS) and found that your drug products, Tincture Green, NDC 12745-041, and Isopropyl Alcohol, NDC 12745-105, are not properly listed as required by section 510(j) of the FD&C Act.Your firm has not fulfilled its listing obligations under 510(j) of the FD&C Act and 21 CFR 207, which is prohibited under section 301(p) of the FD&C Act, 21 U.S.C. 331(p), and will render a drug misbranded under section 502(o) of the FD&C Act, 21 U.S.C. 352(o). The introduction or delivery for introduction of a misbranded drug into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a). These violations are described in more detail below.CGMP ViolationsWe reviewed your February 28, 2025 response to our Form FDA 483 in detail. Your response is inadequate because you failed to provide supportive documentation for evaluation or adequate evidence of corrective actions taken to bring your operations into compliance with CGMP.During our inspection, our investigator observed specific violations including, but not limited to, the following.1. Your firm failed to conduct at least one test to verify the identity of each component of a drug product. Your firm also failed to validate and establish the reliability of your component supplier’s test analyses at appropriate intervals (21 CFR 211.84(d)(1) and 211.84(d)(2)).Your firm manufactures over-the-counter (OTC) topical drug products, including hand sanitizers, Tincture Green Soap USP, and Isopropyl Alcohol 70% v/v. You failed to adequately perform identity testing on each shipment of each lot of incoming components (e.g., ethanol, glycerin) used in the manufacture of your OTC topical drug products. In addition, you relied on your suppliers’ certificate of analysis (COA) without establishing the reliability of your component suppliers’ test analyses at appropriate intervals.Products Containing Ethyl Alcohol and Isopropyl AlcoholYou failed to adequately test your incoming component ethyl alcohol (ethanol), used as an active pharmaceutical ingredient (API), for methanol. The use of ethanol contaminated with methanol has resulted in various lethal poisoning incidents in humans worldwide. See FDA’s guidance document Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol to help you meet the CGMP requirements when manufacturing drugs containing ethanol at https://www.fda.gov/media/173005/download.Furthermore, you failed to demonstrate that the component alcohol (“C40B(b)(4)PROOF SDA 40B ETHYL ALCOHOL BULK”), used to manufacture your drug product Tincture Green Soap USP, meets United States Pharmacopoeia (USP) monograph specifications. For example, we reviewed your raw material specification for your component alcohol and note that the specifications failed to demonstrate performance of the USP monograph identification parts A, B, and C.Products Containing Ingredients at Risk for Diethylene Glycol or Ethylene Glycol (DEG or EG) ContaminationYou also failed to adequately test your incoming components at high risk of diethylene glycol (DEG) or ethylene glycol (EG) contamination for identity before using them to manufacture your drug products. This includes, but is not limited to, testing of glycerin to determine its appropriate identity, prior to use in manufacturing your OTC topical drug products.Identity testing for glycerin and certain other high-risk drug components includes a limit test in the USP to ensure the component meets the relevant safety limits for DEG or EG levels. Because you did not perform identity testing on each shipment of each lot using the USP identification test that detects these hazardous impurities, you failed to assure the acceptability of these components 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.In your response, you state that you perform identity testing, use raw materials certified by trusted suppliers, and have added or will add certain assays to your specifications. Your response is inadequate because you do not provide adequate details to demonstrate identity testing meets all compendial requirements. Furthermore, your response does not address testing your high-risk drug components for DEG or EG contamination, or test ethanol for the presence of methanol contamination. Also, you do not address the potential impact on drug products in the U.S. market within expiry.Without adequate testing, you do not have scientific evidence that the components conform to appropriate specifications before use in the manufacture of your drug products. You are responsible for sampling, testing, and examining drug components before use in production to ensure acceptable quality parameters are met.In response to this letter, provide:A comprehensive, independent review of your material system to determine whether all suppliers of components, containers, and closures, are each qualified and the materials are assigned appropriate expiration or retest dates. The review should also determine whether incoming material controls are adequate to prevent use of unsuitable components, containers, and closures.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 re-validation. In addition, include a commitment to always conduct at least one specific identity test for each incoming component lot. In the case of alcohol, isopropyl alcohol, glycerin, and certain additional high-risk components we note that this includes the performance of parts A, B, and C of the USP monograph.A summary of results obtained from testing all components to evaluate the reliability of the COA from each component manufacturer. Include your standard operating procedure (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.A commitment to provide methanol test results, no later than 30 calendar days from the date of this letter, from testing retains for all lots of components within expiry of manufactured drug products. Alternatively, if a retain of a component lot is unavailable, perform retain sample testing of all implicated finished drug product batches for the presence of methanol.A commitment to provide DEG and EG test results, no later than 30 calendar days from the date of this letter, from testing retains for all lots of high-risk drug components used in the manufacture of drug products. Alternatively, if a retain of a component lot is unavailable, perform retain sample testing of all implicated finished drug product batches for the presence of DEG and EG.A full risk assessment for drug products that are within expiry which contain any ingredient at risk for DEG or EG contamination (including, but not limited to, glycerin). Take prompt and appropriate actions to determine the safety of all lots of the component(s) and any related drug product that could contain DEG or EG, including customer notifications and product recalls for any contaminated lots. Identify additional appropriate corrective actions and preventive actions (CAPA) that secure supply chains in the future, including, but not limited to, ensuring that all incoming raw material lots are from fully qualified manufacturers and free from unsafe impurities. Detail these actions in your response to this letter.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)).You used “(b)(4)water” as a component to manufacture your OTC topical drug products. However, you have not established that the water system is adequately designed, maintained, and monitored to ensure that it consistently produces water suitable for its intended use. You lacked water system validation and failed to conduct total organic carbon (TOC) testing to ensure that your component water met(b)(4)Water United States Pharmacopeia (USP) monograph specifications.Additionally, you obtained excessive microbial growth from the point of use, “(b)(4)(No hose)” location, following(b)(4)water system maintenance sanitization cycles. The inadequate control of your water system poses a potential risk for objectionable microbiological contamination into your drug products.In your response, you state that you will “revalidate” your(b)(4)water system and include TOC testing in your water specification. Your response is inadequate because you do not provide your initial water system validation, nor do you provide adequate details regarding your plan for performing water system validation, maintenance, and testing of the water system. Furthermore, you do not provide a timeline for the validation of your methods, nor do you consider retrospective testing of retained finished drug products that used water.(b)(4)water for pharmaceutical use must be suitable for its intended use and routinely tested to ensure ongoing conformance with appropriate chemical and microbiological attributes. Routine monitoring of microbial counts and identity of contamination in the system is integral to ensuring oversight of ongoing state of control and suitability of water for use in manufacturing operations.Furthermore, test methods must be validated to show they are suitable for their intended use, and equivalent or better than applicable USP compendial methods. The reproducibility of your test methods is essential to determine if your drug products meet established specifications for microbial attributes. The ability of microbial testing methods to detect objectionable microorganisms in the presence of each drug product must be established.In response to this letter, provide:A(b)(4)water system validation report. Also include the summary of any improvements made to system design and to the program for ongoing control and maintenance.A detailed risk assessment addressing the potential effects of the observed water system failures on the quality of all drug product lots currently in U.S. distribution or within expiry. Specify actions that you will take in response to the risk assessment, such as customer notifications and product recalls.The current action/alert limits for total counts and objectionable organisms used for your(b)(4)water system. Ensure that the total count limits for your(b)(4)water are appropriately stringent in view of the intended use of each of the products produced by your firm. Total microbial count limits for(b)(4)water systems are generally tighter than your proposed action limits for the topical liquid dosage forms produced by your firm.A procedure governing your program for ongoing control, maintenance, and monitoring that ensures the system consistently produces water that meets(b)(4)Water, USP monograph specifications and appropriate microbial limits.Validation of your microbiological test methods, including growth promotion testing, demonstrating they are equivalent to, or better than USP compendial methods, and suitable for their intended use.3. Your firm’s quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP, and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22).Your quality unit (QU) failed to perform adequate oversight for the manufacture and testing of your OTC topical drug products. For example, your QU failed to ensure the following:Establishment and review of adequate batch production and control records for each batch of drug product which include complete information regarding each significant step in the manufacture, processing, packing, or holding of the batch (21 CFR 211.188(b)).Establishment and review of adequate laboratory records which include all data obtained during testing (21 CFR 211.194(a)).In your response, you state that you have added the mixing time to the batch record, and you maintain a temperature log of your incubator. Your response is inadequate because you do not provide sufficient details to demonstrate your QU will ensure the establishment and review of manufacturing records.Complete and accurate batch production and control records are necessary to ensure that manufacturing processes are consistently followed and reproducible. Additionally, complete manufacturing records are necessary to reliably conduct batch record review, adequately investigate deviations and batch failures, and to ensure a continued state of validation processes.An adequate QU overseeing all CGMP operations is necessary to ensure consistent drug quality. See FDA’s guidance document Quality Systems Approach to Pharmaceutical CGMP Regulations for 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:A complete assessment of documentation systems used throughout your manufacturing and laboratory operations to determine where documentation practices are insufficient. Include a detailed CAPA plan that comprehensively remediates your firm’s documentation practices to ensure you retain attributable, legible, complete, original, accurate, contemporaneous records throughout your operation.A list of chemical and microbial test methods and specifications used to analyze each of your drug product before making a disposition decision, and the associated written procedures.Unapproved New Drug and Misbranded Drug Violations“MED CHEM Tincture Green Soap” is a “drug” as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or under section 201(g)(1)(C) of the FD&C Act, 21 U.S.C. 321(g)(1)(C), because it is intended to affect the structure or any function of the body.Examples of claims observed on the “MED CHEM Tincture Green Soap” product labeling that provide evidence of the intended uses (as defined in 21 CFR 201.128) of the product as a drug include, but may not be limited to, the following: “Drug Facts Active Ingredients Ethyl Alcohol, 30% Purpose Antiseptic Uses Intended for . . . mild antisepsis of skin . . . Directions Mix with water. Lather and rinse” [from the product label]Based on the above labeling claims, “MED CHEM Tincture Green Soap” is intended for use as a topical antiseptic drug product. This topical antiseptic product is a new drug within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because it is not generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended, or suggested in its labeling. New drugs may not be 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), unless they are lawfully marketed under section 505G of the FD&C Act (which is not the case for this product, as further described below) or other exceptions not applicable here. No FDA-approved application pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, is in effect for this drug product, nor are we aware of any adequate and well-controlled clinical studies in the published literature that support a determination that your “MED CHEM Tincture Green Soap” drug product is GRASE for use under the conditions suggested, recommended, or prescribed in its labeling. Accordingly, this product is an unapproved new drug marketed in violation of sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C 355(a) and 331(d).Over-the-Counter (OTC) topical and oral antiseptic drug products have been the subject of rulemakings under the Agency’s OTC Drug Review. In particular, consumer topical antiseptics were addressed in a tentative final monograph (TFM) entitled “Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products,” Proposed Rule, 59 FR 31402 (June 17, 1994) (1994 TFM), as further amended by “Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use”, Proposed Rule, 78 FR 76444 (December 17, 2013) (Consumer Antiseptic Washes Proposed Rule). Over the course of these rulemakings, three active ingredients (benzalkonium chloride, benzethonium chloride, and chloroxylenol) were classified as Category III for use in consumer antiseptic wash products, meaning that additional safety and effectiveness data are needed to support a determination that a drug product containing one of these active ingredients would be GRASE for use as a consumer antiseptic wash.Section 505G of the FD&C Act governs nonprescription drugs marketed without an approved application. Under section 505G(a)(3) of the FD&C Act, drugs that were classified as Category III for safety or effectiveness in a TFM that is the most recently applicable proposal or determination for such drug issued under 21 CFR Part 330—and that were not classified as Category II for safety or effectiveness – are not required to have an approved application under section 505 in order to be marketed, as long as they are in conformity with the relevant conditions of use outlined in the applicable TFM, including the active ingredient, and comply with all other applicable requirements.However, “MED CHEM Tincture Green Soap” does not conform to the 1994 TFM, as further amended by the Consumer Antiseptic Washes Proposed Rule, nor any other TFM, proposed rule, or final rule, and does not meet the conditions under section 505G(a)(3) of the FD&C Act for marketing without an approved application under section 505. The “MED CHEM Tincture Green Soap” product labeling states that its active ingredient is “Ethyl Alcohol, 30%” and provides the following directions for use: “Mix with water. Lather and rinse.” Your “MED CHEM Tincture Green Soap” product does not conform to the 1994 TFM as further amended or any other TFM or proposed or final rule. As noted above, ethyl alcohol is not one of the three active ingredients classified as Category III for use in consumer antiseptic wash products.1Accordingly, your product does not meet the conditions under section 505G(a)(3) of the FD&C Act for marketing without an approved application under section 505.The introduction or delivery for introduction of this unapproved new drug product into interstate commerce violates sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d).Additionally, “MED CHEM Tincture Green Soap” is misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee), because this product is a nonprescription drug subject to section 505G of the FD&C Act, 21 U.S.C. 355h, but does not comply with the requirements for marketing under that section and is not the subject of an application approved under section 505 of the FD&C Act, 21 U.S.C. 355.The introduction or delivery for introduction of a misbranded drug into interstate commerce violations section 301(a) of the FD&C Act, 21 U.S.C. 331(a).Drug Listing ViolationsSection 510(j) of the FD&C Act, 21 U.S.C. 360(j), and 21 CFR Part 207 outline the requirements for establishment registration and listing of drug products. Under 21 CFR 207.57(b), registrants are required to update drug listing information twice each year, in June and December. Under 21 CFR 207.57(b)(2) registrants may satisfy the listing update requirement with respect to unchanged listing information by making a single “no changes” certification during the October 1st through December 31st annual registration period. If the drug listing data is not updated or certified, the outdated listing data will get inactivated at the next scheduled FDA inactivation period.2Your products, Tincture Green, NDC 12745-041, and Isopropyl Alcohol, NDC 12745-105, were not certified as required, thus they were inactivated by FDA in January 2024.Therefore, your products Tincture Green and Isopropyl Alcohol are not properly listed under section 510(j) of the FD&C Act, rendering these drugs to be misbranded under section 502(o) of the FD&C Act, 21 U.S.C. 352(o). The introduction or delivery for introduction of a misbranded drug into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a). In addition, failure to provide listing information in accordance with 510(j) of the FD&C Act is prohibited under section 301(p) of the FD&C Act, 21 U.S.C. 331(p).Complete, accurate, and up-to-date establishment registration and drug listing information is essential to promote and protect patient safety. FDA relies on establishment registration and drug listing information for several key programs, including drug establishment inspections, supply chain security, and post-market surveillance. Drug registration and listing information is also widely used outside FDA for purposes such as electronic prescribing, electronic health records, insurance reimbursement, and patient education.We note that several of your firm’s drug listings are inactivated/uncertified. Firms must discontinue listed products when manufacturing and commercial distribution cease by adding an end marketing date which corresponds to the expiration date of the last lot in commercial distribution. It is your responsibility to ensure that all products manufactured at your establishment comply with all establishment registration and drug listing requirements under section 510 of the FD&C Act, 21 U.S.C. 360, 21 CFR Part 207, and all other applicable FDA regulations. Registration and listing information and instructions on how to properly register an establishment or submit drug listings can be found atElectronic Drug Registration and Listing Instructions.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.Correct any violations promptly. Failure to promptly and adequately address this matter may result in regulatory or legal action without further notice including, without limitation, seizure and injunction. Unresolved violations may also prevent other Federal agencies from awarding contracts.Failure to address violations may also cause FDA to withhold issuance of Export Certificates. 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 address any violations.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 2013736 and ATTN: Sena G. Dissmeyer.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and Research/S/Tina SmithCaptain, U.S. Public Health ServiceDirectorOffice of Unapproved Drugs & Labeling ComplianceOffice of ComplianceCenter for Drug Evaluation and Research_________________________1We note that “tincture of green soap” was not evaluated as part of the consumer antiseptic wash rulemaking and was not one of the three active ingredients classified as Category III for use in consumer antiseptic wash products. On June 19, 2008, FDA issued a proposed rule that would determine that there were inadequate data to establish general recognition of safety and effectiveness for tincture of green soap for use as the active ingredient in a nonantimicrobial skin wound cleanser product. “Status of Certain Additional Over-the-Counter Drug Category II Active Ingredients,” Proposed Rule, 73 FR 34895, 34901 (June 19, 2008).2See 84 FR 40417 (https://www.regulations.gov/document/FDA-2019-N-2374-0001).

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