行政相对人名称 苏州金香玉医疗器械有限公司 行政相对人类别 法人及非法人组织 统一社会信用代码 913209130941280630 工商注册号 组织机构代码 税务登记号 事业单位证书号 社会组织登记证号 法定代表人 陈添阳 法定代表人证件类型 身份证 法定代表人证件号码 350************38 证件类型 证件号码 行政处罚决定书文号 苏药监苏处罚〔2025〕015号 违法行为类型 违反了《医疗器械生产监督管理办法》第十五条，依据《医疗器械监督管理条例》八十一条 违法事实 违反了《医疗器械生产监督管理办法》第十五条，依据《医疗器械监督管理条例》八十一条 处罚依据 违反了《医疗器械生产监督管理办法》第十五条，依据《医疗器械监督管理条例》八十一条 处罚类别 没收违法所得；罚款 处罚内容 没收违法所得1385元，并处6万元罚款，罚没款合计为61385元。 罚款金额（万元） 6.0 没收违法所得没收非法财物的金额（万元） 0.1385 暂扣或吊销证照名称及编号 处罚决定日期 2026/04/29 处罚有效期 2026/05/14 公示截止期 2029/04/29 处罚机关 江苏省药品监督管理局 处罚机关统一社会信用代码 11320000014000394R 数据来源单位 江苏省药品监督管理局 数据来源单位统一社会信用代码 11320000014000394R 备注 公示截止期依据文件：关于进一步规范“双公示”信息归集有关工作的通知

经核查，高亚丹等4人存在《执业药师注册证》挂靠行为。依据《执业药师职业资格制度规定》第二十八条和《执业药师注册管理办法》第三十四条规定，撤销高亚丹等4人的《执业药师注册证》，三年内不予注册，将不良信息记入全国执业药师注册管理信息系统。姓  名执业药师资格证书编号执业药师注册证编号注册单位高亚丹20201002652000000464521225020344盘州市德济药品销售有限公司杜明娇02620241052000003012521225230331晴隆县景兰药店曾红敏2017026520262015522809000086521223010449贵州一树药业股份有限公司一百五十一分店张艳20201002652000000351522224011445贵州宏福安堂药业有限公司特此公告。贵州省药品监督管理局2026年4月29日

　　根据《药品管理法》、《药品生产监督管理办法》有关规定，经现场检查并综合评定，现将厦门宝华生物制药有限公司《药品生产质量管理规范》符合性检查结果公告。企业名称检查地址检查范围检查时间类型检查结果厦门宝华生物制药有限公司（受托方：福建明华制药有限公司）。1.持有人检查地址（持有人注册地址）：厦门市海沧区新园路120号技术服务中心第8层03单元；2.对受托方（延伸检查）：福建省仙游县郊尾镇梅园街1893号。1.检查范围：叶酸片（规格5mg，国药准字H19983051；规格0.4mg，国药准字19993229），片剂；2.生产类型：委托生产；3.生产线：受托方固体制剂车间片剂生产线。1.持有人检查时间：2026年01月19日下午-01月21日上午；2.延伸检查时间：2026年02月03日下午02月-06日上午。依申请符合　　福建省药品监督管理局　　2026年4月28日

Delivery Method:Via Electronic Mail - Return Receipt RequestedReference #:320-26-70Product:Drugs;Over-the-Counter DrugsRecipient:Mr. Zhong MuqiChief Executive OfficerFoshan Miwei Cosmetics Co., Ltd.801 & 802, Building 9, Baofa Jewellry Industry CentreNo. 1 Feicui Road, Yang’e Village Committee, Lunjiao TownShunde QuFoshan ShiGuangdong Sheng,ChinaIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter320-26-70April 20, 2026Dear Mr. Muqi:The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Foshan Miwei Cosmetics Co., Ltd., FEI 3017118698, located at 801 & 802, Building 9, Baofa Jewellery Industry Centre, No. 1, Feicui Road, Yang’e Village Committee, Lunjiao Town, Shunde District, Foshan City, Guangdong Province, from October 20 to 24, 2025.This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 211).Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).In addition, Trust MD SPF 30 Stem Cell Face Cream and inBlair Elevate SPF 15 Moisturizer are unapproved new drugs introduced or delivered for introduction into interstate commerce in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a) and 331(d). Introduction or delivery for introduction of such products into interstate commerce is prohibited under sections 301(d) of the FD&C Act, 21 U.S.C. 331(d).Furthermore, Trust MD SPF 30 Stem Cell Face Cream and inBlair Elevate SPF 15 Moisturizer are misbranded under 502(a), 502(f)(1), and 502(ee) of the FD&C Act, 21 U.S.C. 352(a), (f)(1), and (ee). Introduction or delivery for introduction of such products into interstate commerce is prohibited under sections 301(a) of the FD&C Act, 21 U.S.C. 331(a). These violations are described in more detail below.We reviewed your November 7, 2025 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.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 over-the-counter (OTC)(b)(4)drug products. You did not test your drug products for the strength of each active ingredient prior to release and distribution. You also failed to conduct adequate microbiological testing for each batch of your OTC(b)(4)drug products. For example, your certificates of analysis (COAs) for(b)(4)batch(b)(4)and(b)(4)batch(b)(4)lacked active ingredient assay values and results for specified microorganisms.Full release testing, including for identity, strength, impurities, and microbiological limits, must be performed prior to drug product release and distribution.In response to this letter, provide:A list of chemical and microbial specifications, including test methods, used to analyze each batch of your drug products before a batch disposition decision.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.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.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.2. Your firm failed to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality. Your firm also failed to validate and establish the reliability of your component supplier’s test analyses at appropriate intervals. Your firm also failed to conduct microbiological testing before use of each lot of a component with potential for objectionable microbiological contamination in light of its intended use (21 CFR 211.84(d)(1) and 211.84(d)(2)) and (21 CFR 211.84(d)(6)).Active Ingredients and Components at Risk for(b)(4)ContaminationYou failed to perform adequate identity testing of each component lot used in the manufacture of your drug products including your active pharmaceutical ingredients, such as(b)(4). Additionally, your firm failed to perform adequate identity testing of each shipment of each lot of incoming components at high risk of(b)(4)contamination. For example, your firm’s in-house raw material report for(b)(4)lot(b)(4), used to manufacture(b)(4)batch number(b)(4), lacked data for identity,(b)(4)limits. Furthermore, you relied on your suppliers’ COAs without establishing the reliability of each of your component supplier’s test analysis at appropriate intervals.Identity testing for(b)(4)and certain other high-risk drug components includes a limit test in the United States Pharmacopeia (USP) to ensure that the component meets the relevant safety limits for levels of(b)(4). Because you did not perform identity testing on each shipment of each lot using the USP identification test that detects these hazardous impurities, you failed to ensure the acceptability of this component for use in the manufacture of your drug products.The use of ingredients contaminated with(b)(4)has resulted in various lethal poisoning incidents in humans worldwide. See FDA’s guidance document(b)(4)(b)(4)Used as a Component in Drug ProductsYour firm failed to adequately monitor(b)(4)and the microbiological quality of(b)(4)used as a component in drug product manufacturing.(b)(4)must be suitable for its intended use and routinely tested to ensure ongoing conformance with appropriate chemical and microbiological attributes.In your response, you state that you will establish raw material specifications, testing of all incoming materials, a supplier qualification procedure, and a microbial control program for your(b)(4)system.Your response is inadequate because it lacks sufficient details on the remediation of your incoming materials testing program. It also does not include a retrospective review, analysis, and risk assessment for distributed drug products within expiry.In response to this letter, provide:A commitment to provide(b)(4)test results, no later than 30 calendar days from the date of this letter, from testing retains for all lots of high-risk drug components used in the manufacture of drug products. Alternatively, if a retain of a component lot is unavailable, perform retain sample testing of all implicated finished drug product batches for the presence of(b)(4).A full risk assessment for drug products that are within expiry which contain any ingredient at risk for(b)(4)contamination (including, but not limited to,(b)(4)). Take prompt and appropriate actions to determine the safety of all lots of the component(s) and any related drug product that could contain(b)(4), including customer notifications and product recalls for any contaminated lots. Identify additional appropriate corrective actions and preventive actions (CAPA) that secure supply chains in the future, including, but not limited to, ensuring that all incoming raw material lots are from fully qualified manufacturers and free from unsafe impurities. Detail these actions in your response to this letter.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(b)(4), and certain additional high-risk components we note that this includes the performance of(b)(4).A comprehensive, independent review of your material system, including but not limited to:o evaluating all suppliers of materials (components, containers, and closures) to determine if they are reliable and appropriately qualifiedo an assessment of all materials to determine whether they are consistently of acceptable qualityo a review to ensure assigned expiration or retest dates are appropriate (supported by data)o adequacy of the supplier qualification program, and its selection, qualification, and disqualification provisionsBased on a thorough review, provide a summary of your systems CAPA to remediate the vendor qualification program and prevent use of unsuitable components, containers and closuresThe chemical and microbiological quality control specifications you use to test and release each incoming lot of component for use in manufacturing.A summary of results obtained from testing all components to evaluate the reliability of the COA from each component manufacturer. Include your SOP that describes this COA validation program.A summary of your program for qualifying and overseeing contract facilities that test the drug products you manufacture.A procedure governing your program for ongoing control and monitoring that ensures your(b)(4)system consistently produces(b)(4)that meets(b)(4), USP monograph specifications and appropriate microbial limits.3. Your firm failed to establish and follow a written testing program designed to assess the stability characteristics of drug products and to use results of stability testing to determine appropriate storage conditions and expiration dates (21 CFR 211.166(a)).Your firm failed to establish an adequate stability program with data demonstrating that the drug products remain acceptable throughout the labeled expiry date. For example, you assigned(b)(4)expiration dates to(b)(4)batch(b)(4),(b)(4)batch(b)(4), and(b)(4)batch(b)(4)without initiating stability testing.Without appropriate stability studies, you lack sufficient scientific evidence to support that your drug products retain their quality attributes throughout the labeled expiry period or determine appropriate storage conditions for your drug products.In your response, you state that you will begin stability studies. Your response is inadequate because it lacks sufficient detail describing your stability program procedures and protocols, or equipment for these studies.In response to this letter, provide:A comprehensive assessment and CAPA plan to ensure the adequacy of your stability program. Your remediated program should include, but not be limited to:o Stability-indicating methodso Stability studies for each drug product in its marketed container-closure system before distribution is permittedo An ongoing program in which representative batches of each product are added each year to the program to determine if the shelf-life claim remains valido Detailed definition of the specific attributes to be tested at each station (timepoint)o All procedures that describe these and other elements of your remediated stability program.4. Your firm failed to establish written responsibilities and procedures applicable to the quality control unit and to follow such written procedures (21 CFR 211.22(d)).You lacked an adequate quality unit (QU) to provide oversight for the manufacture of your drug products. For example, you did not review, approve, or implement procedures for critical quality operations such as handling non-conformances, change control, training management, and handling out-of-specification events.In your response, you commit to establishing and implementing quality oversight procedures.Your response is inadequate. Although you commit to addressing the observations, your response lacks sufficient details about the systemic remediations needed for your QU and your quality system.In response to this letter, provide:A comprehensive assessment and remediation plan to ensure your QU is given the authority and resources to effectively function. The assessment should also include, but not be limited to:o A determination of whether procedures used by your firm are robust and appropriateo Provisions for QU oversight throughout your operations to evaluate adherence to appropriate practiceso A complete and final review of each batch and its related information before the QU disposition decisiono Oversight and approval of investigations and discharging of all other QU duties to ensure identity, strength, quality, and purity of all productsCGMP 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 audit1of 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.Unapproved New Drugs and Misbranded Drug ViolationsTrust MD SPF 30 Stem Cell Face Cream and inBlair Elevate SPF 15 Moisturizer products 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 product labeling provide evidence of intended uses (as defined in 21 CFR 201.128) of these products include, but may not be limited to, the following:Trust MD SPF 30 Stem Cell Face Cream“SPF 30…Drug Facts…Uses…Helps prevent sunburn…PLANT-BASED STEM CELLS: Improves texture, fine lines, and skin tone by restoring cells natural balance pH. Promotes collagen production…SODIUM HYALURONATE:…It repairs and protects youthful skin cells...Vitamins B5, C, …B5 binds moisture to skin cells, which plumps and firms the skin, and erases fine lines…C…promotes collagen production…” [from product label]inBlair Elevate SPF 15 Moisturizer“SPF 15…Drug Facts… Use… Helps prevent sunburn…To aide in the protection against harmful UV rays…VITAMIN B3 can reduce hyperpigmentation, & inflammation” [from product label]Unapproved New Drug ViolationsBased on the above labeling evidence, your Trust MD SPF 30 Stem Cell Face Cream and inBlair Elevate SPF 15 Moisturizer are drug products intended for use as over-the-counter (OTC) sunscreen drug products. As described below, these OTC drug 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).In general, a drug product is a “new drug” within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p), if it is not generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended, or suggested in its labeling. With 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 section 505(a) of the FD&C Act, 21 U.S.C. 355(a), unless it is lawfully marketed under section 505G of the FD&C Act, 21 U.S.C 355h. No FDA-approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for any of the drug products identified above.Under section 505G of the FD&C Act, certain nonprescription drugs marketed without an approved application —commonly referred to as "OTC monograph drugs"—may be legally marketed if they meet applicable requirements. With respect to nonprescription (OTC) sunscreen drug products, in order to be GRASE and not new drugs, the product must, among other things, conform to the conditions of use set forth in the applicable OTC monograph(s). Nonprescription (OTC) sunscreen drug products are addressed in the “Sunscreen Drug Products for Over-the-Counter Human Use” (M020)2.However, Trust MD SPF 30 Stem Cell Face Cream and inBlair Elevate SPF 15 Moisturizer sunscreen products described above do not comply with conditions specified in M020 for the reasons below.As labeled, "Trust MD SPF 30 Stem Cell Face Cream" includes the active ingredients Plant-Based Stem Cells, Sodium Hyaluronate, and Vitamins B and C that are not permitted active ingredients under M020.10. CFR 201.66(b)(2) defines “active ingredient” to mean “any component that is 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 any function of the body of humans.” Although the product label does not specifically list Plant-Based Stem Cells, Sodium Hyaluronate, and Vitamins B and C as active ingredients in the Drug Facts, the product labeling makes claims such as “PLANT-BASED STEM CELLS: Improves texture, fine lines, and skin tone by restoring cells natural balance pH. Promotes collagen production…SODIUM HYALURONATE:…It repairs and protects youthful skin cells...Vitamins B5, C, …B5 binds moisture to skin cells, which plumps and firms the skin, and erases fine lines…C…promotes collagen production…” which demonstrate that these are “active ingredients” in your sunscreen products because they are intended to furnish pharmacological activity.In addition, as labeled, "inBlair Elevate SPF 15 Moisturizer" includes the active ingredient VITAMIN B3 that is not a permitted active ingredient under M020.10. Although the product label does not specifically list VITAMIN B3 as an active ingredient in the Drug Facts panel for “inBlair Elevate SPF 15 Moisturizer,” label claims such as “VITAMIN B3 can reduce hyperpigmentation, & inflammation” demonstrate that this is an “active ingredient” in your sunscreen product because it is intended to furnish pharmacological activity.Thus, your Trust MD SPF 30 Stem Cell Face Cream and inBlair Elevate SPF 15 Moisturizer sunscreen products identified above do not comply with the conditions set forth in M020 and have not otherwise been found GRASE.3Accordingly, these products are new drugs within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p), and there is no basis under section 505G of the FD&C Act in which these products would be legally marketed without an approved application. Because there are no applications in effect for these products, the Trust MD SPF 30 Stem Cell Face Cream and inBlair Elevate SPF 15 Moisturizer sunscreen products are unapproved new drugs.The introduction or delivery for introduction of unapproved new drug products into interstate commerce violates sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d).Misbranded Drug ViolationsTrust MD SPF 30 Stem Cell Face Cream and inBlair Elevate SPF 15 Moisturizer are misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a), because the labeling for these products are false or misleading for several reasons. First, the labeling for Trust MD SPF 30 Stem Cell Face Cream identifies Plant-Based Stem Cells, Sodium Hyaluronate, Vitamins B, and C as inactive ingredients but represents these ingredients as having purported active pharmacological properties. Similarly, labeling for inBlair Elevate SPF 15 Moisturizer identifies Vitamin B3 as an inactive ingredient but represents this ingredient as having purported active pharmacological properties. Even if Plant-Based Stem Cells, Sodium Hyaluronate, Vitamins B, C, and B3 could be considered inactive ingredients in these products, the prominent featuring of these substances on the product labeling causes these products to be misbranded under section 502(a) of the FD&C Act, which deems a drug to be misbranded if its labeling is “false or misleading in any particular,” and under 21 CFR 201.10(c)(4).4Under 21 CFR 201.10(c)(4), “[t]he labeling of a drug may be misleading by reason . . . [of] the featuring in the labeling of inert or inactive ingredients in a manner that creates an impression of value greater than their true functional role in the formulation.”Furthermore, your Trust MD SPF 30 Stem Cell Face Cream and inBlair Elevate SPF 15 Moisturizer sunscreen products are further misbranded under section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1), because their labeling does not bear adequate directions for use. Here, the directions set forth in M020.50(e) are required for a sunscreen drug product to be legally marketed under section 505G of the FD&C Act. This monograph labeling also falls within the scope of the directions described in section 502(f)(1) of the FD&C Act. Your Trust MD SPF 30 Stem Cell Face Cream and inBlair Elevate SPF 15 Moisturizer fails to include “[bullet] apply [select one of the following: `Liberally' or `generously'] [and, as an option: `And evenly'] 15 minutes before sun exposure" and “[bullet] children under 6 months of age: Ask a doctor" as required under M020.50(e)(1)(ii) and (iv) and fails to include "[bullet] reapply at least every 2 hours [bullet] use a water resistant sunscreen if swimming or sweating" as required under M020.50(e)(4). The omission of these monograph directions from your products’ labeling renders them misbranded under section 502(f)(1).In addition, Trust MD SPF 30 Stem Cell Face Cream and inBlair Elevate SPF 15 Moisturizer are also misbranded under section 502(ee) because as nonprescription drugs subject to section 505G of the FD&C Act, 21 U.S.C. 355h, these products do not comply with the requirements for marketing under that section and are not the subject of an application approved under section 505 of the FD&C Act, 21 U.S.C. 355.The introduction or delivery for introduction of a misbranded drug into interstate commerce violates section 301(a) of the FD&C Act, 21 U.S.C. 331(a).ConclusionThe violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations.FDA placed all drugs and drug products offered for import into the United States from your firm on Import Alert 66-40 on February 13, 2026.Correct any violations promptly. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to any violations.Failure to address any violations may also result in the FDA continuing to refuse admission of articles manufactured at Foshan Miwei Cosmetics Co., Ltd., 801 & 802, Building 9, Baofa Jewellery Industry Centre, No. 1, Feicui Road, Yang’e Village Committee, Lunjiao Town, Shunde District, Foshan City, 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 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 3017118698 and ATTN: Marisa Heayn.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and Research/S/Tina SmithCaptain, U.S. Public Health ServiceDirectorOffice of Unapproved Drugs & Labeling ComplianceOffice of ComplianceCenter for Drug Evaluation and Research___________________________1i.e. Quality System, Facilities & Equipment System, Materials System, Production System, Packaging & Labeling System, and Laboratory Control System per FDA’s guidance document.2M020, in the final administrative order, Over-the-Counter Monograph M020: Sunscreen Drug Products for OTC Human Use, reflects the conditions in the relevant final order established and in effect under section 505G. See Order ID OTC000034, available at FDA’s website OTC Monographs@FDA, https://www.accessdata.fda.gov/scripts/cder/omuf/.3FDA is not aware of any adequate and well-controlled clinical trials in the published literature that support a determination that "Trust MD SPF 30 Stem Cell Face Cream" and "inBlair Elevate SPF 15 Moisturizer" products are GRASE for use under the conditions prescribed, recommended, or suggested in their labeling, nor has FDA determined these drug products to be GRASE pursuant to an order issued under section 505G(b).4Additionally, Trust MD SPF 30 Stem Cell Face Cream also prominently features vitamin E on the labeling and inBlair Elevate SPF 15 Moisturizer also prominently features collagen peptides on the labeling that creates an impression of value greater than its functional role in the formulation that further causes these products to be misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a).

根据《中华人民共和国药品管理法》《药品生产监督管理办法》《药品检查管理办法（试行）》《药品生产质量管理规范符合性检查工作程序》有关规定及要求，我局对西安兆兴制药有限公司等4家药品生产企业进行药品生产质量管理规范符合性检查和审核，经现场检查并综合评定，现将检查结果通告如下：企业名称检查地址检查范围及相关车间、生产线检查时间检查结论西安兆兴制药有限公司陕西省西咸新区秦汉新城窑店街道办光伏一路1号海璟城秦汉创业中心23幢1-4层口服溶液剂（液体制剂车间，口服溶液剂生产线）2026年1月21日-2026年1月23日符合陕西大生制药科技有限公司西安沣京工业园振兴路8号原料药：盐酸尼卡地平（102车间，盐酸尼卡地平生产线）2026年1月19日-2026年1月23日符合陕西顿斯制药有限公司西安沣京工业园标准化厂房一期建设区注射用头孢拉定（规格：0.5g)(头孢粉针剂201车间，头孢粉针剂生产线）2026年1月5日至2026年1月9日符合杨凌吉泰药业有限公司陕西省杨凌示范区兴杨路2号片剂（固体制剂车间，片剂生产线）2026年3月10日-2026年3月13日符合陕西省药品监督管理局2026年4月22日（公开属性：主动公开）

根据《中华人民共和国药品管理法》《药品生产监督管理办法》《药品检查管理办法（试行）》《药品生产质量管理规范符合性检查工作程序》等有关规定及要求，我局对周至年青保制药有限公司等4家药品生产企业进行药品GMP符合性检查和审核，经现场检查并综合评定，现将检查结果通告如下：企业名称检查地址检查范围及相关车间、生产线检查时间检查结论周至年青保制药有限公司陕西省西安市周至县108国道1420马召段胶囊剂，酊剂（制剂车间胶囊剂酊剂生产线）2026年1月5日-2026年1月9日符合要求委托方：靖鸿屹立（陕西）药业有限公司受托方：西安天一秦昆制药有限责任公司西安天一秦昆制药有限责任公司：陕西省铜川市新区大唐三路1号委托品种：补脾消积口服液（口服液体车间合剂生产线）复方锌布颗粒（口服固体车间颗粒剂生产线）2026年2月3日-2026年2月6日符合要求委托方：陕西医药控股集团山海丹药业股份有限公司受托方：西安恒生堂制药有限公司陕西孙思邈高新制药有限公司西安恒生堂制药有限公司：陕西省西安市高陵区泾渭南路629号陕西孙思邈高新制药有限公司：陕西省咸阳市秦都区平安路8号委托品种：山海丹胶囊（前处理和提取车间、制剂车间胶囊剂生产线）止嗽合剂（前处理车间，提取车间，综合制剂车间液体制剂生产线）2026年1月20日-2026年1月23日                2026年1月27日-2026年1月30日符合要求陕西天地人和药业有限公司陕西省渭南市高新技术产业开发区建业路1号原料药(左奥硝唑、磷酸左奥硝唑酯二钠)（原料药车间（5车间）原料药生产线）2026年3月17日-2026年3月25日符合要求陕西省药品监督管理局2026年4月24日（公开属性：主动公开）

Delivery Method:VIA EMAIL WITH READ RECEIPTProduct:Drugs;Over-the-Counter DrugsRecipient:Mrs. Lois F. ElliottCo-OwnerLexia LLC367 Riverside Drive, Suite 100Franklin,TN37064-8977United StatesIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter320-26-59April 7, 2026Dear Mrs. Elliott:The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Lexia LLC, FEI 3011863647, at 367 Riverside Drive, Suite 1003, Franklin, TN, from September 23 to 29, 2025.This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 211).Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).We have not received a response from your firm stating the actions you are taking to address the deficiencies identified during the inspection and cited on our Form FDA 483. During the inspection, your firm notified the Agency that you do not intend to manufacture drug products and have discontinued your FDA drug registration. We received your correspondence dated November 26, 2025, accepting the observations made during the inspection and reiterating your decision to discontinue production of drug products.During 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. Your firm also failed to conduct appropriate laboratory testing, as necessary, for each batch of drug product required to be free of objectionable microorganisms (21 CFR 211.165(a) and 211.165(b)).Your firm failed to conduct adequate finished product release testing for each batch of your drug products including, but not limited to, testing the identity and strength of the active ingredient,(b)(4), and testing for objectionable microorganisms.For example, your firm manufactures(b)(4), an over-the-counter (OTC) topical pain relief drug product. The only tests you perform on the finished product are for viscosity, pH, and color. Your firm stated your OTC drug product lacks a final product specification and does not follow recognized standards.Appropriate testing is an essential part of ensuring that the drug products you manufacture conform to CGMP. Without adequate finished product release testing, you do not have scientific evidence that each batch of drug product conforms to predetermined 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 lot 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.A comprehensive 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.2. Your firm failed to conduct at least one test to verify the identity of each component of a drug product. Your firm also failed to validate and establish the reliability of your component supplier’s test analyses at appropriate intervals (21 CFR 211.84(d)(1) and 211.84(d)(2)).Your firm failed to test incoming components used in manufacturing your finished OTC drug products to determine identity, purity, strength, and quality. Additionally, your firm did not establish a vendor qualification program for your raw material suppliers.Your firm used results from your suppliers’ certificates of analysis (COAs) without establishing the reliability of your suppliers’ analyses through appropriate validation and without conducting at least one specific identity test on each incoming lot of components. You cannot rely on your suppliers’ COAs to verify the identity of your components.In addition, your firm uses(b)(4)as a component in the manufacture of your OTC topical pain relief drug product. During the inspection, you stated that you do not test your(b)(4)system for objectionable microorganisms, total organic carbon, conductivity, or pH. Your firm has not demonstrated that the(b)(4)is suitable for its intended use for pharmaceutical manufacturing and meets the(b)(4)USP monograph for chemical and microbiological attributes.The lack of data regarding the state of control of your(b)(4)system poses a potential risk for objectionable microbiological contamination into your drug products.(b)(4)must be suitable for its intended use and routinely tested to ensure ongoing conformance with appropriate chemical and microbiological attributes. All components, including(b)(4), must be tested prior to use as required by 21 CFR 211.84(a).(b)(4)Your firm’s OTC topical pain relief drug product uses(b)(4)Without adequate testing and confirmation of reliability of supplier and external laboratory testing results, you lack scientific evidence that your components or drug products conform to appropriate specifications.In response to this letter, please provide:A comprehensive, independent review of your material system including, but not limited to:o evaluating all suppliers of materials (components, containers, and closures) to determine if they are reliable and appropriately qualifiedo an assessment of all materials to determine whether they are consistently of acceptable qualityo a review to ensure assigned expiration or retest dates are appropriate (supported by data)o adequacy of the supplier qualification program and its selection, qualification, and disqualification provisions.Based on a thorough review, provide a summary of your systems CAPA to remediate the vendor qualification program and prevent use of unsuitable components, containers and closures.The chemical and microbiological quality control specifications you use to test and release each incoming lot of component for use in manufacturing.A description of how you will test each component lot for conformity with all appropriate specifications for identity, strength, quality, and purity. If you intend to accept any results from your supplier’s COAs instead of testing each component lot for strength, quality, and purity, specify how you will robustly establish the reliability of your supplier’s results through initial validation as well as periodic re-validation. In addition, include a commitment to always conduct at least one specific identity test for each incoming component lot.A commitment to provide(b)(4)test results, no later than 30 calendar days from the date of this letter, from testing retains for all lots of high-risk drug components used in the manufacture of drug products. Alternatively, if a retain of a component lot is unavailable, perform retain sample testing of all implicated finished drug product batches for the presence of(b)(4).3. Your firm failed to assure that the drug product bore an expiration date that was supported by appropriate stability testing (21 CFR 211.137(a)).Your firm assigned a(b)(4)expiry period to your OTC topical pain relief product without scientific rationale to support the labeled expiry. At the time of inspection, you lacked stability data to support the(b)(4)expiry period. There was no assurance that your drug product will remain acceptable throughout its labeled expiry period without an established stability program. During the inspection, you stated that your product’s expiry is “anecdotal.”For products without appropriate stability studies, there is insufficient scientific evidence to support that the drug products will meet established specifications and retain their quality attributes through their assigned expiry.In response to this letter, provide:A comprehensive assessment and CAPA plan to ensure the adequacy of your stability program. Your remediated program should include, but not be limited to:o Stability indicating methodso Stability studies for each drug product in its marketed container-closure system before distribution is permittedo an ongoing program in which representative batches of each product are added each year to the program to determine if the shelf-life claim remains valido detailed definition of the specific attributes to be tested at each station (timepoint)o all procedures that describe these and other elements of your remediated stability program.4. Your firm failed to establish adequate written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(a)).You lacked process validation data to demonstrate that the manufacturing process used to manufacture your OTC topical pain relief product is reproducible and controlled to consistently yield drugs of uniform character and quality.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 the FDA considers appropriate elements of process validation at https://www.fda.gov/media/71021/download.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.5. Your firm failed to establish an adequate quality unit and the responsibilities and procedures applicable to the quality control unit are not in writing and fully followed (21 CFR 211.22(a) and (d).You lacked a quality unit (QU) with appropriate oversight for the manufacture of your drug products, and you did not have written quality procedures. Your firm has one SOP that does not adequately govern quality processes for CGMP. For example, you failed to ensure the following:Investigation of any unexplained discrepancy or failure of a batch or any of its components to meet any specifications (21 CFR 211.192).Written records describing the evaluation of quality standards of each drug product at least annually to determine the need for changes in drug product specifications, manufacturing, or control procedures (21 CFR 211.180(e)).Failure to retain and store, under conditions consistent with product labeling, an appropriately identified reserve sample that is representative of each batch of drug product (21 CFR 211.170(b).Establishment of written procedures describing the handling of all written and oral complaints regarding a drug product (21 CFR 211.198(a)).Establishment of a system by which the distribution of each lot of drug product can be readily determined to facilitate its recall if necessary (21 CFR 211.150(b)).Establishment of adequate batch production and control records that contain the accomplishment of each significant step in the manufacture, processing, packing, or holding of the batch, for each batch of drug product (21 CFR 211.188(b)).Establishment of an appropriate program for cleaning and maintenance of equipment (21 CFR 211.67(b)).Operators received adequate CGMP training for the production of OTC drug products (21 CFR 211.25(a)).Your firm’s quality systems are inadequate. See FDA’s guidance documentQuality Systems Approach to Pharmaceutical CGMP Regulationsfor help in implementing quality systems and risk management approaches to meet the requirements of CGMP regulations 21 CFR parts 210 and 211, at https://www.fda.gov/media/71023/download.In response to this letter, provide:A 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 appropriateo Provisions for QU oversight throughout your operations to evaluate adherence to appropriate practiceso A complete and final review of each batch and its related information before the QU disposition decisiono Oversight and approval of investigations and discharging of all other QU duties to ensure identity, strength, quality, and purity of all productsDrug Production CeasedWe acknowledge your commitment to cease production of all OTC drugs at this facility and that you deregistered your facility as a drug manufacturer.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 action and preventive action (CAPA).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.Cosmetics Manufactured for Distribution in the United StatesIn addition, 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. We note that 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.We also note that the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) provides new requirements with which facilities that manufacture cosmetic products must comply. You may find the FD&C Act, MoCRA, and FDA’s regulations through links on FDA’s website at www.fda.gov.ConclusionThe violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations.Correct any violations promptly. Failure to promptly and adequately address this matter may result in regulatory or legal action without further notice including, without limitation, seizure and injunction. Unresolved violations may also prevent other Federal agencies from awarding contracts.Failure to address violations may also cause FDA to withhold issuance of Export Certificates. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to address any violations.This letter notifies you of our findings and provides you an opportunity to address the above deficiencies. After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any violations and to prevent their recurrence. In response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion.Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 3011863647 and ATTN: Maria Pavco.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and Research

Delivery Method:VIA EMAIL WITH READ RECEIPTReference #:320-26-57Product:DrugsRecipient:Mr. Kirti MaheshwariChief Operating OfficerIntas Pharmaceuticals LimitedPlot No. 255, Magnet Corporate ParkNr. Sola Bridge, S. G. Highway, ThaltejAhmedabadIndiaIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter320-26-57March 30, 2026Dear Mr. Maheshwari:The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Intas Pharmaceuticals Limited, FEI 3005890633, located at Camp Road, Selaqui, Dehradun, from September 8 to 17, 2025.This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 211).Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).We reviewed your October 8, 2025, response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence.During our inspection, our investigators observed specific violations including, but not limited to, the following.1. Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192).Your investigations into out-of-specification (OOS) assay results were inadequate. Your corrective and preventive actions (CAPAs) to address your persistent OOS assay results for(b)(4)tablets were not robust, as evidenced by the continued trend of subpotent assay stability failures and multiple(b)(4)to drug product expiry period.For example, since 2023, your testing has shown multiple confirmed stability OOS results for(b)(4)batches. You(b)(4)your expiry period from(b)(4)to(b)(4), and then further(b)(4)it to the current(b)(4). We acknowledge your decision to recall(b)(4)batches of(b)(4)tablets in response to stability OOS results since 2024.Multiple CAPAs included changes to batch processing to prevent further degradation of the active pharmaceutical ingredient. You also implemented modifications to your assay sample preparation procedures. However, you still experienced OOS assay results. For example, you tested 12-month long term stability batch(b)(4)and had a confirmed OOS result of(b)(4)% (specification is(b)(4)%). Your investigation of this 12-month stability failure was inadequate.You identified the root cause as “product behavior” and recalled this batch. You did not adequately evaluate the reserves of all distributed batches or reserve batches using the same API lot to determine if market action is warranted, as required.After the initial OOS result, you proceeded to test samples from the same batch and other previously OOS batches, using a revised analytical method with a different sample preparation and obtained different results. Despite using the revised analytical method, two batches ((b)(4)and(b)(4),(b)(4)tablets USP(b)(4)mcg and(b)(4)mcg) remained out of specification. Your investigation failed to evaluate why these batches still failed or assess whether the analytical method itself contributes to result variability. Attributing a failure to inherent drug product behaviors is not scientifically sound when a change in the test method yields a different outcome.Additionally, after you implemented your revised method in July 2025 you continued to experience low assay results. For example, you invalidated an assay result of(b)(4)% for a sample batch ((b)(4)) used as a control due to “solution preparation error” without conclusive supporting evidence, despite the sample preparation analysis being deemed “satisfactory” during the laboratory Phase I investigation. You did not issue a CAPA plan for analyst training. You also discarded the initial OOS with insufficient supporting documentation and did not include it in your final reporting of the assay result.In your response, you attribute the low assay values to the analytical limitation in the assay method, specifically incomplete extraction of the active pharmaceutical ingredient. You state it is not “totally due to actual product degradation.” You discuss your submission of a(b)(4)to the Agency to address the assay OOS results. Using the revised method, your new assay results appeared to be closer to the lower specification end. The variability in the new results does not clearly explain why these results are outside of the target assay value.Additionally, you initiated testing of all(b)(4)distributed batches of(b)(4)tablets USP (all strengths) within their approved shelf-life for the U.S. market. All batches met the specification criteria.Your response is inadequate. Your response does not address why the extraction limitation was not identified during the original method validation or explain what failures in your method validation process allowed this critical deficiency. In addition, your impact assessment of the evaluation of the extraction method did not extend to all assay values specifically which were on the higher end of the specification. Your response does not review or correlate market complaints or adverse events with low assay batches, which would be critical for a patient safety assessment.In response to this letter, provide the following:An impact assessment of(b)(4)tablet batches within expiry that showed assay results below your target assay. This assessment can coincide with your protocol for impact assessment for batches in the U.S. market that have stability testing assay results below(b)(4)%. Identify any common variables leading to the low assay values. Provide the OOS investigations for batch(b)(4)and all OOS assay failures for(b)(4)tablets since the FDA inspection.An assessment of each drug product process to ensure that there is a data-driven and scientifically sound program that identifies and controls all sources of variability, such that your production processes, and will consistently meet appropriate specifications and manufacturing standards. This includes, but is not limited to, evaluating suitability of equipment for its intended use, sufficiency of detectability in your monitoring and testing systems, quality of input materials, and reliability of each manufacturing process step and control.A comprehensive, independent assessment of your overall system for investigating deviations, discrepancies, complaints, OOS results, and failures. Provide a detailed action plan to remediate this system. Your action plan should include, but not be limited to, significant improvements in investigation competencies, scope determination, root cause evaluation, CAPA effectiveness, quality assurance oversight, and written procedures. Address how your firm will ensure all phases of investigations are appropriately conducted.An independent third-party assessment and remediation plan for your CAPA program. Provide a report that evaluates whether the program includes effective root cause analysis, ensures CAPA effectiveness, analyzes investigations trends, improves the CAPA program when needed, implements final quality assurance decisions, and is fully supported by executive management.2. Your firm’s quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22).Your firm lacks controls to assure the integrity of electronic batch record data. Your quality assurance employee instructed your software vendor to make changes to your electronic batch record which were not captured in the audit trail or managed through your quality system.During the inspection, you provided written communication from a quality assurance employee to the software vendor that discussed multiple changes and modifications made to the electronic batch record. One of the changes included the replacement of an employee identification number with another employee number for “Dispensed by” in(b)(4)tablets USP(b)(4)mcg batch record(b)(4). The change was not recorded in the audit trail, nor was it noted in the electronic batch record. Additionally, your firm lacked detailed procedural controls to assure the integrity of electronic batch record data when modifications are made after completion of the batch record.In your response, you indicate that the changes the software vendor made in the electronic batch record corrected inaccuracies only. You state your requests to software vendors to modify data have been terminated. You commit to conducting formal interviews with employees who contacted the vendors to request the data changes and to initiating deviation investigations. You commit to performing a retrospective review of all group and individual email messages sent to the software vendor to determine which email messages contained CGMP instructions. You also commit to conducting a review of the audit trails of all U.S. batches.Your response is inadequate. You fail to provide documentation of the deviations, interview transcripts, or discussion held with the employees who requested changes to electronic batch record data. You fail to explain why Quality Assurance did not initiate a deviation upon finding discrepancies or why the batch record contained no comments or remarks about the employee identification change. Additionally, your retrospective review of email requests to software vendors for data changes did not include an assessment of communications with other software vendors such as(b)(4).In response to this letter, provide the following:A retrospective review of all software related communications and correlated audit trail between your Intas Dehradun facility and software support vendors. Provide any updated deviations and related CAPA reports.A product impact assessment for identified communications related to changes in batch record data and process parameters.Effectiveness checks for the CAPAs implemented in your “Data Integrity Risk Assessment” of software applications, conducted by third party consultants in 2024.Performance qualification deviations for your(b)(4)filling machine ((b)(4), Model(b)(4), equipment ID: DP-38). Include a report discussing the discrepancies in entries in the data sheet versus audit trail data, including maximum(b)(4). This equipment is related to a(b)(4)for(b)(4)solution(b)(4).A comprehensive assessment and remediation plan to ensure your quality unit (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 appropriateo Provisions for QU oversight throughout your operations to evaluate adherence to appropriate practiceso A complete and final review of each batch and its related information before the QU disposition decisiono Oversight and approval of investigations and discharging of all other QU duties to ensure identity, strength, quality, and purity of all productso Also describe how top management supports quality assurance and reliable operations, including but not limited to timely provision of resources to proactively address emerging manufacturing/quality issues and to assure a continuing state of control.ConclusionThe violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations.If you are considering an action that is likely to lead to a disruption in the supply of drugs produced at your facility, FDA requests that you contact CDER’s Drug Shortages Staff immediately, at drugshortages@fda.hhs.gov, so that FDA can work with you on the most effective way to bring your operations into compliance with the law. Contacting the Drug Shortages Staff also allows you to meet any obligations you may have to report discontinuances or interruptions in your drug manufacture under 21 U.S.C. 356C(b). This also allows FDA to consider, as soon as possible, what actions, if any, may be needed to avoid shortages and protect the health of patients who depend on your products.Correct any violations promptly. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to any violations.Failure to address any violations may also result in the FDA refusing admission of articles manufactured at Intas Pharmaceuticals Limited located at Camp Road, Selaqui, Dehradun, 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 days1. 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 3005890633 and ATTN: Erika V. Butler.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and Research________________1Under program enhancements for the Generic Drug User Fee Amendments (GDUFA) reauthorization for fiscal years (FYs) 2023-2027, also known as the GDUFA III Commitment Letter, your facility may be eligible for a Post-Warning Letter Meeting to obtain preliminary feedback from FDA on the adequacy and completeness of your corrective action plans.