行政相对人名称四川省迪威药业有限责任公司行政相对人类别法人组织行政相对人代码91511025206761366A法定代表人赵林行政处罚决定书文号川药监罚决〔2025〕3103号违法行为类型生产销售劣药违法事实生产销售重量差异不符合标准规定的复方丹参片241001批次66600瓶、250201批次67200瓶，货值金额462120.60元，违法所得457350.60元。处罚依据《药品管理法》第一百一十七条第一款处罚类别没收非法财物、没收违法所得、罚款处罚内容1.没收违法生产的241001批次、250201批次复方丹参片1279瓶；2.没收违法所得457350.60元；3.并处罚款462120.60元。没收违法所得、没收非法财物的金额（万元）45.74处罚决定日期2025年12月24日处罚机关四川省药品监督管理局处罚机关统一社会信用代码11510000MB1808933T

行政相对人名称四川省天府神龙中药饮片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(统一社会信用代码)91510623597503873R法定代表人黎伯祥行政处罚决定书文号川药监罚决〔2025〕2013号违法行为类型《中华人民共和国药品管理法》第九十八条违法事实当事人生产销售的中药饮片炒白芍（批号20250101）、吴茱萸(批号20240701)经监督抽检，不符合《中国药典》（2020年版）一部规定。处罚依据依据《中华人民共和国药品管理法》第一百一十七条处罚类别罚款、没收违法所得、没收非法财物处罚内容1.没收涉案吴茱萸139.591kg；2.没收违法所得155049.44元；3.处罚款323070.06元。罚款金额（万元）32.307006万元没收违法所得、没收非法财物的金额（万元）1.没收违法所得金额15.504944万元2.没收非法财物的金额0.6460万元处罚决定日期2025年12月19日处罚机关四川省药品监督管理局处罚机关统一社会信用代码11510000MB1808933T

行政相对人名称四川原上草中药饮片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(统一社会信用代码)915106815775772698法定代表人罗应武行政处罚决定书文号川药监罚决〔2025〕2009号违法行为类型《中华人民共和国药品管理法》第九十八条违法事实当事人生产销售的中药饮片葛根（批号：241001）、淫羊藿（批号：250102），经监督抽检，不符合《中国药典》（2020年版）一部规定。处罚依据依据《中华人民共和国药品管理法》第一百一十七条处罚类别罚款、没收违法所得、没收非法财物处罚内容1.没收涉案药品葛根9.5公斤、淫羊藿2.5公斤;2.没收违法所得63061.55元；3.罚款200000元。罚款金额（万元）20万元没收违法所得、没收非法财物的金额（万元）1.没收违法所得金额6.306155万元2.没收非法财物的金额0.061285万元处罚决定日期2025年12月19日处罚机关四川省药品监督管理局处罚机关统一社会信用代码11510000MB1808933T

山东东魅商贸有限公司违反《药品经营质量管理规范》规定，存在质量安全隐患，山东省药品监督管理局依据《中华人民共和国药品管理法》第九十九条规定，对该企业采取了暂停销售药品的风险控制措施。现该企业已按要求进行了整改，通过整改后复查，基本符合《药品经营质量管理规范》要求，决定解除暂停销售药品的风险控制措施。山东省药品监督管理局2025年12月23日

根据《中华人民共和国食品安全法》和《保健食品注册与备案管理办法》等法律、规章的规定，湖南九典制药股份有限公司、湖南好益多乳业有限公司各提交了1个国产保健食品备案的申请材料，予以备案。特此公示。产品名称备案人备案人地址备案号备注久悦佳®锌硒多种维生素片湖南九典制药股份有限公司长沙市浏阳经济技术开发区健康大道1号食健备G202543003570好益多牌钙口服液(蓝莓味)湖南好益多乳业有限公司湖南宁乡蓝月谷西路88号食健备G202543003720

Delivery Method:Via EmailProduct:DrugsRecipient:Fernando AriasOwnerPrime Sports Nutrition4800 White Ln., Suite GBakersfield,CA93309United Statesinfo@shopteamprime.cominfo@primesportsnutrition.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERDecember 12, 2025RE: 719433Fernando Arias:This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at https://primesportsnutrition.com/ in November 2025. The FDA has observed that you offer products marketed on your firm’s website as selective androgen receptor modulators (SARMs) including, but not limited to, “LGD-4033” (also referred to on your website as “Ligandrol”), “RAD-140” (also referred to on your website as “Testolone”), “MK-677” (also referred to on your website as “Ibutamoren”), and “S-23” (hereinafter products marketed as SARMs) for sale in the United States. Based on our review, these products are unapproved new drugs under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). As explained further below, introducing or delivering these products for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).FDA has safety concerns about products that contain SARMs. Life-threatening reactions, including liver toxicity, have occurred in people taking products containing SARMs. SARMs also have the potential to increase the risk of heart attack and stroke.1Despite statements on your product labeling marketing some of your products as a “RESEARCH COMPOUND” and “NOT FOR HUMAN CONSUMPTION,” evidence obtained from your product labeling, including your website, establishes that your products are intended to be drugs for human use. Based on a review of your website, your products marketed as SARMs are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure or any function of the body. Examples from your product labeling, including on your website, that provide evidence of the intended use (as defined in 21 CFR 201.128) of these products as drugs include, but may not be limited to, the following:LGD-4033 LigandrolOn the webpage https://primesportsnutrition.com/products/lgd-4033-galactic-plus:“Looking To Build Lean Mass And Improving Strength While Maximizing Your Fat Loss Potential. LGD-4033 Has You Covered. LGD Is A Selective Androgen Receptor Modulator (SARM) That Usually Goes By The Name Ligandrol. It’s Known For Its Muscle Mass And Strength Increasing Properties That Actually Don’t Come With The Anabolic Side Effects. This Is What Makes It So Popular With Bodybuilders And Athletes. Ligandrol Acts Similar To An Anabolic Based Substance. It Has The Ability To Rapidly Increase Muscle Mass While Reducing Overall Body Fat. Increased Muscle Mass And An Increase In Strength Are Both Results Of The Selective Activation Of Androgen Receptors In The Muscles.”“KEY BENEFITSo Improves Muscle Masso Improve Staminao Burns Body Fato Boosts Testosterone”RAD-140 TestoloneOn the webpage https://primesportsnutrition.com/products/galactic-plus-duo-mk677-rad140-1?_pos=4&_sid=9711d0e06&_ss=r:“RAD140 + MK677 is A Very Popular Pairing.”“Many Across The World Are Admiring RAD-140 For Countless Reasons. Testolone RAD140 Was Designed As A Safer Alternative To Anabolics. This Highly Anabolic Compound Promotes Increases In Muscle Mass And Is Second To None For Mimicking The Effects Of Natural Testosterone.”“Benefits Of Testolone (RAD140)o Anabolic To Androgenic Ratio of 90:1o Improves Libido And Sexual Performanceo Best SARM For Muscle Growth And Size.o Reduces Fat And Increases Muscle Mass.o Ideal To Enhance Body Composition.o Rapid Muscle Recovery”“Medical Studies Have Demonstrated (And As Confirmed By Online Reviews About Testolone) That RAD-140 Is Highly Effective To Treat Degenerative Conditions Like Alzheimer's Disease. It Is Equally Effective To Provide Relief To Subjects With Androgenic Deficiencies.”“Individuals Treated With Testolone Have Reported Improvements In The Levels Of Sexual Development And Function.”“The Use Of Testolone Is Associated By RAD-140 Users With Dramatic Relief From Muscle Wasting Or Loss Or Muscle Tissue, Weakness, And Fatigue That Makes The Entire Otherwise-Complicated Processes Of Healing And Recovery Easy And Quick.”“RAD-140 Users Can Expect Dramatic Fat Loss And Gain 5-15 Lbs Lean Muscle Mass Gains In As Short As Four To Six Weeks.”MK-677 IbutamorenOn the webpage https://primesportsnutrition.com/products/galactic-plus-duo-mk677-rad140-1?_pos=4&_sid=9711d0e06&_ss=r:“Benefits Of Ibutamoren (MK-677)o Increases Muscle Mass and Strengtho Improves Tissue Regenerationo Increases Growth Hormone Levelso Clinically Proven GH Elevatoro Enhanced Vitality And Faster Recoveryo Reduces Body Fato Increases Sleep Quality And Rapid Eye Movement (REM) Sleepo Increases Insulin-Like Growth Factor 1 (IGF-1)o Improves Basal Metabolic Rate”“MK-677 + RAD 140 is Normally Used 12 Weeks”S-23On the webpage https://primesportsnutrition.com/products/s23-galactic-plus-1:“Looking To Boost Strength While Obliterating Fat? Let Us Introduce You To S23! One Of The Most Potent SARMs On The Market, Some Say That S-23 Is The Closest Thing To Conventional Steroids That You Can Get. An Excellent Cutting Compound, It Boosts Fat Loss Whilst Offering Impressive Lean, Dry Gains. This Compound Is Renowned For Developing A Dense, Hard Aesthetic With No Water Retention. If You’re Looking For Grainy-Looking Muscles, Then You Should Definitely Consider S-23.”“KEY BENEFITSo Muscle Mass Increaseo Fat Losso Increased Enduranceo Recover Times Are Shorter.”Your products marketed as SARMs are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective (GRASE) for use under the above-described conditions prescribed, recommended, or suggested in their 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). No approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for these products. Accordingly, these products are unapproved new drugs. The introduction or delivery for introduction into interstate commerce of these unapproved new drug products violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).ConclusionThe violations cited in this letter are not intended to be an all-inclusive statement of violations that may 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. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may lead to regulatory or legal action including, without limitation, seizure and injunction.Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to correct any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. 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. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.Your response should be sent to U.S. Food and Drug Administration, CDER/OC/Office of Unapproved Drugs and Labeling Compliance by email to FDAAdvisory@fda.hhs.gov. Please include your firm name and the unique identifier “719433” in the subject line of the email.Sincerely,/S/Tina Smith, M.S.Captain, U.S. Public Health ServiceDirectorOffice of Unapproved Drugs and Labeling ComplianceOffice of ComplianceCenter for Drug Evaluation and ResearchFood and Drug Administration______________________________1See https://www.fda.gov/consumers/consumer-updates/fda-warns-use-selective-androgen-receptor-modulators-sarms-among-teens-young-adults.

行政相对人名称巴彦县第三药店行政相对人代码(统一社会信用代码)912301268309219171法定代表人甘国红行政处罚决定书文号巴彦市监处罚〔2025〕96号违法行为类型违反了《中华人民共和国药品管理法》第五十五条的规定违法事实巴彦县第三药店非法渠道购进药品的行为，违反了《中华人民共和国药品管理法》第五十五条的规定。处罚依据依据《中华人民共和国药品管理法》第一百二十九条、《中华人民共和国行政处罚法》第五条第二款、《黑龙江省药品行政处罚裁量基准清单》序号13的规定处罚类别没收违法所得;罚款处罚内容1.没收违法所得48元；2.罚款10万元整。罚款金额（万元）10没收违法所得没收非法财物的金额（万元）0.0048处罚决定日期2025-12-23处罚有效期2099-12-31公示截止期2028-12-23处罚机关巴彦县市场监督管理局

　　按照《中华人民共和国药品管理法》《中华人民共和国行政许可法》和《药品经营和使用质量监督管理办法》等相关规定，根据河南泽坤医药有限公司申请，现注销河南泽坤医药有限公司的《药品经营许可证》（证书编号：豫AA371000645）。　　特此公告。　　附件：河南泽坤医药有限公司《药品经营许可证》有关信息表　　2025年12月23日附 件河南泽坤医药有限公司《药品经营许可证》（批发）有关信息表企业名称企业法人（负责人）质量负责人经营方式经营范围经营地址仓库地址证书编号河南泽坤医药有限公司刘敬昌(梁周全)张欣批发中药饮片、中成药、化学药***河南省郑州市金水区花园路126号1号楼18层1811号、17层1709号河南省郑州航空港经济综合试验区华夏大道与通航路交叉口西北角贰仟家物流总部园内《药品经营许可证》（证号：豫AA371000645）

Delivery Method:Via EmailReference #:320-26-29Product:Drugs、Over-the-Counter DrugsRecipient:Mr. Zhou YigangProduction ManagerGuangdong Renhe Guozhuang Biotechnology Co., Ltd.No. 5, Tongfu Road, Xicheng Industrial AreaRenhe TownBaiyun QuGuangzhou ShiGuangdong Sheng,510080ChinaIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter320-26-29December 16, 2025Your facility is registered with the United States Food and Drug Administration (FDA) as a manufacturer of over-the-counter (OTC) drug products. FDA has reviewed the records you submitted in response to our April 28, 2025 request and subsequent correspondence, for records and other information pursuant to section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) for your facility, Guangdong Renhe Guozhuang Biotechnology Co., Ltd, FEI 3030384816 at No. 5, Tongfu Road, Xicheng Industrial Area, Renhe Town, Baiyun District, Guangzhou Guangdong, China.This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations, parts 210 and 211 (21 CFR, parts 210 and 211).Because your methods, facilities, or controls for manufacturing, processing, packing, or holding of drugs as described in your response to our 704(a)(4) request do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 351(a)(2)(B)).Following review of records and other information provided pursuant to section 704(a)(4) of the FD&C Act, significant violations were observed including, but not limited to, the following1. 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) drug products including sterile(b)(4). Based on the records and information you provided, you did not demonstrate that you adequately test your OTC finished drug products prior to release for distribution to the United States.In your initial response, you state that you test each batch of your finished drug products before release. On June 23, 2025, FDA specifically requested that you provide the test data; however, in response to this request, you failed to provide the requested information to demonstrate that your finished products are tested prior to release.Full release testing, including for identity, strength, and impurities, must be performed prior to drug release and distribution. Without adequate testing, there is no 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 reserve 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 reserve 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 conduct at least one test to verify the identity of each component of a drug product (21 CFR 211.84(d)(1)).Based on the records and information you provided, you did not demonstrate that you adequately performed identity testing on incoming components including, but not limited to,(b)(4), which are at high-risk of(b)(4)contamination. Identity testing for these 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 sufficient identity testing, you failed to assure the acceptability of these components for use in 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).In your initial response, you state that you or your contract laboratory performed identity testing on each shipment of each lot of components before they were released for use in manufacturing. On June 23, 2025, FDA specifically requested that you provide the test data; however, in response to this communication you failed to provide any records demonstrating that you tested your incoming components before use in manufacturing.Without adequate testing, you do not have scientific evidence that incoming components conform to appropriate specifications prior to use in the manufacture of your drugs. As a manufacturer, you have a responsibility to sample, test, and examine incoming materials before use in production to assure adequate quality.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 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 comprehensive, independent review of your material system to determine whether all suppliers of incoming materials 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 materials.The chemical and microbiological quality control specifications you use to test and release each incoming lot of components for use in manufacturing.A description of how you will test each incoming material lot for conformity with all appropriate specifications for identity. If you intend to accept any results from your supplier’s certificate of analysis (COA) instead of testing each incoming material lot for other tests, specify how you will ensure that you have adequate evidence to establish that the supplier consistently provides material meeting specifications. In addition, include a commitment to always conduct at least one specific identity test for each incoming material lot.A summary of results obtained from testing all incoming materials to evaluate the reliability of the COA from each incoming materials 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 drugs you manufacture.3. 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)).Lack of Process ValidationIn your response, you stated that no validation activities have been performed for your drug products.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 industryProcess Validation: General Principles and Practicesfor general principles and approaches that the FDA considers appropriate elements of process validation at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/process-validation-general-principles-and-practices.Inadequate(b)(4)SystemIn your initial response, you state that you qualified your(b)(4)system. On June 23, 2025, FDA specifically requested that you provide the test data; however, in response to this communication you failed to provide any records demonstrating that the(b)(4)system has been qualified or appropriately tested. Also, it appears that you do not perform adequate chemical or microbiological analysis to determine suitability of or monitor the(b)(4)generated for use in drug manufacturing.(b)(4)is an ingredient in 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. See FDA’s(b)(4)In response to this letter, provide:A timeline for performing appropriate process performance qualification for each of your marketed drug products. Also include an explanation how you will ensure proper satisfactory process performance qualification studies are performed prior to future distribution of any drug products.Your process performance protocol(s) and written procedures for qualification of equipment and facilities.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.A procedure governing your program for ongoing control, maintenance, and monitoring that ensures the remediated system consistently produce(b)(4)that meets(b)(4)USP monograph specifications and appropriate microbiological limits. Include action/alert limits for total counts and objectionable organisms used for your(b)(4)system.A procedure for your(b)(4)system monitoring that specifies routine chemical and microbiological testing of(b)(4)to ensure its acceptability for use in each batch of drug products produced by your firm. Ensure that the total microbiological count limits for your(b)(4)are appropriately stringent in view of the intended use of each of the products produced by your firm.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/regulatory-information/search-fda-guidance-documents/quality-systems-approach-pharmaceutical-current-good-manufacturing-practice-regulations.CGMP Consultant RecommendedBased upon the nature of the violations, we identified at your firm, you should engage a consultant qualified as set forth in 21 CFR 211.34 to evaluate your operations and to assist your firm in meeting CGMP requirements. The qualified consultant should also perform a comprehensive six-system audit of your entire operation for CGMP compliance and evaluate the completion and efficacy of your corrective actions and preventive actions before you pursue resolution of your firm’s compliance status with FDA.Your use of a consultant does not relieve your firm’s obligation to comply with CGMP. Your firm’s executive management remains responsible for resolving all deficiencies and systemic flaws to ensure ongoing CGMP compliance.ConclusionThe violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations.FDA placed all drugs and drug products offered for import into the United States from your firm on Import Alert 66-40 on November 12, 2025.Correct any violations promptly. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP. We may inspect to verify that you have completed corrective actions to any violations.Failure to address any violations may also result in the FDA continuing to refuse admission of articles manufactured at Guangdong Renhe Guozhuang Biotechnology Co., Ltd., No. 5, Tongfu Road, Xicheng Industrial Area, Renhe Town, Guangzhou, 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 3030384816 and ATTN: Chhaya Shetty.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and Research

Delivery Method:VIA EMAIL WITH READ RECEIPTReference #:320-26-27Product:DrugsRecipient:Mr. Clifford CliveCEOMedinatura New Mexico, Inc.10421 Research Road SEAlbuquerque,NM87123United StatesIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter320-26-27December 10, 2025Dear Mr. Clive:The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Medinatura New Mexico, Inc., FEI 1626962, at 10421 Research Road SE, Albuquerque, New Mexico, from May 19 to May 23, 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 June 6, 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:1. Your firm failed to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality. Your firm also failed to validate and establish the reliability of your component supplier’s test analyses at appropriate intervals (21 CFR 211.84(d)(1) and 211.84(d)(2)).You failed to perform adequate identity testing on each shipment of each lot of incoming components (for example,(b)(4)) used in the manufacture of your homeopathic drug products. Your firm’s testing was limited to Identification(b)(4)(specific gravity) and you failed to adequately test your incoming component(b)(4), used as an active pharmaceutical ingredient (API), for(b)(4). In addition, you relied on your suppliers’ certificates of analysis (COAs) without establishing the reliability of your component suppliers’ test analyses at appropriate intervals.Products containing(b)(4)You manufacture multiple drugs that contain(b)(4). The use of(b)(4)contaminated with(b)(4)has resulted in various lethal poisoning incidents in humans worldwide. See FDA’s guidance document(b)(4).In your response, you stated that your firm was not following the current United States Pharmacopeia (USP) requirements for(b)(4)identification testing. USP pharmaceutical standards are applicable to drugs, including drug components, such as(b)(4), of finished pharmaceuticals, per section 501(b) of the FD&C Act.Your response is inadequate. It does not provide sufficient details about how you will establish the reliability of your component suppliers’ COAs at appropriate intervals. Furthermore, it does not indicate you will perform the required testing for each lot of incoming raw materials. Your response also lacks an appropriate and thorough risk assessment of the quality of previously distributed drug products that are within expiry.In response to this letter, provide:A commitment to provide(b)(4)test results, as applicable, 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, marketed finished drug product batches for the presence of(b)(4), as applicable.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 marketed drug product that could contain(b)(4), including customer notifications and product recalls for any contaminated lots. Identify additional appropriate corrective action and preventive action (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 suppliers’ certificate of analysis (COA) instead of testing each component lot for strength, quality, and purity, specify how you will robustly establish the reliability of your suppliers’ 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.The chemical and microbiological quality control specifications you use to test each incoming lot of drug components to determine acceptability for use in manufacturing, including but not limited to,(b)(4).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 your program for qualifying and overseeing contract facilities that test the drug products you manufacture.A summary of results obtained from testing all components to evaluate the reliability of the COA from each component manufacturer. Include your standard operating procedures (SOP) that describes this COA validation program.2. Your firm failed to establish and follow adequate written procedures for cleaning and maintenance of equipment (21 CFR 211.67(b)).Your cleaning validation program for non-dedicated manufacturing equipment, used for multiple drug products, is inadequate. It does not include the equipment used in tablet manufacturing, such as Intermediate Bulk Container (IBC) tanks(b)(4)tanks, product transfer hoses and(b)(4)hoses. Additionally, your firm lacks equipment usage logs and cleaning documentation, to ensure that the equipment is adequately cleaned and to prevent carry-over contamination from a prior batch during production campaigns.In your response, you acknowledge that the cleaning validation is not reflective of your current operations, because you continued to purchase new equipment and add new drug products to your operations. You stated that you recognize that the cleaning validation needs a comprehensive revision.Your response is inadequate. You have not provided sufficient details about your updated cleaning validation and associated procedures. You also did not provide a risk assessment of the quality of your distributed drugs, which are potentially contaminated because of your inadequate cleaning practices.In response to this letter, provide the following: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 finished product.A 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 execution for all products and equipment; and all other needed remediations.Appropriate improvements to your cleaning validation program, with special emphasis on incorporating conditions identified as worst-case in your drug manufacturing operation. This should include, but not be limited to, identification and evaluation of all worst-case:o Drugs with higher toxicitieso Drugs with higher drug potencieso Drugs of lower solubility in their cleaning solventso Drugs with characteristics that make them difficult to cleano Swabbing locations for areas that are most difficult to cleano Maximum hold times before cleaningIn addition, describe the steps that must be taken in your change management system before introduction of new manufacturing equipment or a new product.A summary of updated SOP that ensure an appropriate program is in place for verification and validation of cleaning procedures for products, processes, and equipment.3. 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 (21 CFR 211.100(a)).You have not adequately validated your production and process controls used to manufacture your homeopathic drug products, including “(b)(4)tablets” and “(b)(4),” which are labeled for(b)(4). Your drug products contain potentially hazardous components (for example,(b)(4)).In your response, you acknowledged that you have not been properly updating your process validations when new drug products and equipment are added, and your last official validation study was completed in 2007, when the company was under different ownership. You committed to using your current manufacturing data to update your process validation.Your response is inadequate. You did not provide details about how you will conduct process validation for all your products, including the products containing potentially hazardous components. Also, you did not provide a risk assessment and any follow-up actions to be taken for distributed drug products produced without performing appropriate process validation.Process validation evaluates the soundness of design and state of control of a process throughout its lifecycle. Each significant stage of a manufacturing process must be designed appropriately and assure the quality of raw material inputs, in-process materials, and finished drugs. Process qualification studies include intensive monitoring and testing throughout each significant process stage to characterize intra-batch variation and evaluate batches to determine whether an initial state of control has been established. Successful process qualification studies are necessary before commercial distribution. Thereafter, ongoing vigilant oversight of process performance and product quality is necessary to ensure you maintain a stable manufacturing operation throughout the product lifecycle.See FDA’s guidance documentProcess Validation: General Principles and Practicesfor general principles and approaches that FDA considers appropriate elements of process validation at https://www.fda.gov/media/71021/download.In response to this letter, provide the following: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. Also, provide a risk assessment and any follow-up actions to be taken for the distributed drug products produced without performing appropriate process validation studies.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.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, 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.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.CGMP Consultant RecommendedBased upon the nature of the violations we identified at your firm, we strongly recommend engaging a consultant qualified as set forth in 21 CFR 211.34 to assist your firm in meeting CGMP requirements. We also recommend that the qualified consultant perform a comprehensive audit of your entire operation for CGMP compliance and evaluate the completion and efficacy of your CAPA before you pursue resolution of your firm’s compliance status with FDA.Your use of a consultant does not relieve your firm’s obligation to comply with CGMP. Your firm’s executive management remains responsible for resolving all deficiencies and systemic flaws to ensure ongoing CGMP compliance.ConclusionThe violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations.Correct any violations promptly. Failure to promptly and adequately address this matter may result in regulatory or legal action without further notice including, without limitation, seizure and injunction. Unresolved violations may also prevent other Federal agencies from awarding contracts.Failure to address violations may also cause FDA to withhold issuance of Export Certificates. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to address any violations.This letter notifies you of our findings and provides you an opportunity to address the above deficiencies. After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any violations and to prevent their recurrence. In response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion.Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 1626962 and ATTN: Chhaya Shetty.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and Research