行政相对人名称广州×××，万××行政相对人类别法人及非法人组织，自然人行政相对人代码_1(统一社会信用代码)×××法定代表人×××法定代表人证件类型身份证法定代表人证件号码×××行政处罚决定书文号粤药监妆罚〔2025〕2004号违法行为类型生产未经注册的特殊化妆品违法事实当事人于2024年1月8日生产的“×××染发膏葡萄酒红色”（批号：202401WTL，限用日期：2027/1/7，规格：80ml+90ml）被检出产品标签及注册资料载明的技术要求未标示的染发剂：对氨基苯酚、甲苯-2,5-二胺硫酸盐、1-萘酚。当事人生产了该批次化妆品200盒。当事人于2024年1月23日生产的“×××染发膏(自然黑）”（批号：202401，限用日期：2027/1/22，规格：（120ml×2）/盒）被检出产品标签及注册资料载明的技术要求未标示的染发剂：对氨基苯酚、间氨基苯酚、4-氨基-2-羟基甲苯。当事人生产了该批次产品200盒。上述2批次产品为未经注册的特殊化妆品。涉案2批次产品的货值金额是1000元，违法所得是1000元。2023年6月14日，当事人曾因生产未经注册的特殊化妆品、未执行原料以及直接接触化妆品的包装材料进货查验记录制度的行为以及未执行化妆品生产管理和生产记录制度、未执行化妆品成品留样管理和留样记录制度的行为被属地市场监管部门依法行政处罚。当事人的生产许可证已过有效期并被注销。 处罚依据《化妆品监督管理条例》第五十九条第二项处罚类别责令停产停业;其他。处罚内容除属地市场监管部门已对当事人作出罚款等行政处罚外，对当事人还作出如下行政处罚：1.责令停止化妆品经营6个月；2.10年内不予办理其提出的化妆品备案或者受理其提出的化妆品行政许可申请。对万××作出终身禁止其从事化妆品生产经营活动的行政处罚。罚款金额（万元）0没收违法所得、没收非法财物的金额（万元）0处罚决定日期2025年5月8日处罚有效期10年处罚机关广东省药品监督管理局处罚机关统一社会信用代码11440000MB2D034421数据来源单位广东省药品监督管理局数据来源单位统一社会信用代码11440000MB2D034421

行政相对人名称×××有限公司行政相对人类别法人及非法人组织行政相对人代码_1(统一社会信用代码)×××法定代表人×××法定代表人证件类型身份证法定代表人证件号码×××行政处罚决定书文号粤药监妆罚〔2025〕2009号违法行为类型未按照化妆品生产质量管理规范的要求组织生产化妆品违法事实2023年11月27日至11月29日，国家药品监督管理局组织对当事人进行了飞行检查，发现当事人的化妆品生产质量管理体系存在17个项目不符合规定，其中关键项目有1项，重点项目有15项，一般项目有1项。当事人的生产质量管理体系存在严重缺陷。当事人未按照化妆品质量管理规范要求组织生产的化妆品涉及43批次牙膏共计48297支，均已销售完毕，召回数量为0；销售金额共计人民币9940.95元，涉案的43批次牙膏货值金额为人民币9940.95元，违法所得为9940.95元。当事人在2024年2月18日至2024年3月6日擅自恢复生产期间，生产了以下3个类型的产品：1.×××益生菌美白祛渍牙膏（SP-4）1231箱，规格为（120g×72支）/箱，合计生产了88632支；2.×××益生菌美白祛渍牙膏（SIP-4）280箱，规格为（120g×72支）/箱，合计生产了20160支；3.×××防蛀牙膏131箱，规格为（100g×72支）/箱，合计生产了9432支牙膏。当事人在此期间生产的1642箱、共计118224支牙膏上均标注虚假的生产日期“20230726”，货值金额为人民币9457.92元，未发现有销售。此外，当事人还生产了标注虚假生产日期的化妆品。处罚依据《化妆品监督管理条例》第六十条第三项处罚类别吊销许可证证件。处罚内容除属地市场监管部门已对当事人作出的没收违法所得、罚款、责令停产停业等行政处罚外，对当事人还作出如下行政处罚：吊销化妆品生产许可证。罚款金额（万元）0没收违法所得、没收非法财物的金额（万元）0暂扣或吊销证照名称及编号化妆品生产许可证（编号：粤妆20220267）处罚决定日期2025年5月8日处罚有效期3年公示截止期2028年5月8日处罚机关广东省药品监督管理局处罚机关统一社会信用代码11440000MB2D034421数据来源单位广东省药品监督管理局数据来源单位统一社会信用代码11440000MB2D034421

行政相对人名称成都市明德药业有限公司行政相对人类别法人组织行政相对人统一社会信用代码91510181MA69HKUH39法定代表人成东行政处罚决定书文号川药监罚决〔2025〕1002号违法行为类型生产销售劣药中药饮片淫羊藿违法事实2023年5月28日至2024年10月9日，生产销售了“总黄酮”、“总黄酮醇苷”含量不符合规定的中药饮片淫羊藿（批号：24020101，包装规格：0.5㎏/袋、10g/袋）共141㎏，货值金额25504.94元，违法所得16077.35元。处罚依据《中华人民共和国药品管理法》第一百一十七条第一款。处罚类别没收非法财物、没收违法所得、罚款处罚内容1.没收违法生产的“淫羊藿”（批号：24020101）46.42㎏，没收违法所得16077.35元；2.罚款100000元。罚款金额（元）100000元没收违法所得、没收非法财物的金额（元）16077.35元处罚决定日期2025年4月30日处罚机关四川省药品监督管理局处罚机关统一社会信用代码11510000MB1808933T

为加强医疗器械质量监督管理，保障医疗器械产品安全有效，按照《医疗器械监督管理条例》及《河北省医疗器械监督抽验管理办法》有关规定，省药品监督管理局组织对2024年全省生产、经营和使用等环节医疗器械进行了质量监督抽检。发现10批次产品（详见附件）不符合标准规定，并已依法分别予以查处，现予以公开。特此公告。附件：10批次不符合规定医疗器械产品信息.pdf河北省药品监督管理局2025年5月14日

行政相对人名称四川微迪数字技术有限公司行政相对人类别法人组织行政相对人统一社会信用代码91510100716092123A法定代表人钟茂行政处罚决定书文号川药监罚决〔2024〕1032号违法行为类型生产销售未取得医疗器械注册证的第二类医疗器械违法事实2021年4月4日至2024年11月28日，当事人将已注册的第二类医疗器械“耳鸣声综合诊断治疗仪”的部件“掩蔽器存储介质”单独包装为新的第二类医疗器械产品，命名为“耳鸣声治疗器”，冒用“耳鸣声综合诊断治疗仪”的注册编号（川械注准20152070025），共生产554台，货值金额439887.08元，违法所得为281216元。处罚依据《医疗器械监督管理条例》第八十一条第一款第一项处罚类别没收非法财物、没收违法所得、罚款处罚内容1. 没收违法生产产品“耳鸣声治疗器”220台； 2.没收违法所得281216元；3.罚款219943.54元。罚款金额（元）219943.54没收违法所得、没收非法财物的金额（元）281216处罚决定日期2025年4月30日处罚机关四川省药品监督管理局处罚机关统一社会信用代码11510000MB1808933T

安徽省药品生产监督检查信息通告（2025年4月）序号检查企业名称检查类型检查时间检查综合评定结论处理措施备注1新宇药业股份有限公司常规检查2025年1月6日— 8日符合要求2上海赛睿宿州药业有限公司常规检查2025年3月4日－ 5日符合要求3合肥国药诺和药业有限公司其他检查2025年3月24日－ 25日符合要求4蚌埠丰原涂山制药有限公司其他检查2025年3月24日－ 25日符合要求5蚌埠东方气体有限公司其他检查2025年3月25日未发现违法违规行为停产企业巡查6蚌埠火鹤制药股份有限公司其他检查2025年3月25日未发现违法违规行为停产企业巡查7安徽杰玺医药有限公司其他检查2025年3月26日符合要求8安徽丰乐香料有限责任公司其他检查2025年3月27日符合要求9大玮（安徽）药业有限公司其他检查2025年4月1日符合要求10国药集团三益药业（芜湖）有限公司常规检查2025年4月1日－ 3日符合要求11安徽国森药业有限公司其他检查2025年4月2日符合要求12安徽马钢气体科技有限公司常规检查2024年4月2日－ 3日符合要求13合肥今越制药有限公司其他检查2025年4月3日符合要求14芜湖先声中人药业有限公司其他检查2025年4月9日未发现违法违规行为停产企业巡查15安徽国正药业有限公司其他检查2025年4月9日符合要求16桂龙药业（安徽）有限公司常规检查2024年4月15日－ 17日符合要求17安徽华辰制药有限公司常规检查2025年4月15日－ 4月18日符合要求18安徽双鹤药业有限责任公司常规检查2025年4月15日－ 18日符合要求19合肥立方制药股份有限公司其他检查2025年4月22日－ 25日符合要求20上海庆安药业集团宿州制药有限公司常规检查2025年4月23日－ 25日符合要求

序号行政处罚决定书文号案件名称违法企业名称或违法自然人名称违法企业组织机构代码证/ 统一社会信用代码法定代表人/负责人姓名主要违法事实行政处罚内容决定机关名称处罚决定日期公示日期备注1渝药监械处罚〔2025〕2号重庆秀雨药业有限公司生产不符合注册的产品技术要求的高渗海水鼻腔护理液案重庆秀雨药业有限公司91500224MA605GXB9N        章家伟当事人生产的“高渗海水鼻腔护理液（批号：202408061）”，经江西省医疗器械检测中心检验，检验结论为：不合格。当事人的行为违反了《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》第八十六条第一项、《中华人民共和国行政处罚法》第二十八条第二款的规定，责令当事人改正违法行为，并决定给予行政处罚如下：1.没收高渗海水鼻腔护理液（批号：202408061)564瓶；2.没收违法所得827元；3.罚款5000元。重庆市药品监督管理局2025.05.122025.05.14

为加强药品质量监督管理，保障公众用药安全，山西省药品监督管理局按照《2024年山西省药品监督抽检计划》，组织对全省药品生产、经营企业和使用单位进行药品质量抽查检验。现将抽检发现的不符合规定的6批次药品信息予以通告（详见附件）。对不符合规定的药品，我省各级药品监督管理部门已要求相关企业和单位采取暂停销售、使用等风险控制措施，对不符合规定原因开展调查并切实进行整改。对不符合规定的药品，监管部门已依法组织开展对相关企业和单位的查处。特此通告。 附件：2024年药品抽检不符合规定信息汇总表（2025年第1期） 山西省药品监督管理局      2025年5月13日 （主动公开） 附件  2024年药品抽检不符合规定信息汇总表（2025年第1期）序号药品品名标示生产企业名称药品规格批号检品来源检验依据检验结果不符合规定项目检验单位备注1骨碎补酒泉市培丰中药材生态种植加工有限公司中药饮片181101和顺县华芝大药房《中国药典》2015年版一部不符合规定性状山西省检验检测中心2白芍安徽友方中药饮片有限公司中药饮片230601晋中榆次仁信医院《中国药典》2020年版一部不符合规定检查（二氧化硫残留量）、含量测定晋中市综合检验检测中心3麸炒山药国药健康亳州药业有限公司中药饮片230701晋中榆次仁信医院《中国药典》2020年版一部不符合规定性状、检查（二氧化硫残留量）晋中市综合检验检测中心4金银花安国市安兴中药饮片有限公司中药饮片C226240301平定民众复康医院《中国药典》2020年版一部、四部不符合规定检查（33种禁用农药—氟虫腈）阳泉市综合检验检测中心5金银花河北康典药业有限公司中药饮片20230601阳泉市郊区医疗集团荫营分院《中国药典》2020年版一部、四部不符合规定检查（33种禁用农药—克百威）阳泉市综合检验检测中心6龙眼肉山西欣晋元中药科技有限公司中药饮片231201长治市屯留区人民医院《中国药典》2020年版一部不符合规定检查（水分）长治市综合检验检测中心

Delivery Method:Via Electronic Mail - Delivery and Read Receipt RequestedProduct:DrugsRecipient:Viraj GandhiCEOTailstorm Health Inc. dba Medivant Health24416 N. 19th Avenue Suite 200Phoenix,AZ85085-1400United StatesIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERWL # 703497April 8, 2025Dear Mr. Gandhi: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 23, 2019, and most recently on December 18, 2024. From September 24, 2024, to October 10, 2024, an FDA investigator inspected your facility, Tailstorm Health Inc. dba Medivant Health located at 24416 N. 19th Avenue Suite 200, Phoenix, AZ 85085. 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 and an amended Form FDA 483 to your facility on October 10, 2024. FDA acknowledges receipt of your facility’s responses, dated October 31, 2024, December 9, 2024, and January 23, 2025. FDA also acknowledges that on November 6, 2024, your firm initiated a voluntary recall of lots D24005, D24006, D24007, D24008, D24009, and D24012 of Bevacizumab (Avastin) 1.25mg/0.05mL, 0.5 mL Single-Dose Syringe, intended or expected to be sterile, within expiry, 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)]).Furthermore, for a compounded drug product to qualify for the exemptions under section 503B, it must be compounded in an outsourcing facility that is in compliance with the registration and reporting requirements in section 503B(b), including the requirement to submit adverse event reports to FDA “in accordance with the content and format requirements established through guidance or regulation under section 310.305 of title 21, Code of Federal Regulations (or any successor regulations)” (section 503B(a)(1), (b)(5) of the FDCA [21 U.S.C. § 353b(a)(1), (b)(5)]).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 that:1. Your facility’s drug products, such as Semaglutide Injection 1mg/0.2ml and Tirzepatide Injection 2.5mg/0.5ml, did not include the following on the label: “Office Use Only.”2. Your facility did not submit adverse event reports to FDA in accordance with the content and format requirements established through guidance or regulation under section 310.305 of title 21, Code of Federal Regulations (or any successor regulations). Specifically, your facility’s procedures for reporting adverse events are inadequate. For example, your documented procedures for reporting adverse events do not describe an adverse event as “unexpected” when one is not listed in the current labeling for the drug product (21 CFR 310.305(b) and do not provide that adverse events should be reported utilizing FDA’s Safety Reporting Portal (SRP) or Electronic Submission Gateway (ESG) (21 CFR 310.305(e)).3Because 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 failed to perform adequate smoke studies under dynamic conditions to demonstrate unidirectional airflow within the ISO 5 area. Therefore, your products intended to be sterile are produced in an environment that may not provide adequate protection against the risk of contamination.The FDA investigator also noted CGMP violations at your facility, that caused your drug 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 establish an adequate system for monitoring environmental conditions in aseptic processing areas (21 CFR 211.42(c)(10)(iv)).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.4Under 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.5The 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 also acknowledge your recall of lots D24005, D24006, D24007, D24008, D24009, and D24012 of repackaged Bevacizumab (Avastin) 1.25mg/0.05mL, 0.5 mL Single-Dose Syringe, intended or expected to be sterile, within expiry, due to lack of sterility assurance.Regarding your responses related to the insanitary conditions and CGMP violations, some of your proposed corrective actions appear adequate; however, we are unable to fully evaluate some of your corrective actions due to lack of adequate supporting documentation:1. Regarding particulate matter testing of your finished drug products:a. We have reviewed your document titled, “Retrospective Review Investigation of Reported OOS incidents (1B).” Within that document, you state, “Tailstorm has researched the product Avastin, which contains Bevacizumab, a protein that may interfere with liquid-borne particle count testing. The nature of the product can lead to inconsistent results when tested microscopically using Method(b)(4).” You also stated that, “The test method and procedure were found to involve many physical maneuvers” and that, “the preliminary sample preparation steps are not protected under a bio-safety cabinet/LAF (laminar air flow).” Despite these concerns, your firm relied on passing results via method(b)(4)to release lots D24006, D24007, and D24009.b. Your response did not address the approval process for changes occurring at your contract testing facility. FDA is aware that many drug manufacturers use independent contractors such as testing laboratories. FDA regards contractors as extensions of the manufacturer. You are responsible for the quality of your drugs regardless of agreements in place with your contract facility. See FDA’s guidance document Contract Manufacturing Arrangements for Drugs: Quality Agreements at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/contract-manufacturing-arrangements-drugs-quality-agreements-guidance-industry.c. For Bevacizumab lot D24008, your investigation identified elastomer/rubber particles and noted, “source is syringe stopper or syringe cap rubber seal.” However, you did not provide the actions you took to correct and prevent the recurrence of these particles. Your action plans should include, but not be limited to, significant improvements in investigation competencies, scope determination, root cause evaluation, corrective action and preventive action (CAPA) effectiveness, and quality assurance oversight.Some of your corrective actions appear deficient:1. Regarding your updated smoke studies provided in your response:a. The dynamic smoke study in your video titled “Removal of(b)(4)layer from the tub” under file name “Act 21” does not show smoke in the area in which the open tub of what appears to be product syringes is moved during time 00:51 to 00:58. This same area shows air turbulence during your static smoke study video “(b)(4)Removal” under file name “Act(b)(4)” during time(b)(4).b. The smoke study in your video titled “Replacement of Needle (Open door)” under file name “Act 44” does not appear to encompass all areas within the ISO 5(b)(4)including but not limited to the interventions performed by the operator during needle replacement.2. Regarding your personnel monitoring program, we have reviewed your provided evaluation and acknowledge your statement that, “the practice of breaking first air with the head and chest during open(b)(4)doors interventions has been remediated.” We also acknowledge that you have updated your SOP to “add personnel monitoring sample sites of the right shoulder and left shoulder for the machine assembly process.” However, in our review of your updated smoke study titled “Act 15” it appears that your operator’s head and goggles enter the ISO 5 space within the(b)(4).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 state that you have “revised the affected labels to include the necessary statements and enhance the label review and approval process to ensure compliance with all regulatory standards in the future.”You did not address certain issues related to the conditions of section 503B of the FDCA. More specifically, your SOP for adverse event reporting does not adequately address adverse event reporting. For example, your procedures do not adequately define what constitutes an “unexpected” adverse event and your procedures do not provide that adverse events should be reported utilizing the Safety Reporting Portal (SRP) or Electronic Submission Gateway (ESG).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.All correspondence should refer to the Warning Letter Number above (# 703497) and include a subject line that clearly identifies the submission as a Response to Warning Letter. If you have questions regarding the contents of this letter, please contact compoundinginspections@fda.hhs.gov.Sincerely,/S/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.3For more information, see, FDA’s guidance, “Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act,” which can be found at https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM434188.pdf.4The 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.5Your 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 RequestedProduct:DrugsRecipient:OSRX, Inc.1120 Kensington AveMissoula,MT59801-5619United StatesIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERWL # 701889April 23, 2025Dear Ms. Frost: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 28, 2023, and most recently on October 25, 2024. From October 16, 2024, to October 25, 2024, an FDA investigator inspected your facility, OSRX, Inc., located at 1120 Kensington Ave, Missoula, Montana 59801. During the inspection, the investigator collected evidence indicating 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 October 25, 2024, and issued an amended Form FDA 483 on November 4, 2024. FDA acknowledges receipt of your facility’s response, dated November 15, 2024. 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 collected evidence indicating that drug products produced by your facility failed to meet the conditions of section 503B. For example, the investigator collected evidence indicating that:1. Your facility’s drug products, such as Prednisolone Phosphate 1% Moxifloxacin 0.5% 5ml Sterile Ophthalmic Solution and Atropine Sulfate 0.025% 3.5ml Sterile Ophthalmic Solution, did not include the following on the label: a list of active and inactive ingredients, identified by established name and the quantity or proportion of each ingredient.2. Your facility’s drug products, such as such as Prednisolone Phosphate 1% Bromfenac 0.075% 5ml Sterile Ophthalmic Solution and Moxifloxacin 0.5% Bromfenac 0.075% 5ml Sterile Ophthalmic Solution, did not include the following information on the container: (1) information to facilitate adverse event reporting: www.fda.gov/medwatch and 1-800-FDA-1088; and (2) directions for use, including, as appropriate, dosage and administration.Because your compounded drug products have not met all of the conditions of section 503B, they are not eligible for the exemptions in that section from the FDA approval requirements of section 505, the requirement under section 502(f)(1) that labeling bear adequate directions for use, and the Drug Supply Chain Security Act requirements described in section 582 of the FDCA.Specific violations are described below.C. Violations of the FDCAAdulterated Drug ProductsThe FDA investigator noted that drug products intended or expected to be sterile were prepared, packed, or held under insanitary conditions, whereby they may have become contaminated with filth or rendered injurious to health, causing your drug products to be adulterated under section 501(a)(2)(A) of the FDCA. For example, the investigator observed:1. Your firm failed to perform adequate smoke studies under dynamic conditions to demonstrate unidirectional airflow within the ISO 5 classified critical area. Therefore, your products intended to be sterile are produced in an environment that may not provide adequate protection against the risk of contamination. Specifically, you did not include(b)(4)operators working inside the ISO 5(b)(4)Biosafety Cabinet (BSC) simultaneously to perform check weighing, filling, and capping activities, as per your production activities.2. You did not perform adequate product evaluation and take appropriate corrective action after microbial contamination was recovered within the ISO 5 aseptic processing area.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 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)).2. 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).3. Your firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas (21 CFR 211.42(c)(10)(iv)).4. Your firm failed to establish and follow adequate control procedures to monitor the output and to validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product (21 CFR 211.110(a)).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 response to the Form FDA 483. We are unable to fully evaluate some of your corrective actions due to lack of adequate supporting documentation:1. Regarding your firm’s failure to simulate the worst-case scenarios of your production process during Aseptic Simulation Process (APS), your firm did not provide your ASP demonstrating simulated worst-case scenarios to include largest number of container units aseptically filled, longest filling duration, performance of identified interventions and aseptic filling operators who are deemed as “Full Qualification”.2. Regarding your firm’s failure to incubate all integral media fill units, your firm states as part of a corrective action you opened CAPA OEPA-2024-00771.1 and closed it on October 16, 2024, and submitted in your response SOP-CC-0003 titled “Aseptic Process Simulation – Media Fills, Effective Date: Oct 9, 2024”. You stated you would submit a revised SOP-CC-0003, however we received SOP-CC-003 with an effective date of October 9, 2024, which is prior to the FDA inspection. In addition, you failed to provide a revised media fill master batch production record to reflect that all APS media fill units will be incubated and documentations for the reasons why units are rejected.3. Regarding your firm’s failure to establish a gowning qualification program for operators entering the ISO classified areas, your firm provided Document Change Request Number DCR-2024-0114, approved on November 3, 2024, to address a lack of gowning qualification program at your facility for entry to Cleanroom Suite 100, room number(b)(4)(ISO 7) and room number(b)(4)(ISO 7), from the gowning in airlock (room number(b)(4)) ensuring sterile gowning is donned without contamination. However, changes to procedures FRM-CC-004.1, SOPCC-0023, TRAIN-0005, FRM-CC-0007.2, FRM-CC-0005.2, and FRM-CC-0023.1 remain pending with an estimated completion date of first quarter 2025 as stated in your response.4. Regarding your firm’s failure to establish a dynamic smoke study report/video simulating(b)(4)employees inside the ISO 5(b)(4)Biosafety Cabinet (BSC) performing check weights, filling and capping activities, your firm committed to repeat the OSRX smoke study video in December 2024. However, you did not provide the revised dynamic smoke study report/video.5. Regarding your firm’s failure to thoroughly investigate microbial contamination in the ISO 5 BSC during production, your response failed to ensure a thorough investigation is performed for any microbial recovery in the ISO 5 environment. Your investigations did not include environmental trending reports for each personnel performing work inside the ISO 5 classified area when microorganisms were recovered inside the ISO 5BSC from active viable air sampling plates.Any microbial contamination in the ISO 5 area is considered an insanitary condition and is a serious concern. Upon recovery, your firm should immediately assess the impact on drug products produced. This assessment should include a thorough evaluation of how contamination could have entered this critical area, and over what period of time the contamination could have existed, as well as drug products that remain on the market that could be affected.6. Regarding your firm’s failure to investigate labeling inspection failures that exceeded your specification limits, your investigation document QE-2024-0133 into labeling visual inspection failures, due to wrinkled labels on the bottles, did not include documented training records of all visual inspection personnel for reporting production quality events (deviations/investigations).7. Regarding your firm’s failure to perform viable surface sampling in the ISO 5(b)(4)during filling of a drug product, your response included CAPA QEPA-2024-0121.1, approved on October 22, 2024, which states all compounding and environmental monitoring personnel were trained emphasizing the requirements for surface sampling with each compounded lot. However, you did not provide documentation of retraining of all compounding and environmental monitoring personnel with the requirements set forth under SOP-CC-0026 titled “Routine Environmental Monitoring Cleanroom 100, Effective date Jul 15, 2024”.8. Regarding your firm’s failure to provide justification for sampling(b)(4)units from two totes to examine for visual inspection as a form of an Acceptable Quality Limit (AQL), your response states your AQL visual inspection samples are selected from a batch(b)(4)from two totes, with(b)(4)samples selected from one tote, and(b)(4)samples from the other, thus representative of the entire batch. You did not provide a scientific rational for selecting the two totes to be sampled; furthermore, you did not provide the revised master batch records for all your drug products.Some of your corrective actions appear deficient:1. We acknowledge that you stated in your response that you will revise SOP-CC-0026 titled “Routine Environmental Monitoring Cleanroom 100 to address a change in the action limit for the number of Colony Forming Units (CFUs) to(b)(4)CFUs, however, your estimated completion date is(b)(4). Furthermore, you failed to implement an interim corrective action to address the reclassification of the action limit to(b)(4)CFU for the ISO5 classified areas.2. We acknowledge your commitment to retraining operators to conduct fingertip sampling, however, you did not provide a justification why it would be completed first quarter 2025. Furthermore, your SOP states to use(b)(4)fingers instead of five when applying pressure to the agar plate.3. We acknowledge that you provided SOP-INSP-0003 titled “Visual Inspector Qualification, Effective Date May 20, 2024” but did not address how you intend to qualify your visual inspection sample defect library/kits used for operator visual inspection training of topical ophthalmic solutions nor provide an approved procedure as to how you establish and maintain your sample defect library/kits.4. You reference USP Visual Inspection of Injections and you did not commit to performing 100% visual inspection of all drug products including your sterile topical ophthalmic solutions contained in opaque droptainers and sterile injectable intraocular solution contained in glass vials.USP Ophthalmic Products – Quality Tests considers the 100%-unit inspection as the complete nondestructive inspection of the container-closure system and its contents. The 100%-unit inspection is applied to all ophthalmic products: topical, intraocular injections or ophthalmic products used in association with a surgical procedure, and extraocular injections. An evaluation of the package and fill acceptability methodology is discussed in the Visible Particulates in Injections for your reference. Furthermore, the acceptance limits for visible particles should be based your process capability as established during product development. The recommendation is to study and trend the particle burden of the product solution and the container–closure contribution, develop a reasonable life-cycle control strategy, and establish limits based on risk assessment.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. [See 21 CFR 210.1(b), 21 CFR 200.10(b).]Furthermore, regarding issues related to the conditions of section 503B of the FDCA, some of your corrective actions appear adequate. Specifically, you state that “OSRX is in the process of updating its SOP-DST-0002 to include a step for labeling the clear plastic container with a label… that contains the information required under 503B(a)(10)(B).” However, no corrective actions have been provided to the agency to address label issues concerning a list of active and inactive ingredients, identified by established name and the quantity or proportion of each ingredient.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.All correspondence should refer to the Warning Letter Number above (# 701889) and include a subject line that clearly identifies the submission as a Response to Warning Letter. If you have questions regarding the contents of this letter, please contact compoundinginspections@fda.hhs.gov.Sincerely,/S/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).