行政相对人名称哈尔滨市东方哥德堡大药房有限公司行政相对人代码(统一社会信用代码)91230111070020058C法定代表人赵刘香行政处罚决定书文号哈松市监处罚〔2025〕026015号违法行为类型药品违法事实哈尔滨市东方哥德堡大药房有限公司在医疗器械网络交易服务第三方平台“美团网”经营的人类免疫缺陷病毒抗体（HIV1/2）检测试剂（胶体金法）的行为违反《医疗器械网络销售监督管理办法》第十三条第一款（从事医疗器械网络销售的企业，经营范围不得超出其生产经营许可或者备案的范围。医疗器械批发企业从事医疗器械网络销售，应当销售给具有资质的医疗器械经营企业或者使用单位。医疗器械零售企业从事医疗器械网络销售，应当销售给消费者。销售给消费者个人的医疗器械，应当是可以由消费者个人自行使用的，其说明书应当符合医疗器械说明书和标签管理相关规定，标注安全使用的特别说明。）的规定。处罚依据应依据《医疗器械网络销售监督管理办法》第四十四条第一款第一项（有下列情形之一的，由县级以上地方食品药品监督管理部门责令改正，处 1 万元以上 3 万元以下罚款：（一）从事医疗器械网络销售的企业超出经营范围销售的；（二）医疗器械批发企业销售给不具有资质的经营企业、使用单位的。医疗器械零售企业将非消费者自行使用的医疗器械销售给消费者个人的，依照前款第一项规定予以处罚）的规定予以处罚。处罚类别罚款处罚内容罚款人民币1万元罚款金额（万元）1处罚决定日期2025-02-20处罚有效期2099-12-31公示截止期2028-02-20处罚机关哈尔滨市松北区市场监督管理局相关推荐CIO提供以下相关文库下载、合规服务以及线上培训课程学习。

2024年北京市药品监督管理局按照《北京市2024年药品（含药包材）、医疗器械、化妆品质量抽查检验工作实施方案》组织对药品生产、经营、使用环节开展了监督抽检，现将抽检发现不符合规定的4批药品予以公告（详见附件）。相关单位已对不合格产品采取了必要的控制措施。依据有关法律法规对不合格产品进行查处。特此公告。附件：1.不符合规定药品名单2.不符合规定项目的小知识北京市药品监督管理局2025年2月13日附件1不符合规定药品名单药品名称标示药品上市许可持有人标示生产企业批号规格抽样环节检品来源检验依据检验结论不符合规定项目检验机构备注葛根芩连丸广西壮族自治区花红药业集团股份公司广西壮族自治区花红药业集团股份公司20240202每1g相当于饮片6.67g使用单位北京市鼓楼中医医院《中华人民共和国药典》2020年版一部不符合规定[性状]北京市药品检验研究院经标示生产企业所在地药品监管部门核查，未提出异议瓜蒌/北京仟草中药饮片有限公司240222006中药饮片使用单位北京汇海中医医院《中华人民共和国药典》2020年版一部不符合规定[性状]（发霉）北京市房山区食品药品安全监控中心检查生产企业留样未发现霉变薏苡仁/北京仟草中药饮片有限公司240311006中药饮片使用单位北京汇海中医医院《中华人民共和国药典》2020年版一部不符合规定[性状]（发霉）北京市房山区食品药品安全监控中检查生产企业留样未发现霉变蒲公英/北京明辉恒通药业有限公司22021801中药饮片使用单位北京康健丰旺医院管理有限公司源春丽中医诊所《中华人民共和国药典》2020年版一部不符合规定[性状]（有虫蛀）北京市平谷区市场监督管理局检验检测中心检查生产企业留样未发现虫蛀附件2不符合规定项目的小知识性状项下记载外观、臭、味、溶解度以及物理常数等，在一定程度上反映药品的质量特性。中药饮片性状项不符合规定，可能涉及药材种属偏差、炮制工艺有瑕疵、储存不当等情形。相关推荐CIO提供以下相关文库下载、合规服务以及线上培训课程学习。

近日，宁夏药品审评查验和不良反应监测中心（以下简称宁夏中心）以线上线下相结合的方式，组织召开2024年医疗器械重点品种注射泵不良事件监测工作总结会。宁夏药品监督管理局医疗器械监管处、江苏省药品不良反应监测中心、浙江省医疗器械不良事件监测中心、中国人民解放军器械不良反应监测中心、我区各市监测机构、区内外18家监测哨点医院、5家被遴选注册人及专家代表共50余人参加会议。会上，宁夏中心宣布了6家优秀哨点单位名单，通报了2024年宁夏重点监测工作完成情况及问题，5家哨点医院、注册人代表对2024年度重点监测工作开展情况、亮点工作、存在问题进行了交流发言。国家药品评价中心专家通过视频方式给予了技术指导，提出了具有很强针对性、建设性和可操作性的指导意见。宁夏药监局党组成员、副局长郭涛出席会议并讲话，要求各相关单位要认真落实“四个最严”要求，锚定目标，靶向发力，正视问题，总结反思，主动监测，开拓思路，全力完成好宁夏医疗器械不良事件重点监测工作。本次会议的召开，系统总结了2024年宁夏重点监测工作，同时推广各监测单位的好的做法和亮点工作，梳理分析了短板弱项，并明确了今后改进方向，为我区重点监测工作积累了宝贵经验。相关推荐CIO提供以下相关文库下载、合规服务以及线上培训课程学习。

行政相对人名称深圳*****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**CHUN行政处罚决定书文号粤药监药罚〔2025〕3001号违法行为类型在药品注册过程中提供虚假的数据、资料骗取临床试验许可违法事实当事人于2023年12月22日向国家药监局提交了药品“********”境内生产药品注册临床试验许可申请（受理号CXSL*******），随上述申请所提交的申报材料中，《*******单次静脉注射给予荷瘤NOG小鼠的组织分布试验总结报告》及《荧光定量PCR检测*******在NOG荷瘤小鼠体内分布的方法验证总结报告》均系在没有实际实施临床前试验的情况下由当事人伪造。处罚依据《药品管理法》一百二十三条处罚类别罚款处罚内容罚款550000元罚款金额（万元）55处罚决定日期2025年1月27日处罚有效期12个月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相关推荐CIO提供以下相关文库下载、合规服务以及线上培训课程学习。

Delivery Method:VIA Electronic MailReference #:320-25-43Product:DrugsRecipient:Mr. Vick MaharajChief Executive OfficerMarshalls Traditional Healthcare CC560 Main Reef RoadGermistonGauteng1400South AfricaIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter320-25-43February 10, 2025Dear Mr. Maharaj:The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Marshalls Traditional Healthcare CC, FEI 3014740544, at 560 Main Reef Road, Germiston, from September 19 to 23, 2024.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 product is 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 October 11, 2024, response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence.CGMP Violations1. Your firm failed to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release. Your firm also failed to conduct, for each batch of drug product, appropriate laboratory testing, as necessary, required to be free of objectionable microorganisms (21 CFR 211.165(a) and 211.165(b)).Your firm manufactures an over-the-counter (OTC)(b)(4)drug product. Your firm failed to conduct adequate finished product release testing for each batch of your drug product, including but not limited to, testing the identity and strength of the active ingredient,(b)(4)and testing for objectionable microorganisms.In your response, you state that you developed and validated an updated test method, and updated release specifications, for the labeled active ingredient,(b)(4). You also state that you will perform all appropriate USP and testing for your finished drug products. Your response is inadequate as you did not provide sufficient details regarding the specific tests to be performed for each batch of finished drug product. You also did not consider a risk assessment or retrospective review of products that have been released without appropriate testing.Without adequate finished product release testing, you do not have scientific evidence that each batch of drug product conforms to appropriate specifications before release.In your response to this letter, provide:A comprehensive, independent assessment of your laboratory practices, procedures, methods, equipment, documentation, and analyst competencies. Based on this review, provide a detailed plan to remediate and evaluate the effectiveness of your laboratory system.A list of chemical and microbial specifications, including test methods, used to analyze each lot of your drug products before a lot disposition decision.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, and to follow all of your written production and process control procedures (21 CFR 211.100(a) and 211.100(b)).Inadequate Process ValidationYou did not have data to demonstrate that you adequately validate your manufacturing processes used to manufacture your OTC drug products and demonstrate that your processes are reproducible and controlled to consistently yield drugs of uniform character and quality. For example, your validation plan, “VALIDATOIN MASTER PLAN (VMP),” describes requirements for process validation and hold time studies. However, the protocol implementing your validation planed, “PROCESS VALIDATION PROTOCOL,” failed to include operating parameters, such as bulk hold times, or processing limits, such as acceptance criteria for process parameters.In your response, you provided your updated process validation protocol. Your response is inadequate as it did not include hold times and lacked appropriate details such as adequate sampling instructions. The updated protocol also did not include the batch production record associated with the first validation batch.Process validation evaluates the soundness of design and state of control of a process throughout its lifecycle. Each significant stage of a manufacturing process must be designed appropriately and assure the quality of raw material inputs, in-process materials, and finished drugs. Process qualification studies determine whether an initial state of control has been established. Successful process qualification studies are necessary before commercial distribution. Thereafter, ongoing vigilant oversight of process performance and product quality is necessary to ensure you maintain a stable manufacturing operation throughout the product lifecycle.See FDA's guidance for industry, Process Validation: General Principles and Practices for general principles and approaches that FDA considers appropriate elements of process validation athttps://www.fda.gov/media/71021/download.Inadequate Control of(b)(4)SystemYour firm uses(b)(4)as a component to manufacture your OTC drug product. You failed to ensure that your(b)(4)system is suitable for producing(b)(4)used in the formulation of your drug product. For example, you turned your(b)(4)system off when not in use, stopping its circulation, which deviates from its design use as a continuously recirculating system. In addition, you failed to demonstrate that your(b)(4)system is adequately monitored to ensure it consistently produces(b)(4)that meets appropriate chemical and microbial attributes.In your response, you state that your(b)(4)system will continuously(b)(4). Your response is inadequate. You did not address the adequacy of your overall(b)(4)system design to ensure that your(b)(4)meets, at a minimum, the USP(b)(4)monograph and appropriate microbial limits. You also did not provide interim measures and assess the impact of using(b)(4)from an inadequately validated(b)(4)system on the quality of drug products you manufacture.Pharmaceutical(b)(4)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 maintaining a state of control and suitability of(b)(4)for use in manufacturing operations.In your response to this letter, provide:A detailed summary of your validation program for ensuring a state of control throughout the product lifecycle, along with associated procedures. Describe your program for process performance qualification (PPQ), and ongoing monitoring of both intra-batch and inter-batch variation to ensure a continuing state of control.A timeline for performing appropriate PPQ for each of your marketed drug products.Process performance protocol(s), and written procedures for qualification of equipment and facilities.A detailed program for designing, validating, maintaining, controlling and monitoring each of your manufacturing processes that includes vigilant monitoring of intra-batch and inter-batch variation to ensure an ongoing state of control. Also, include your program for qualification of your equipment and facility.A comprehensive remediation plan for the design, control, and maintenance of the(b)(4)system.A(b)(4)system validation report. Also include the summary of any improvements made to system design and to the program for ongoing control and maintenance.Your total microbial count limits to monitor whether this system is producing(b)(4)suitable for the intended uses for each of your products.A detailed risk assessment addressing the potential effects of the observed(b)(4)system failures on the quality of all drug product lots currently in U.S. distribution. Specify actions that you will take in response to the risk assessment, such as customer notifications and product recalls.A procedure for your(b)(4)system monitoring that specifies routine microbial testing of(b)(4)to ensure its acceptability for use in each batch of drug products produced by your firm.A procedure governing your program for ongoing control, maintenance, and monitoring that ensures the remediated system consistently produces(b)(4)that meets(b)(4), USP monograph specifications and appropriate microbial limits.Drug Production SuspendedWe acknowledge that you delisted your OTC drug product with FDA. In response to this letter, clarify whether you intend to resume manufacturing drugs 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 corrective actions and preventive actions (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. 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.See FDA’s guidance documentQuality Systems Approach to Pharmaceutical CGMP Regulationsfor help implementing quality systems and risk management approaches to meet the requirements of CGMP regulations 21 CFR, parts 210 and 211 at https://www.fda.gov/media/71023/download.Cosmetics Manufactured for Distribution in the United StatesIn addition, we note that some of the products you manufacture may be regulated as cosmetics, as defined in section 201(i) of the FD&C Act [21 U.S.C. 321(i)]. Any cosmetics you manufacture must comply with applicable statutory and regulatory requirements, including the FD&C Act. Under section 301(a) of the FD&C Act [21 U.S.C. 331(a)], it is a prohibited act to introduce or deliver for introduction into interstate commerce a cosmetic that is adulterated or misbranded.Further, your facility may be subject to requirements of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). Information on MoCRA requirements may be found athttps://www.fda.gov/cosmetics/cosmetics-laws-regulations/modernization-cosmetics-regulation-act-2022-mocra.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. 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 Marshalls Traditional Healthcare CC, FEI 3014740544, at 560 Main Reef Road, Germiston, Gauteng 1400, South Africa, into the United States under section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3). Articles under this authority that appear to be adulterated may be detained or refused admission, in that the methods and controls used in their manufacture do not appear to conform to CGMP within the meaning of section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. 351(a)(2)(B).This letter notifies you of our findings and provides you an opportunity to address the above deficiencies. After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any violations and to prevent their recurrence. In response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion.Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 3014740544 and ATTN: Christopher M. Jenner.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and Research

Delivery Method:Via EmailReference #:320-25-39Product:DrugsRecipient:Mr. Manish GuptaManaging DirectorJagsonpal Pharmaceuticals LimitedPlot No. 412-415, Phase-IVUdyog ViharGurugram122015HaryanaIndiaIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter320-25-39February 5, 2025Dear Mr. Gupta:The U.S. Food and Drug Administration (FDA) inspected your registered facility, Jagsonpal Pharmaceuticals Limited, FEI 3004153045, located at B-1124, RIICO Industrial Area, Phase-III, Bhiwadi Dist., Alwar, Rajasthan, on March 20, March 27, and April 3, 2024.This warning letter summarizes significant deviations from Current Good Manufacturing Practice (CGMP) for APIs.Because the methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your API is 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).(b)(4)is not duly listed with FDA as required by section 510(j) of the FD&C Act. Failure to provide correct listing information required by section 510(j) 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). Introduction or delivery for introduction of such a product 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.We reviewed your April 22, 2024 response to our Form FDA 483 in detail, and acknowledge receipt of your subsequent correspondence.During our inspection, our investigator observed specific deviations including, but not limited to, the following.CGMP DeviationsFailure of your quality unit to exercise its responsibility to ensure the API manufactured at your contract facility is in compliance with CGMP.Your firm utilized a contract manufacturing organization (CMO),(b)(4), to perform manufacturing, processing, and packaging activities on your behalf. You received drugs from this CMO and declared your firm as the manufacturer on import records. Additionally, you registered your firm with the FDA(b)(4).(b)(4)is not registered as a drug manufacturer with the FDA.A written agreement with your CMO, provided during the inspection, describes the responsibilities of your firm in the manufacturing of(b)(4). For example, Jagsonpal personnel are responsible for supervising the manufacturing and analysis of(b)(4)and assuring your CMO adheres to CGMP.However, you did not adequately ensure that process validation was completed by your CMO, that master production instructions were complete, and that compendial methods used to analyze your product were appropriately verified as suitable for their intended use.Drugs must be manufactured in conformance with CGMP. FDA is aware that many drug manufacturers use independent contractors such as production facilities, testing laboratories, packagers, and labelers. 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. You are required to ensure that drugs are made in accordance with section 501(a)(2)(B) of the FD&C Act to ensure safety, identity, strength, quality, and purity. See FDA’s guidance documentContract Manufacturing Arrangements for Drugs: Quality Agreementsat https://www.fda.gov>media>download.Your firm’s quality systems are inadequate. See FDA’s guidance documentQuality Systems Approach to Pharmaceutical CGMP Regulationsfor help implementing quality systems and risk management approaches to meet the requirements of CGMP regulations 21 CFR, parts 210 and 211 at https://www.fda.gov/media/71023/download.In response to this letter, provideA comprehensive assessment and remediation plan for your QU oversight, including qualification of your contract manufacturers, to evaluate adherence to appropriate practices.Confirmation that your CMO,(b)(4), is registered with the FDA.Access to Information During InspectionOn March 15, 2024, the FDA arrived at the registered address, B-1124, RIICO Ind. Area, Phase-III, Bhiwadi Dist., Alwar, Rajasthan, 301019, India, to conduct an inspection and was refused entry by individuals present at this address.On March 20, 2024, the FDA was permitted to enter the facility at the registered address to conduct an inspection; however, access to requested documents was limited during the inspection. For example, complete analytical data, equipment logbooks, and change control documents were not provided upon request because, according to your representatives, the facility was in(b)(4)status. Representatives from Jagsonpal and your CMO were present during these requests.When an owner, operator, or agent delays, denies, limits, or refuses an inspection, the drugs may be deemed adulterated under section 501(j) of the FD&C Act. See FDA’s guidance document Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/circumstances-constitute-delaying-denying-limiting-or-refusing-drug-or-device-inspection.Establishment Registration and Drug Listing ViolationsUnder section 510 of the FD&C Act, 21 U.S.C. 360, and 21 CFR Part 207 of FDA regulations, firms that manufacture, prepare, propagate, compound, or process drugs in the United States or that are offered for import into the United States must be registered with the FDA. Every person who is required to register must, at the time of initial registration, list all drugs manufactured, prepared, propagated, compounded, or processed for commercial distribution under section 510(j)(1) of the FD&C Act, 21 U.S.C. 360(j)(1). Private label distributors who do not perform any manufacturing activities but distribute the products under their name and label are not required to register, but their products must be listed under their own labeler code. In addition, in accordance with section 510(j)(2) of the FD&C Act, 21 U.S.C. section 360(j)(2), and 21 CFR 207.57(b), registrants are required to submit updated drug listing information to the FDA twice each year, in June and December, notifying FDA if this information has changed.(b)(4)was manufactured at an unregistered facility,(b)(4), and was not listed by them as required under 21 CFR 207.41(a), thus causing(b)(4)to be misbranded under section 502(o) of the FD&C Act, 21 U.S.C. 352(o).For each drug bearing an NDC, the name of the establishment where the drug is manufactured in accordance with 21 CFR 207.49(a)(12) must be provided.(b)(4)does not include correct manufacturer information in the listing and includes Jagsonpal Pharmaceuticals Ltd. as the manufacturer instead of(b)(4). You should include(b)(4)in your product listing as the manufacturer of(b)(4). Therefore,(b)(4)is not compliant as required by section 510(j) of the FD&C Act while in commercial distribution, rendering this drug 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 current 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).It remains your responsibility to ensure that(b)(4)and all products manufactured at any of your establishments or distributed under your name and label comply with all registration and listing requirements under section 510 of the FD&C Act, 21 U.S.C. 360, and 21 CFR Part 207 of FDA regulations. Registration and listing information and instructions on how to properly register an establishment or submit drug listings can be found at Electronic Drug Registration and Listing Instructions | FDA.Additional API CGMP GuidanceFDA considers the expectations outlined in ICH Q7 when determining whether APIs are manufactured in conformance with CGMP. See FDA’s guidance documentQ7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredientsfor guidance regarding CGMP for the manufacture of API at https://www.fda.gov/media/71518/download.CGMP Consultant RecommendedBased upon the nature of the deviations we identified, you should engage a consultant qualified to evaluate your operations and to assist your firm in meeting CGMP requirements. The qualified consultant should also perform a comprehensive audit of your entire operation for CGMP compliance and evaluate the completion and efficacy of your 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 deviations cited in this letter are not intended to be an all-inclusive list. You are responsible for investigating and determining the causes of any deviations and for preventing their recurrence or the occurrence of other deviations.FDA placed products offered for import into the United States from your firm on Import Alert 66-40 on January 17, 2025.Correct any deviations promptly. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any deviations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to any deviations.Failure to address any deviations may also result in the FDA continuing to refuse admission of articles manufactured by Jagsonpal Pharmaceuticals, or listing the address B-1124, RIICO Ind. Area, Phase-III, Bhiwadi Dist., Alwar, Rajasthan, 301019, India, as the manufacturer, 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 or misbranded 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) and are misbranded under section 502 of the FD&C Act, respectively.This letter notifies you of our findings and provides you an opportunity to address the above deficiencies. After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any deviations and to prevent their recurrence. In response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion.Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 3004153045 and ATTN: Maria Pavco.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 ComplianceCenter for Drug Evaluation and Research

Delivery Method:Via EmailReference #:320-25-41Product:DrugsRecipient:Mr. Sandeep GokarajuOwner and DirectorTyche Industries Ltd6-223, Sarpavaram (V)Kakinada533005Andhra PradeshIndiasandeepraju@tycheindustries.netIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter320-25-41February 6, 2025Dear Mr. Gokaraju:The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Tyche Industries Ltd, FEI 3004790309, at 6-223, Sarpavaram (V), Kakinada, from August 12 to 16, 2024.This warning letter summarizes significant deviations from Current Good Manufacturing Practice (CGMP) for active pharmaceutical ingredients (APIs).Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your APIs are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).We reviewed your September 4, 2024 response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence.During our inspection, our investigator observed specific deviations including, but not limited to, the following.1. Failure to record all quality-related activities at the time they are performed.Your quality unit (QU) failed to ensure the integrity of CGMP records. For example, during the inspection, a member of your management stated that two of your operators admitted to falsifying temperature data for a drying oven that was not turned on during the manufacture of a(b)(4)batch, which later failed to meet the residual solvents specification. In addition, an Assistant Manager in Production, an Assistant Manager in Quality Assurance, and a Quality Control Manager admitted to participating in the preparation of a “backdated calculation sheet” that was given to our investigator.Your documentation practices were not indicative of a facility that is in compliance with CGMP.Your response is inadequate. You state that you plan to hire a consultant to identify data integrity gaps and prepare and implement an action plan by June 30, 2025, approximately ten months from the conclusion of the inspection, which documented serious questionable data integrity practices. In addition, you state that you removed some of the employees involved in these incidents from CGMP-related activities, but you do not explain what was done to prevent the other employees involved in these activities from further data integrity deviations. Finally, you do not fully evaluate the scope of data integrity lapses at your firm, including by interviewing current and former employees and comprehensively reviewing data records.Significant findings in this letter indicate that your QU is not fully exercising its authority and/or responsibilities. Your firm must provide the QU with the appropriate authority and sufficient resources to carry out its responsibilities and consistently ensure drug quality. For guidance on establishing and maintaining CGMP-compliant quality systems, see FDA’s guidances:Q8(R2) Pharmaceutical Developmentat https://www.fda.gov/media/71535/download,Q9 Quality Risk Managementat https://www.fda.gov/media/167721/download andQ10 Pharmaceutical Quality Systemathttps://www.fda.gov/media/71553/download.In your response to this letter, provide:A comprehensive assessment and remediation plan to ensure your QU is given the authority and resources to effectively function. The assessment should also include, but not be limited to:o A determination of whether procedures used by your firm are robust and appropriate.o Provisions for QU oversight throughout your operations to evaluate adherence to appropriate practices.o A complete and final review of each batch and its related information before the QU disposition decision.o Oversight and approval of investigations and discharging of all other QU duties to ensure identity, strength, quality, and purity of all products.A complete assessment of documentation systems used throughout your manufacturing and laboratory operations to determine where documentation practices are insufficient. Include a detailed corrective action and preventive action (CAPA) plan that comprehensively remediates your firm’s documentation practices to ensure you retain attributable, legible, complete, original, accurate, contemporaneous records throughout your operation.2. Failure to clean equipment and utensils to prevent contamination or carry-over of a material that would alter the quality of the APIs beyond the official or other established specifications.FDA documented rust-like residues inside(b)(4)non-dedicated(b)(4)used in the production of(b)(4). In addition, FDA documented bare footprints inside another(b)(4)used in the production of(b)(4). Each(b)(4)was labeled that it had been cleaned and was ready for use.Inadequately cleaned and maintained manufacturing equipment can lead to potential cross- contamination that could compromise your API’s quality and safety.Your response is inadequate. You state that you reviewed the quality of the products manufactured in the impacted equipment since February 2024, but you do not describe how you conducted this review, nor the reason you limited your review to this timeframe. In addition, you do not adequately explain how you will prevent the failure to clean equipment after personnel enter inside it from recurring. Finally, you state that personnel entering inside equipment should “wear cloth shoe cover after removing shoe,” but failing to wear suitable clothing, including appropriate footwear, poses an unacceptable risk to the product.In your response to this letter, provide:Your CAPA plan to implement routine, vigilant operations management oversight of facilities and equipment. This plan should ensure, among other things, prompt detection of equipment/facilities performance issues, effective execution of repairs, adherence to appropriate preventive maintenance schedules, timely technological upgrades to the equipment/facility infrastructure, and improved systems for ongoing management review.A comprehensive, independent retrospective assessment of your cleaning effectiveness to evaluate the scope of cross-contamination hazards. Include the identity of residues, other manufacturing equipment that may have been improperly cleaned, and an assessment whether cross-contaminated products may have been released for distribution. The assessment should identify any inadequacies of cleaning procedures and practices, and encompass each piece of manufacturing equipment used to manufacture more than one product.Your CAPA plan, based on the retrospective assessment of your cleaning program, that includes appropriate remediations to your cleaning processes and practices, and timelines for completion. Provide a detailed summary of vulnerabilities in your process for lifecycle management of equipment cleaning. Describe improvements to your cleaning program, including enhancements to cleaning effectiveness; improved ongoing verification of proper cleaning for all products and equipment; and all other needed remediations.3. Failure to test the identity of each batch of incoming production material.Your incoming raw material used to manufacture API intended for the U.S. market was not adequately tested. For example, you did not test the(b)(4)used as a raw material in the production of(b)(4)for identity.Your response is inadequate. You state that you “initiated the activity” to test(b)(4)for identity. However, you do not address whether all other raw materials are tested for identity or how you will prevent this deviation from recurring with new raw materials.In your response to this letter, provide:A comprehensive, independent review of your material system to determine whether all suppliers of raw materials, 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 raw materials, containers, and closures.The chemical and microbiological quality control specifications you use to test and release each incoming batch of raw material for use in manufacturing.A description of how you will test each raw material batch for conformity with all appropriate specifications for identity, strength, quality, and purity. If you intend to accept any results from your supplier’s certificates of analysis (COAs) instead of testing each raw material batch 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 raw material batch.A summary of results obtained from testing all raw materials to evaluate the reliability of the COA from each raw material manufacturer. Include your standard operating procedure that describes this COA validation program.A summary of your program for qualifying and overseeing contract facilities that test the drug products you manufacture.Data Integrity RemediationYour quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture. See FDA’s guidance documentData Integrity and Compliance With Drug CGMPfor guidance on establishing and following CGMP compliant data integrity practices athttps://www.fda.gov/media/119267/download.We strongly recommend that you retain a qualified consultant to assist in your remediation. In response to this letter, provide:A comprehensive investigation into the extent of the inaccuracies in data records and reporting including results of the data review for drugs distributed to the United States. Include a detailed description of the scope and root causes of your data integrity lapses.A current risk assessment of the potential effects of the observed failures on the quality of your drugs. Your assessment should include analyses of the risks to patients caused by the release of drugs affected by a lapse of data integrity and analyses of the risks posed by ongoing operations.A management strategy for your firm that includes the details of your global CAPA plan. The detailed corrective action plan should describe how you intend to ensure the reliability and completeness of all data generated by your firm including microbiological and analytical data, manufacturing records, and all data submitted to FDA.ConclusionThe deviations cited in this letter are not intended to be an all-inclusive list of deviations that exist at your facility. You are responsible for investigating and determining the causes of any deviations and for preventing their recurrence or the occurrence of other deviations.FDA placed products offered for import into the United States from your firm on Import Alert 66-40 on January 2, 2025.Correct any deviations promptly. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any deviations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to any deviations.Failure to address any deviations may also result in the FDA continuing to refuse admission of articles manufactured at Tyche Industries Ltd in Kakinada, into the United States under section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3). Articles under this authority that appear to be adulterated may be detained or refused admission, in that the methods and controls used in their manufacture do not appear to conform to CGMP within the meaning of section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. 351(a)(2)(B).This letter notifies you of our findings and provides you an opportunity to address the above deficiencies. After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any deviations and to prevent their recurrence. In response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion.Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 3004790309 and ATTN: Russell Riley.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and Research

Delivery Method:VIA UPSReference #:320-25-36Product:DrugsRecipient:Ms. Ijyahu Raphe EzeOwnerAmWiner & Raphe Holdings, LLC dba rapheGenerics Corp802 East Walnut StreetGarland,TX75040United StatesIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter320-25-36January 29, 2025Dear Ms. Eze:The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, AmWiner & Raphe Holdings LLC, FEI 3009569638, at 11601 Plano Road Suite 104, Dallas, Texas 75243, from June 20 to August 7, 2024.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, “MEN’S LIFECELL HAIR RESTORATION SOLUTION HAIR REGROWTH TREATMENT EXTRA STRENGTH” and “WOMENS LIFECELL 2% MINOXIDIL TOPICAL SOLUTION USP HAIR REGROWTH TREATMENT” drug products are unapproved new drugs introduced or delivered for introduction into interstate commerce in violation of section 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d). These violations are described in more detail below.We reviewed your August 21, 2024 response to our Form FDA 483 in detail.CGMP ViolationsDuring our inspection, our investigator observed specific violations including, but not limited to, the following.1. Your firm failed to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release (21 CFR 211.165(a)).Your firm manufactures topical over-the-counter (OTC) drug products, including drug products that contain the active ingredient minoxidil. You failed to establish adequate release testing procedures or specifications for your OTC drug products, and accordingly released batches of drug products for distribution without conducting adequate testing to confirm critical quality attributes.In your response, you state that your finished product testing will be performed by a contract laboratory. Your response is inadequate. You did not describe how you will ensure that your finished products meet appropriate quality standards prior to release. You also did not consider a detailed risk assessment addressing the potential effects of releasing drug product to the market without established specifications to ensure their identity, strength, quality, and purity.Full release testing, including strength and identity testing of the active ingredient, must be performed before drug product release and distribution. Without adequate testing, you do not have adequate scientific evidence to assure that your drug products conform to appropriate specifications before release.In response to this letter, provide:A list of chemical and microbial specifications, including test methods, used to analyze each lot of your drug products before a batch disposition decision.o An action plan and timelines for conducting full chemical and microbiological testing of retain samples to determine the quality of all batches of drug product distributed to the United States that are within expiry as of the date of this letter.o A summary of all results obtained from testing retain samples from each batch. If such testing reveals substandard quality drug products, take rapid corrective actions, such as notifying customers and product recalls.2. Your firm failed to establish 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, and your firm’s quality control unit did not review and approve those procedures, including any changes (21 CFR 211.100(a)).Your firm failed to complete equipment and process performance qualification (PPQ) prior to releasing your OTC drug products. Likewise, you lacked appropriate documentation, qualification, maintenance, and monitoring of your purified water system, which is used in the manufacture of your OTC drug products.In your response, you state that procedures have been established to monitor and validate the performance of your manufacturing processes including qualifying all manufacturing equipment. You also commit to testing your purified water before it used in any manufacturing process.Your response is inadequate as you did not provide sufficient information (such as validation protocols, reports, or timelines) to establish that your equipment and processes are adequately qualified and validated. Further, information, such as sampling procedures, testing procedures, method validation, or routine monitoring results, were not provided to support that your purified water system is adequately monitored and maintained.In response to this letter, provide:A remediation plan that better assures ongoing management oversight throughout the manufacturing lifecycle of all drug products. Provide a more data-driven and scientifically sound program that identifies sources of process variability, and assures that manufacturing (including both production and packaging) operations meet appropriate parameters and quality standards. This includes, but is not limited to, evaluating suitability of equipment for its intended use, ensuring quality of input materials, determining the capability and reliability of each manufacturing process step and its controls, and vigilant ongoing monitoring of process performance and product quality.A detailed summary of your validation program for ensuring a state of control throughout the product lifecycle, along with associated procedures. Describe your program for PPQ and ongoing monitoring of both intra-batch and inter-batch variation to ensure a continuing state of control.A timeline for performing PPQ for each of your marketed drug products.Process performance protocol(s), and written procedures for qualification of equipment and facilities.A detailed program for designing, validating, maintaining, controlling and monitoring each of your manufacturing processes that includes vigilant monitoring of intra-batch and inter-batch variation to ensure an ongoing state of control. Also, include your program for qualification of your equipment and facility.A comprehensive remediation plan for the design, control, and maintenance of the water system.o A purified 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.A procedure for your water system monitoring that specifies routine microbial testing of water to ensure its acceptability for use in each batch of drug products produced by your firm.The current action/alert limits for total counts and objectionable organisms used for your purified water system. Ensure that the total count limits for your purified water are appropriately stringent in view of the intended use of each of the products produced by your firm.A procedure governing your program for ongoing control, maintenance, and monitoring that ensures the system consistently produces water that meets Purified Water, USP monograph specifications and appropriate microbial limits.3. 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)).You failed to adequately test your incoming components, including propylene glycol and active ingredients such as minoxidil, for identity before using them in the manufacture of your OTC drug products. Additionally, you relied on your suppliers’ certificates of analysis (COAs) without establishing the reliability of each of your suppliers’ analyses at appropriate intervals.Propylene GlycolYou failed to adequately test each shipment of each lot of propylene glycol for identity, components at higher risk for diethylene glycol (DEG) and ethylene glycol (EG) contamination. Identity testing for glycerin, propylene glycol, and certain other high-risk drug components1includes a limit test in the United States Pharmacopeia (USP) to ensure that the component meets the relevant safety limits for levels of DEG or EG. Because you did not perform adequate 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 manufacture of your drug product.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 “full compendial” testing of raw materials will be performed by a contract laboratory. You also state that propylene glycol will be tested for DEG impurities before use in manufacturing, and that your firm will no longer depend on the manufacturer's COA for propylene glycol and minoxidil. Your response is inadequate. You did not provide a detailed plan for how components will be tested, including test methods and review of compendial requirements, or a timeline for implementing the corrective actions proposed. Additionally, you did not describe how you plan to establish the reliability of the test results on your suppliers’ COAs at appropriate intervals. Further, you did not consider testing retains of raw materials or a retrospective review of previously distributed OTC drug products.Without adequate testing, you do not have appropriate assurance that components conform to appropriate specifications prior to use in the drug products you manufacture.In response to this letter, provide: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 lots 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, propylene glycol). 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 that secure supply chains in the future, including, but not limited to, ensuring that all incoming raw material lots are from fully qualified manufacturers and free from unsafe impurities. Detail these actions in your response to this letter.A description of how you will test each component lot for conformity with all appropriate specifications for identity, strength, quality, and purity. If you intend to accept any results from your supplier’s COA instead of testing each component lot for strength, quality, and purity, specify how you will robustly establish the reliability of your supplier’s results through initial validation as well as periodic revalidation. In addition, include a commitment to always conduct at least one specific identity test for each incoming component lot. In the case of glycerin, propylene glycol, and certain additional high-risk components we note that this includes the performance of parts A, B, and C of the USP monograph.The chemical and microbiology quality control specifications you use to test each incoming lot of each incoming lot of components, including, high-risk drug components to determine acceptability for use in manufacturing.A comprehensive, independent review of your material system to determine whether all suppliers of components, containers, and closures, are each qualified and the materials are assigned appropriate expiration or retest dates. The review should also determine whether incoming material controls are adequate to prevent use of unsuitable components, containers, and closures.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 that describes this COA validation program.A summary of your program for qualifying and overseeing contract facilities that test the drug products you manufacture.Quality SystemsYour firm’s quality systems are inadequate. See FDA’s guidance documentQuality Systems Approach to Pharmaceutical CGMP Regulationsfor help implementing quality systems and risk management approaches to meet the requirements of CGMP regulations 21 CFR, parts 210 and 211 at https://www.fda.gov/media/71023/download.Unapproved New Drug Violations“MEN’S LIFECELL HAIR RESTORATION SOLUTION HAIR REGROWTH TREATMENT EXTRA STRENGTH” and “WOMENS LIFECELL 2% MINOXIDIL TOPICAL SOLUTION USP HAIR REGROWTH TREATMENT” are drugs as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because they are 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 they are intended to affect the structure or any function of the body.Examples from the “MEN’S LIFECELL HAIR RESTORATION SOLUTION HAIR REGROWTH TREATMENT EXTRA STRENGTH” and “WOMENS LIFECELL 2% MINOXIDIL TOPICAL SOLUTION USP HAIR REGROWTH TREATMENT” product labeling that provide evidence of the intended uses (as defined in 21 CFR 201.128) of the products as drugs include, but may not be limited to, the following:“MEN’S LIFECELL HAIR RESTORATION SOLUTION HAIR REGROWTH TREATMENT EXTRA STRENGTH”“HAIR REGROWTH TREATMENT EXTRA STRENGTH” [from the product label]“Uses· Relieves scalp itching, irritation, redness, flaking and scaling due to seborrheic dermatitis · Helps eliminate recurrence of seborrheic dermatitis” [from the product label]“Help hair loss and regrow fuller hair with LifeCell Extra Strength Hair Regrowth Treatment. This fast-working hair loss treatment is clinically proven to regrow up to 25% more hair. Unlike hair loss shampoos and hair thickening products that temporarily plump hair from the outside, LifeCell penetrates the scalp to reactivate shrunken hair follicles. The Minoxidil formula works to boost hair follicle activity and hair protein production, allowing for regrowth of hair. This hair thinning treatment comes in a topical solution that is easy to use: Simply apply 1 milliliter directly to your scalp twice daily and massage it through your hair.” [from the product website https://www.lifecellskin.com/]“WOMENS LIFECELL 2% MINOXIDIL TOPICAL SOLUTION USP HAIR REGROWTH TREATMENT”“HAIR REGROWTH TREATMENT” [from the product label]“Reactivates Hair Follicles To Stimulate Regrowth” [from the product label]“Uses· Relieves scalp itching, irritation, redness, flaking and scaling due to seborrheic dermatitis · Helps eliminate recurrence of seborrheic dermatitis” [from the product label]“Help hair loss and regrow fuller hair with LifeCell Extra Strength Hair Regrowth Treatment. This fast-working hair loss treatment is clinically proven to regrow up to 25% more hair. Unlike hair loss shampoos and hair thickening products that temporarily plump hair from the outside, LifeCell penetrates the scalp to reactivate shrunken hair follicles. The Minoxidil formula works to boost hair follicle activity and hair protein production, allowing for regrowth of hair. This hair thinning treatment comes in a topical solution that is easy to use: Simply apply 1 milliliter directly to your scalp twice daily and massage it through your hair.” [from the product website https://www.lifecellskin.com/]Unapproved New Drug ViolationsBased on the above labeling evidence, “MEN’S LIFECELL HAIR RESTORATION SOLUTION HAIR REGROWTH TREATMENT EXTRA STRENGTH” and “WOMENS LIFECELL 2% MINOXIDIL TOPICAL SOLUTION USP HAIR REGROWTH TREATMENT” are intended for use as OTC hair grower drug products, among other intended uses.2As described below, these drugs products are unapproved new drugs marketed in violation of sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d).As stated above, “MEN’S LIFECELL HAIR RESTORATION SOLUTION HAIR REGROWTH TREATMENT EXTRA STRENGTH” and “WOMENS LIFECELL 2% MINOXIDIL TOPICAL SOLUTION USP HAIR REGROWTH TREATMENT” are OTC hair grower drug products. According to 21 CFR 310.527(b), any OTC drug product that is labeled, represented, or promoted for external use as a hair grower or for hair loss prevention is regarded as a new drug within the meaning of section 201(p) of the FD&C Act, for which an approved new drug application under section 505 of the FD&C Act is required for marketing.“MEN’S LIFECELL HAIR RESTORATION SOLUTION HAIR REGROWTH TREATMENT EXTRA STRENGTH” and “WOMENS LIFECELL 2% MINOXIDIL TOPICAL SOLUTION USP HAIR REGROWTH TREATMENT” are not generally recognized as safe and effective (GRASE) for its above referenced uses and, therefore, are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p). Subject to certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a). No FDA-approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355 are in effect for these products.Accordingly, “MEN’S LIFECELL HAIR RESTORATION SOLUTION HAIR REGROWTH TREATMENT EXTRA STRENGTH” and “WOMENS LIFECELL 2% MINOXIDIL TOPICAL SOLUTION USP HAIR REGROWTH TREATMENT” are unapproved new drugs marketed in violation of section 505(a) of the FD&C Act, 21 U.S.C. 355(a). Introduction or delivery for introduction of these products into interstate commerce violates section 301(d) of the FD&C Act, 21 U.S.C.331(d).ConclusionThe violations cited in this letter are not intended to be an all-inclusive list of violations that exist in connection with your products. 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 3009569638 and ATTN: Christina Capacci-Daniel.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 ComplianceCenter for Drug Evaluation and Research______________________1Components with higher risk of DEG or EG contamination compared to other drug components.2We note that “MEN’S LIFECELL HAIR RESTORATION SOLUTION HAIR REGROWTH TREATMENT EXTRA STRENGTH” and “WOMENS LIFECELL 2% MINOXIDIL TOPICAL SOLUTION USP HAIR REGROWTH TREATMENT” also appear to be indicated to control seborrheic dermatitis. OTC control of seborrheic dermatitis drug products are deemed to be generally recognized as safe and effective (GRASE) and not new drugs if, among other things, they conform to the conditions of use set forth in the final administrative order, Over-the-Counter Monograph M032: Drug Products for the Control of Dandruff, Seborrheic Dermatitis, and Psoriasis for Over-the-Counter Human Use (M032). These products do not conform to the conditions set forth in this monograph. “MEN’S LIFECELL HAIR RESTORATION SOLUTION HAIR REGROWTH TREATMENT EXTRA STRENGTH” and “WOMENS LIFECELL 2% MINOXIDIL TOPICAL SOLUTION USP HAIR REGROWTH TREATMENT” are labeled as both external use hair growth and control of seborrheic dermatitis drug products. These products cannot meet the requirement of M032 because hair growth claims go beyond the intended use claims permitted in M032. Additionally, minoxidil, is not a permitted active ingredient in M032. Although the Drug Facts Panels of these products do not specifically list this ingredient as an active ingredient, the website’s statements describing the pharmacological activity of the ingredient along with the prominence of this ingredient demonstrate that it is an “active ingredient” as defined in 21 CFR 201.66(b)(2) because it is intended to furnish pharmacological activity (under 21 CFR 201.66(b), an active ingredient is a component of a drug intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or function of the body).

Delivery Method:Via EmailReference #:320-25-42Product:DrugsRecipient:Mr. Jorge D. AbraldesCEOABR Laboratory LLC450 N Park Rd, Suite 303Hollywood,FL33021-6917United StatesIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter320-25-42February 10, 2025Dear Mr. Abraldes:The U.S. Food and Drug Administration (FDA) inspected your contract testing laboratory, ABR Laboratory LLC., FEI 3020570829, located at 450 North Park Road, Suite 303, Hollywood, FL 33021-6917, from September 9 to 13, 2024.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, the drug products you tested are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).We reviewed your September 29, 2024 response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence.During our inspection, our investigator observed specific violations including, but not limited to, the following.1. Your firm failed to establish and document the accuracy, sensitivity, specificity, and reproducibility of its test methods (21 CFR 211.165(e)).Your firm is a contract testing lab that analyzes drugs for your customers. You did not use a suitable method to test your client’s over-the-counter (OTC) drug products. For example, your method was not verified to be equivalent or better than the United States Pharmacopeia (USP) method used to test multiple OTC) drug products for potential microbial contamination. Your method for Plate Count(b)(4)growth media is different in composition to the Soybean-Casein Digest Agar required for plate count methods by USP Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests. You have not demonstrated your method is equivalent or better than the USP compendial method. Additionally, you failed to perform method suitability for the microbial testing of(b)(4)and(b)(4)OTC drug products. The(b)(4)drug product is intended for(b)(4)symptoms in children.Method suitability testing ensures the method can reliably determine the presence of microbial growth in the drug product. Without evaluating the validity of methods, you lack assurance that the data provided to customers was an accurate reflection of pharmaceutical drug product quality and safety.In your response you state you “have initiated a comprehensive validation of Test Method STP-002 Microbiological Testing of Raw Materials and Products” and “will conduct a suitability test for each product category.”Your response is inadequate. You do not provide sufficient information to demonstrate that your methods are equivalent or better than the applicable USP compendial methods and suitable for their intended use. In addition, you state you will develop methods for each drug category; however, you do not provide data supporting your method for each product category is suitable for each individual drug product.Responsibilities of Contract Testing LabFDA considers contractors as extensions of the manufacturer’s own facility. Your failure to comply with CGMP may affect the quality, safety, and efficacy of the drugs you test for your clients. It is essential that you understand your responsibility to operate in full compliance with CGMP, and that you inform all your customers of any out-of-specification (OOS) results or significant problems encountered during the testing of these drugs.In response to this letter, provide:A comprehensive independent assessment of your laboratory practices, procedures, methods, equipment, documentation, and analyst competencies. Based on this review, provide a detailed plan to remediate and evaluate the effectiveness of your laboratory system.A retrospective review to determine the scope and the impact of the violation. The review should include a procedure to re-test drug product potentially affected by the violation and a procedure that details steps you will take in the case previously negative results are shown to be positive for microbial contamination, including notifying your customers.Updated procedures documenting how the suitability of all test methods will be determined, when method verification and validation occur, and corresponding training records.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).You failed to investigate out-of-range deviations in temperature and humidity readings in your laboratory equipment. For example, your 2 - 8°C refrigerator was out of range for more than 24 hours reaching temperatures of up to 17.4°C. This refrigerator houses the reference microorganisms used in your growth promotion tests. This deviation was not identified or investigated. Storing of reference microorganisms outside of their acceptable range compromises their ability to grow, thereby undermining their value as reference organisms and the accuracy of the results.In your response, you state you will update your relevant procedures. You also commit to implementing a real-time monitoring system to alert staff of any temperature deviations.Your response is inadequate. You fail to investigate the deviation to determine the scope and potential impact to the accuracy of your test results and you fail to identify a root cause to correct and prevent recurrence. You also do not commit to evaluating other laboratory and manufacturing equipment and their related procedures to ensure deviations are identified and investigated.In response to this letter, provide 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, corrective action and preventive action effectiveness, quality unit oversight, and written procedures. Address how your firm will ensure all phases of investigations are appropriately conducted.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.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 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.Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 3020570829 and ATTN: Carlos Gonzalez.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and Research

Delivery Method:Via EmailProduct:Medical DevicesRecipient:Phu N. NguyenManager/OwnerRobbins Instruments, LLC2003 Edwards StreetHouston,TX77007United States(b)(6)@robbinsinstruments.comIssuing Office:"ORP: Office of Regulatory Programs, Office of Product Evaluation and Quality"United StatesCenter for Devices and Radiological HealthUnited StatesWARNING LETTERCMS #687984January 21, 2025Dear Mr. Nguyen:During an inspection of your firm located at 2003 Edwards Street, Houston, TX 77007, FEI 2221941, on March 27 through May 31, 2024, an investigator from the United States Food and Drug Administration (FDA) determined that your firm is a manufacturer and distributor of the Dermo-Jet Needleless Injector. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), this product is a device because it is 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.Unapproved Device ViolationFDA has learned that your firm is marketing the Dermo-Jet Needleless Injector without marketing clearance or approval, in violation of the Act. FDA has determined, based on information provided by your firm that the Dermo-Jet Needleless Injector is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption under section 520(g) of the Act, 21 U.S.C. § 360j(g). The device is also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the device into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k).Specifically, the instructions for use document for the Dermo-Jet Needleless Injector included in the company’s SOP document provided during the referenced inspection outlines the following indications: “The DERMO-JET is a versatile, time-tested, medical instrument for administration of sub-topical injections of parenteral medicaments, anesthetic solutions, steroids in aqueous suspension, soluble drugs, vaccines, antibiotics, etc.” In addition, the Robbins Instruments brochure for the DERMO-JET collected during the referenced inspection, includes many specific claims, as provided below:•“Painless Uses – A local Anesthetic prior to an injection using a syringe with a needle or a puncture (lumbar, pleural, articular, sternal, etc).•Intradermic Injections and Tests – The reading of the result of the test is clear due to the absence of any secondary infection which might be caused by a needle.•Intradermic Vaccinations – BCG, Anti-cholera, Tetanus, Diphtheria, Whooping Cough, Measles.•Mesotherapy – Needleless injection can be given for intradermic treatment, local anesthetics or in connection with reflexology.•Dermatology – This method can be used for in situ injections in the treatment of alopecia, psoriasis, keloids and hypertrophic scars, sclerosis, keratosis, acne, etc.•Phlebology – Anesthetics prior to a thrombectomy and before hardening injections.•Urology – The treatment of Peyronie’s disease.•Proctology – The treatment of hemorrhoids.•Gynecology – Needleless injections of progesterone to regularize the ovarian cycles.•Minor Surgery – Painless suturing. By making contiguous papules one produces linear zones of anesthetic which help incision with a bistouri.•Miscellaneous Uses – Acupuncture, sports medicine, aesthetic medicine, etc.”For a device requiring premarket approval, the notification required by section 510(k) is deemed satisfied when a PMA is pending before the agency. [21 CFR 807.81(b)] The kind of information that your firm needs to submit in order to obtain approval or clearance for the device is described on the Internet athttp://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.FDA requests that Robbins Instruments, LLC cease any activities that result in the misbranding or adulteration of the Dermo-Jet Needleless Injector, such as the commercial distribution of the devices for the uses discussed above., including selling to initial importers, distributors, or other third parties for distribution and use within the United States or otherwise representing these devices to have the requisite clearance or authorization for marketing in the United States.Quality System Regulation ViolationsOur inspection revealed that these devices are adulterated within the meaning of 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 are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at Title 21,Code of Federal Regulations(CFR), Part 820.We received responses from Danny Nguyen, Manager/Owner on June 21, 2024, July 18, 2024, and August 15, 2024, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, that was issued to your firm. We address these responses below, in relation to each of the noted violations. These violations include, but are not limited to, the following:1.Failure to review, evaluate and document the process and perform revalidation when changes or process deviations occurs, as required by 21 CFR 820.75(c).Specifically, your firm did not revalidate the changes made to your Dermo-Jet Needleless Injector Moist Heat Sterilization Method. You changed the sterilization process parameters from134°C for 18 minutesto121°C/250°F for 30 minutesor132°C/270°F for 4 minutesas identified in your product labeling IFU which you provide as cleaning and sterilization instructions to your customers. On August 23, 2019, your OEM Manufacturer validated the moist heat sterilization method under Study No. 1907-421 at134°C for 18 minutesbut you altered the temperature and time limits without conducting revalidation of your new sterilization parameters. You have distributed approximately 400 Dermo-Jet Needleless Injectors to your customers with the updated cleaning and sterilization instructions. In addition, you have not established a process validation procedure required under 21 CFR Part 820.75(b). We reviewed your firm’s responses and conclude that it is not adequate. Your firm submitted the sterilization validation report (High-power Study No. 1907-421) and a document change request form (DCR-01) dated 6/27/24 aimed at updating your moist heat sterilization specification to conform with the original sterilization parameters established by AKRA. It appears your firm has reverted to the moist heat sterilization parameters validated under study 1907-421, however, you have not addressed “Drying Time at minimum of 10 minutes” added to your Dermo-Jet Cleaning and Sterilization Sheet. In response to this letter, please provide updates and supporting documentation of your corrective actions as they are implemented.2.Failure to adequately establish design change procedures, as required by 21 CFR 820.30(i).Specifically, your firm has not established a design change procedure. Your firm updated the sterilization instruction in your instruction for use (IFU) without identification, documentation, validation or where appropriate verification, review and approval of design changes before their implementation.We reviewed your firm’s responses and conclude that it is not adequate. Your firm provided Biological Risk Assessment for the Dermo-jet HR (DOC ID BRA-0004-V1-EN-DEMJ) and a document change request (Form DCR-01); however, your firm has not provided design change procedures to ensure all your design change requirements can be met. In response to this letter, please provide updates and supporting documentation of your corrective actions as they are implemented.3.Failure to review, evaluate, and investigate complaints involving the possible failure of a device to meet any of its specifications where necessary, as required by 21 CFR 820.198(c).Specifically, your firm has not established a complaint handling procedure. Our investigator reviewed 31 complaint files and 23 of them were associated with failures of your Dermo-Jet Needleless Injectors in administering local anesthesia through intra-dermal injection to patients. For example, complaint/repair forms (SN45139, SN43812, and SN43824) pertain to your device failing to fire, penetrate, or inject medication as intended during operation. Your firm replaced the devices citing normal wear and tear from usage without investigating to determine whether the device, labeling, or its packaging failed to meet the product specifications.We reviewed your firm’s responses and conclude that it is not adequate. Your firm submitted procedures for Medical Device Reporting requirements (Doc. No. MDRR0.001, Rev. 001) and the Complaint/Repair Form (ROB-25). However, your procedure focuses on MDR reporting and does not incorporate a complaint handling process as required by 21 CFR 820.198. You have not provided corrections pertaining to your device’s failure to deliver medication as intended. You have not indicated your intention to conduct retrospective review of complaints to determine if an investigation is needed. In response to this letter, please provide updates and supporting documentation of your corrective actions as they are implemented.4.Failure to establish device history record to demonstrate that the device was manufactured in accordance with the device master record, as required by 21 CFR 820.184.Specifically, your firm has not established procedures to ensure that device history records (DHRs) are properly maintained. Your firm stated the invoices of the assembled/manufactured Dermo-Jet Needleless Injectors are your DHR. These invoices do not have the DHR elements outlined in Part 820.184, such as date of manufacture, quantity manufactured, quantity released for distribution, acceptance records, primary identification label and labeling used for production units. For example, your Dermo-Jet Needleless Injector acceptance records does not include testings performed such as rapidity, dosage size, reservoir capacity, weight, dimensions, etc. prior to final release. Your Dermo-Jet Design Specifications Sheet (#20) have these settings documented as design requirements for the proper functioning of your device.We reviewed your firm’s responses and conclude that it is not adequate. Your firm provided a Device History Record procedure (Doc. No. DHR.001, Rev. 001), however, there is no reference to acceptance records, such as testing for rapidity, dosage size, reservoir capacity, weight, and dimensions, to ensure device is manufactured in accordance with the DMR. In response to this letter, please provide updates and supporting documentation of your corrective actions as they are implemented.5.Failure to adequately document and maintain acceptance activities as part of the device history record, as required by 21 CFR 820.80(e).Specifically, your firm has not established procedures for acceptance activities such that inspections, tests, or other verification activities are performed to ensure compliance with specified requirements. The acceptance activities for receiving, in-process, and finished device acceptance are not documented in the DHR. For example, in-process activities such as the Ultrasonic Cleaner and Dryer Instrument times are not documented as stated by your Service Technicians and per your Dermo-Jet Assembly Procedure (#06). This equipment has not been validated.We reviewed your firm’s responses and conclude that it is not adequate. Your firm provided your Acceptance Activity procedure (Doc. No. AAP.001, Ver. 001) outlining the process for accounting, verifying, and inspecting all incoming components. This procedure applies to components used to assemble or repair a Dermo-Jet device, but it does not adequately include provisions for inspection, testing, or other verification activities pertaining to finished devices. In response to this letter, please provide updates and supporting documentation of your corrective actions as they are implemented.6.Failure to establish procedures to control labeling activities, as required by 21 CFR 820.120.Specifically, your firm failed to define the requirements for conducting labeling reviews and overseeing labeling activities in your Labeling and Packing procedure (#10). For example, your procedure does not define how labels are printed and applied to remain legible and affixed during processing, storage, handling, and distribution; it does not define label/labeling inspection and release criteria; and it does not include labeling storage requirements for proper identification and is designed to prevent mix-ups. Your employee who prints and affixes label stated he does not review labels for content accuracy or assess if changes are made. We reviewed your firm’s responses and conclude that it is not adequate. Your firm provided the Dermo-Jet Labeling procedure (Doc. No DL0.001, Ver 001) and a draft Dermo-Jet label as part of your corrective actions. Your procedure instructs that the Dermo-Jet boxes are labeled correctly to ensure that the UDI, serial number, lot number, and manufacturer information is affixed on all shipping boxes. However, your procedure lacks detail concerning label integrity, inspection of labels, and storage requirements to control labeling activities. Also, your draft Dermo-Jet label does not contain UDI information but a QR Code without any additional information. In response to this letter, please provide updates and supporting documentation of your corrective actions as they are implemented.Observations Pertaining to Other RegulationsMedical Device Reporting ViolationOur inspection also revealed that your firm’s Dermo-Jet Needleless Injectors are misbranded under section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that your firm failed or refused to furnish material or information respecting the device that is required by or under section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR Part 803 - Medical Device Reporting. Significant violations include, but are not limited to, the following:Failure to develop, maintain, and implement written MDR procedures as required by 21 CFR 803.17. For example, during the inspection, your firm presented a two-page document titled “Summary of MDR Reporting Requirement for Manufacturers” as your written MDR procedure. However, upon review, it was determined that while the document references the 21 CFR 803.17 regulations, it does not provide information to demonstrate that it was developed as an MDR procedure in accordance with the requirements in 21 CFR 803.17.Additionally, your firm is recommended to establish an active Electronic Submissions Gateway (ESG) production account for the electronic submission of MDR reports. FDA verified that, as of October 20, 2024, your firm does not have such an account. Information about the ESG can be found at: How to Enroll in eMDR Program | FDA.The adequacy of your firm’s response dated June 21, 2024, cannot be determined at this time. The response notes that your firm plans to develop a procedure to address the requirements of 21 CFR 803.17. However, no procedure was attached to the response, as the corrective action is still in progress.We reviewed your firm’s response dated July 18, 2024, and conclude that it is not adequate. In the response, your firm includes a newly developed MDR procedure titled “MDR Reporting Requirements”, Document No. MDRR0.001, Version 001, dated July 9, 2024. After reviewing the procedure, the following deficiencies were noted:1.Your procedure does not establish 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.Your procedure omits definitions of the terms ‘become aware’, and ‘caused or contributed’, and the definition for the term ‘reasonably suggests’, found in 803.20(c)(1). The exclusion of the definitions for these terms from the procedure may lead your firm to make an incorrect reportability decision when evaluating a complaint that may meet the criteria for reporting under 21 CFR 803.50(a).b.Your procedure does not include instructions for how your firm will evaluate information about an event to make MDR reportability determinations in a timely manner.2.Your procedure does not establish internal systems that provide for a standardized review process to determine when an event meets the criteria for reporting under this part, as required by 21 CFR 803.17(a)(2). For example, your procedure does not specify who makes the decision for reporting events to FDA.3.Your procedure does not establish internal systems that provide for timely transmission of complete medical device reports, as required by 21 CFR 803.17(a)(3). Specifically, your procedure does not include instructions for how to obtain the FDA 3500A form.4.Your procedure does not describe how your firm will address documentation and record keeping requirements, as required by 21 CFR 803.17(b), including:a.Documentation of adverse event related information maintained as MDR event files.b.Documentation of the deliberations and decision-making processes used to determine if a device-related death, serious injury, or malfunction was or was not reportable, as required under 21 CFR 803.18(b)(1)(i).Additionally, your procedure includes a reference to submit MDRs to FDA via paper mail, and we recommend that all references to paper submissions be removed from your firm’s MDR procedure.Furthermore, your procedure includes a reference to submit a 10-workday report for reportable events involving death or serious injury. Please note that, under 21 CFR 803.10(c)(1), reports of death or serious injury must still be submitted within the 30-calendar days of the firm becoming aware of the event. We recommend your firm update the procedure to reflect the requirement.Your firm’s response dated August 15, 2024, did not provide any new information addressing the noted deficiencies.Misbranding under Section 502(t)(2) for Failure to Submit Required Information to GUDIDThe Dermo-Jet devices are misbranded within the meaning of section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that 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, respecting these devices. In particular, 21 CFR 801.20(a) requires, with exceptions not relevant here, that the label and device package of every medical device bear a unique device identifier (UDI) that meets the requirements of 21 CFR Part 801, subpart B, and 21 CFR Part 830. Also, 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 UDI.FDA has determined that your firm causes a label to be applied to Dermo-Jet devices with the intent that the devices will be commercially distributed without any subsequent replacement or modification of the label and/or causes the label of a device to be replaced or modified with the intent that the device will be commercially distributed without any subsequent replacement or modification of the label (except that the addition of the name of, and contact information for, a person who distributes the device, without making any other changes to the label, is not a modification for the purposes of determining whether a person is a labeler). Robbins Instruments LLC is therefore a “labeler” within the meaning of 21 CFR 830.3 and has not submitted to GUDID 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).Based on review of the Global Unique Device Identification Database (GUDID) on October 22, 2024, there are no entries for Robbins Instruments LLC or for devices with the trade names Dermo-Jet or any other injector associated with Robbins Instruments LLC. A search of GUDID was performed using the terms Robbins, Instruments, AKRA, Dermo-Jet, DJ05, injector, and KZE, and no relevant results were found. There are 32 entries in GUDID for the company name Robbins Instruments Inc, however none of the 32 entries is for the Dermo-Jet devices or any other injector.Your firm’s responses dated June 21, 2024, July 18, 2024, and August 15, 2024, are not adequate. Your firm’s response does not address GUDID reporting.Medical Device Registration and Listing ViolationUnder section 510 of the Act (21 U.S.C. § 360), manufacturers of medical devices are required to annually register with the FDA. In September 2007, section 510 of the Act was amended by the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-85) to require 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 1st and ending December 31st of each year. Our records indicate that your firm has not adequately fulfilled annual registration and listing requirements for fiscal year 2024.Therefore, all your firm’s devices are misbranded within the meaning of section 502(o) of the Act (21 U.S.C. § 352(0)), in that the devices 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)). For example, the violation includes:Your firm is registered as an initial distributor/importer for 2024, which does not align with your current type of operation. Our inspection revealed that your firm is engaged in manufacturing activities of your Dermo-Jet Needleless Injectors. Your firm is therefore required to annually register as a manufacturer and list the Dermo-Jet and other medical devices with the FDA.Your firm should take prompt action to address any violations identified in this letter. Failure to adequately address this matter may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties. Other federal agencies may take your compliance with the FD&C Act and its implementing regulations into account when considering the award of federal contracts. Additionally, should FDA determine that you have Quality System regulation violations that are reasonably related to premarket approval applications for Class III devices, such devices will not be approved until the violations have been addressed. Should FDA determine that your devices or facilities do not meet the requirements of the Act, requests for Certificates to Foreign Governments (CFG) may not be granted.Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to address the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (which must address systemic problems) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm’s response should be comprehensive and address any violations included in this Warning Letter. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration as part of your response.Your firm’s response should be sent via email to Establishment Assessment Team Assistant Director, Jessica Mu, at CDRHEnforcement@fda.hhs.gov. Please include in the subject line, the CMS Case #687984 when replying. If you have any questions about the contents of this letter, please contact: Compliance Officer, Charles J. Chacko at 214-253-4939, or via email at charles.chacko@fda.hhs.gov.Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of any violations and take prompt actions to address any violations and bring the products into compliance.Sincerely,/S/RDML Sean Boyd, MPH, USPHSDirectorOffice of Regulatory ProgramsOffice of Product Evaluation and QualityCenter for Device and Radiological Health