行政相对人名称：东莞市快德好医药有限公司清溪北环分店行政相对人类别：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91441900MA551GWW5F44***********67法人代表姓名：邱锦亮法定代表人证件类型：法定代表人证件号码：行政处罚决定书文号：东市监处罚〔2025〕160103013号违法行为类型：《药品经营质量管理规范》第一百二十五条,《药品经营质量管理规范》第一百二十五条第二款“企业应当按照国家有关规定配备执业药师，负责处方审核，指导合理用药。”。《中华人民共和国药品管理法》第五十三条违法事实：经查明，2024年10月09日我局执法人员依法对东莞市快德好医药有限公司清溪北环分店进行检查，情况如下：1、该店正在营业中，负责人在场配合检查，现场提供营业执照、药品经营许可证。2、在该店现场未发现执业药师在场，执法人员现场用手机登录“广东食品药品服务教育网”网站进行查询，原注册执业药师已变更到其他药店，在此网站查询不到任何执业药师备案到该店。当事人对上述现场检查情况无异议，已于2024年10月31日备案执业药师，并提交备案的执业药师注册证给我局。当事人于2024年01月18日因从事药品经营活动,未配备执业药师被我局作出当场行政处罚决定给予警告。处罚依据：《中华人民共和国药品管理法》第一百二十六条“除本法另有规定的情形外，药品上市许可持有人、药品生产企业、药品经营企业、药物非临床安全性评价研究机构、药物临床试验机构等未遵守药品生产质量管理规范、药品经营质量管理规范、药物非临床研究质量管理规范、药物临床试验质量管理规范等的，责令限期改正，给予警告；逾期不改正的，处十万元以上五十万元以下的罚款；情节严重的，处五十万元以上二百万元以下的罚款，责令停产停业整顿直至吊销药品批准证明文件、药品生产许可证、药品经营许可证等，药物非临床安全性评价研究机构、药物临床试验机构等五年内不得开展药物非临床安全性评价研究、药物临床试验，对法定代表人、主要负责人、直接负责的主管人员和其他责任人员，没收违法行为发生期间自本单位所获收入，并处所获收入百分之十以上百分之五十以下的罚款，十年直至终身禁止从事药品生产经营等活动。”处罚类别：罚款处罚内容：罚款人民币贰仟元整（2000）。罚款金额（万元）：0.2没收违法所得、 没收非法财物的金额：暂扣或吊销证照名称及编号：处罚决定日期：2025-01-03公示截止期：2028-01-03处罚机关：东莞市市场监督管理局数据来源单位：东莞市市场监督管理局相关推荐CIO提供以下相关文库下载、合规服务以及线上培训课程学习。

行政相对人名称：东莞市济德堂药业有限公司清溪谢坑分店行政相对人类别：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91441900MA56H0CG1N44***********81法人代表姓名：林苗法定代表人证件类型：法定代表人证件号码：行政处罚决定书文号：东市监处罚〔2025〕160103012号违法行为类型：《药品经营质量管理规范》第一百二十五条,《药品经营质量管理规范》第一百二十五条第二款“企业应当按照国家有关规定配备执业药师，负责处方审核，指导合理用药。”。《中华人民共和国药品管理法》第五十三条违法事实：经查明，2024年10月08日我局执法人员依法对东莞市济德堂药业有限公司清溪谢坑分店进行检查，情况如下：1、该店正在营业中，店长朱丽珍在场配合检查，现场提供营业执照、药品经营许可证。2、在该店现场未发现执业药师在场，执法人员现场用手机登录“广东食品药品服务教育网”网站进行查询，原注册执业药师已变更到其他药店，在此网站查询不到任何执业药师备案到该店。当事人对上述现场检查情况无异议，已于2024年10月31日备案执业药师，并提交备案的执业药师注册证给我局。当事人于2024年01月19日因从事药品经营活动,未配备执业药师被我局作出当场行政处罚决定给予警告。处罚依据：《中华人民共和国药品管理法》第一百二十六条“除本法另有规定的情形外，药品上市许可持有人、药品生产企业、药品经营企业、药物非临床安全性评价研究机构、药物临床试验机构等未遵守药品生产质量管理规范、药品经营质量管理规范、药物非临床研究质量管理规范、药物临床试验质量管理规范等的，责令限期改正，给予警告；逾期不改正的，处十万元以上五十万元以下的罚款；情节严重的，处五十万元以上二百万元以下的罚款，责令停产停业整顿直至吊销药品批准证明文件、药品生产许可证、药品经营许可证等，药物非临床安全性评价研究机构、药物临床试验机构等五年内不得开展药物非临床安全性评价研究、药物临床试验，对法定代表人、主要负责人、直接负责的主管人员和其他责任人员，没收违法行为发生期间自本单位所获收入，并处所获收入百分之十以上百分之五十以下的罚款，十年直至终身禁止从事药品生产经营等活动。”处罚类别：罚款处罚内容：罚款人民币贰仟元整（2000）。罚款金额（万元）：0.2没收违法所得、 没收非法财物的金额：暂扣或吊销证照名称及编号：处罚决定日期：2025-01-03公示截止期：2028-01-03处罚机关：东莞市市场监督管理局数据来源单位：东莞市市场监督管理局相关推荐CIO提供以下相关文库下载、合规服务以及线上培训课程学习。

行政相对人名称：广东康多多医药连锁有限公司东莞清溪三中分店行政相对人类别：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91441900MA55RWX13K44***********56法人代表姓名：王海丰法定代表人证件类型：法定代表人证件号码：行政处罚决定书文号：东市监处罚〔2025〕160103010号违法行为类型：《药品经营质量管理规范》第一百二十五条,《药品经营质量管理规范》第一百二十五条第二款“企业应当按照国家有关规定配备执业药师，负责处方审核，指导合理用药。”。《中华人民共和国药品管理法》第五十三条违法事实：经查明，2024年10月09日我局执法人员依法对广东康多多医药连锁有限公司东莞清溪三中分店进行检查，情况如下：1、该店正在营业中，店长在场配合检查，现场提供营业执照、药品经营许可证。2、在该店现场未发现执业药师在场，执法人员现场用手机登录“广东食品药品服务教育网”网站进行查询，原注册执业药师已变更到其他药店，在此网站查询不到任何执业药师备案到该店。当事人对上述现场检查情况无异议，已于2024年10月23日备案执业药师，并提交备案的执业药师注册证给我局。当事人于2024年01月17日因从事药品经营活动,未配备执业药师被我局作出当场行政处罚决定给予警告。处罚依据：《中华人民共和国药品管理法》第一百二十六条“除本法另有规定的情形外，药品上市许可持有人、药品生产企业、药品经营企业、药物非临床安全性评价研究机构、药物临床试验机构等未遵守药品生产质量管理规范、药品经营质量管理规范、药物非临床研究质量管理规范、药物临床试验质量管理规范等的，责令限期改正，给予警告；逾期不改正的，处十万元以上五十万元以下的罚款；情节严重的，处五十万元以上二百万元以下的罚款，责令停产停业整顿直至吊销药品批准证明文件、药品生产许可证、药品经营许可证等，药物非临床安全性评价研究机构、药物临床试验机构等五年内不得开展药物非临床安全性评价研究、药物临床试验，对法定代表人、主要负责人、直接负责的主管人员和其他责任人员，没收违法行为发生期间自本单位所获收入，并处所获收入百分之十以上百分之五十以下的罚款，十年直至终身禁止从事药品生产经营等活动。”处罚类别：罚款处罚内容：罚款人民币贰仟元整（2000）。罚款金额（万元）：0.2没收违法所得、 没收非法财物的金额：暂扣或吊销证照名称及编号：处罚决定日期：2025-01-03公示截止期：2028-01-03处罚机关：东莞市市场监督管理局数据来源单位：东莞市市场监督管理局相关推荐CIO提供以下相关文库下载、合规服务以及线上培训课程学习。

行政相对人名称哈尔滨华尚冠宇大药房有限公司行政相对人代码(统一社会信用代码)91230104585122934P法定代表人邹文键行政处罚决定书文号道里市监处罚〔2025〕43号违法行为类型违反《药品经营和使用质量监督管理办法》第四十二条 第五款：药品零售企业营业时间内，依法经过资格认定的药师或者其他药学技术人员不在岗时，应当挂牌告知。未经依法经过资格认定的药师或者其他药学技术人员审核，不得销售处方药。违法事实哈尔滨华尚冠宇大药房有限公司我局已于2024年10月25日下达责令改正通知书（文书编号：哈里市监爱建改字〔2024〕067号），并要求该药店于2024年11月1日前改正。2024年11月5日，我局执法人员到哈尔滨华尚冠宇大药房有限公司进行监督检查，检查你药店处方药销售记录显示在2024年11月5日15点20分销售盐酸左氧氟沙星片1盒（标示山东罗欣药业集团股份有限公司生产、规格12片/盒批号6240550132）经查询该药店处方销售记录时间与电子处方开方时间不一致，并在销售上述处方药时，该药店执业药师不在岗，存在未凭处方销售处方药的违法行为。处罚依据《药品经营和使用质量监督管理办法》 / 第七十二条 / 第一项　　　　药品零售企业有以下情形之一的，由药品监督管理部门责令限期改正；逾期不改正的，处五千元以上五万元以下罚款；造成危害后果的，处五万元以上二十万元以下罚款：　　（一）未按规定凭处方销售处方药的；处罚类别罚款处罚内容依据《药品经营和使用质量监督管理办法》第七十二条第一款第三项：“药品零售企业有以下情形之一的,由药品监督管理部门责令限期改正;逾期不改正的，处五千元以上五万元以下罚款；造成危害后果的，处五万元以上二十万元以下罚款”之规定，建议责令当事人立即改正违法行为，拟处罚如下： 罚款5,000.00元。罚款金额（万元）0.5处罚决定日期2025-02-01处罚有效期2099-12-31公示截止期2028-02-01处罚机关哈尔滨市道里区市场监督管理局相关推荐CIO提供以下相关文库下载、合规服务以及线上培训课程学习。

行政相对人名称四川金方生物医药科技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)91511621399522969E法定代表人唐宜彬行政处罚决定书文号川药监处罚〔2024〕4004号违法行为类型《中华人民共和国药品管理法》违法事实当事人生产销售假药中药饮片“山药”的行为，违反了《中华人民共和国药品管理法》第九十八条第一款的规定。处罚依据《中华人民共和国行政处罚法》第二十八条、《中华人民共和国药品管理法》第一百一十六条和第一百一十八条处罚类别罚款、没收违法药品、没收违法所得处罚内容责令改正违法行为，并予以如下处罚：（一）没收中药饮片“山药”（批号：230501）7kg；（二）没收金方公司违法所得74003.5元；（三）对金方公司处以货值金额（不足十万元的按十万元计）三倍的罚款30万元。（以上罚没款合计374003.5元）（四）没收法定代表人、企业负责人唐宜彬2024年4月至8月违法行为发生期间自金方公司所获收入22130.34元，并处所获收入百分之十的罚款2213.03元。（罚没款合计24343.37元）（五）没收质量负责人、质量受权人王杰2024年4月至8月违法行为发生期间自金方公司所获收入17870.34元，并处所获收入百分之十的罚款1787.03元。（罚没款合计19657.37元）罚款金额（万元）30.400006没收违法所得、没收非法财物的金额（万元）11.403418处罚决定日期2024年12月30日处罚机关四川省药品监督管理局处罚机关统一社会信用代码11510000MB1808933T相关推荐CIO提供以下相关文库下载、合规服务以及线上培训课程学习。

Delivery Method:Via Electronic Mail - Delivery and Read Receipt RequestedReference #:320-25-31Product:DrugsRecipient:Ms. Sezin ZavaroHead of the BoardKardesler Ucan Yaglar Sanayi Anonim SirketiInonu Mah Gebze Plastikciler OSBMah 42 Sokak No:141400Gebze/KocaeliTurkeyIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter320-25-31January 21, 2025Dear Ms. Zavaro:Your facility was recently 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 March 15, 2024 request, and subsequent requests, 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, Kardesler Ucan Yaglar Sanayi Anonim Sirketi, FEI 3012634391, at Inonu Mah Gebze Plastikciler OSB, Mah 42 Sokak No: 1, Gebze/Kocaeli 41400, Turkey.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 responses to our 704(a)(4) requests do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act (21 U.S.C. 351(a)(2)(B)).704(a)(4) Request for Records and Related CGMP ViolationsFollowing 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 following:1. 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)).You manufacture OTC drug products such as hand sanitizing wipes. Based on the records and information you provided, you did not demonstrate that you adequately tested the identity of incoming components used in the manufacture of your drug products.Glycerin & Propylene GlycolInformation provided indicated that you failed to adequately test each shipment of each lot of glycerin and propylene glycol for identity, components at higher risk for diethylene glycol (DEG) and ethylene glycol (EG) contamination. Identity testing of glycerin and propylene glycol, along with other high-risk drug components1, include a limit test in the United States Pharmacopeia (USP) to ensure that the component meets the relevant safety limits for levels of DEG or EG. Because you did not perform identity testing on each shipment of each glycerin and propylene glycol lot using the USP identification tests that detect these hazardous impurities, you failed to assure the acceptability of these components for use in the manufacture of your drug products.The use of ingredients contaminated with DEG or EG has resulted in various lethal poisoning incidents in humans worldwide. See FDA’s guidance documentTesting of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated Starch Hydrolysate, Sorbitol Solution, and Other High-Risk Drug Components for Diethylene Glycol and Ethylene Glycolto help you meet the CGMP requirements when manufacturing drugs containing ingredients at high-risk for DEG or EG contamination athttps://www.fda.gov/media/167974/download.EthanolYou failed to demonstrate that you adequately test your incoming ethanol, used as an active ingredient, for methanol. The use of ethanol contaminated with methanol has resulted in various lethal poisoning incidents in humans worldwide. See FDA’s guidance documentPolicy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanolto help you meet the CGMP requirements when manufacturing drugs containing ethanol athttps://www.fda.gov/media/173005/downloadWithout adequate testing, you do not have scientific evidence that your components conform to appropriate specifications prior to use in the manufacture of your drug products.2. Your firm failed to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release (21 CFR 211.165(a)).Based on the records and information you provided, you did not demonstrate that you adequately tested your drug products for the identity and strength of the active ingredients prior to release and distribution. For example, your responses did not demonstrate that you tested the identity or strength of ethanol or benzalkonium chloride in your finished drug products.Testing is an essential part of CGMP to ensure that the drug products you manufacture conform to all pre-determined quality attributes appropriate for their intended use. Drug products must be tested for identity and strength of the active ingredient, prior to release and distribution. Without adequate testing, you do not have scientific evidence to assure that your drug products conform to appropriate specifications before release.3. Your firm failed to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products (21 CFR 211.22(a)).The records and information you provided did not demonstrate that your quality unit (QU) effectively exercised its responsibilities to oversee the quality of your drug manufacturing operations. For example, your QU did not adequately exercise its authority in the approval or rejection of components in your Materials System.Your QU is responsible for fully exercising its authority and responsibilities. FDA is concerned that your QU may not be conducting appropriate oversight regarding other CGMP operations, including Production, Facilities & Equipment, Laboratory Controls, and Packaging & Labeling Systems.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 athttps://www.fda.gov/media/71023/download.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.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 your firm on Import Alert 66-40 January 14, 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 Kardesler Ucan Yaglar Sanayi Anonim Sirketi, Inonu Mah Gebze Plastikciler OSB, Mah 42 Sokak No: 1, Gebze/Kocaeli 41400, Turkey, 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.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 3012634391 and ATTN: Joel Hustedt.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and ResearchCC:Registered U.S. AgentLiberty Management Group Ltd.Mr. Manoj ZachariasEmail: manoj@libertymanagement.us________________________1Components with higher risk of DEG or EG contamination compared to other drug components.

Delivery Method:Via EmailProduct:DrugsRecipient:Michael LeeMihon Corp. d/b/a VitalityVita and Boulla, LLC1332 4th St. Suite BBerkeley,CA94710United Statesllcboulla@gmail.comboullallc@proton.mevitalityvita@gmail.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERJanuary 16, 2025RE: 698165Dear Michael Lee:This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address https://vitalityvita.com from August to December 2024 and your product listings on your Amazon storefronts at https://www.amazon.com/gp/product/B0CXTX9X8R/ref=ox_sc_act_title_1?smid=A2QN00MS00FLEE&psc=1 and https://www.amazon.com/ZoomMax-Nutrition-Maximize-Stamina-Vigorous/dp/B0D4SDCGZM/ref=sr_1_4_sspa?dib=eyJ2IjoiMSJ9.6CSIXY89VWyHbQ%E2%80%A6 in October 2024. The FDA has observed that your website and your Amazon storefronts offer the products “VitalityXtra,” “PeakMax,” “ZapMax,” and “ZoomMax” for sale in the United States. In addition, FDA has obtained samples of your “VitalityXtra,” “PeakMax,” “ZapMax,” and “ZoomMax” products. As described below, these products 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). Furthermore, these products are misbranded drugs under section 502 of the FD&C Act, 21 U.S.C. 352, introduced or delivered for introduction into interstate commerce in violation of section 301(a) of the FD&C Act, 21 U.S.C. 331(a).FDA confirmed through laboratory analyses that samples of your “VitalityXtra,”1“PeakMax,”2“ZapMax,”3and “ZoomMax,”4purchased from your before-noted websites, contain undeclared active pharmaceutical ingredient (API) sildenafil. Additionally, laboratory analyses identified the presence of undeclared API diclofenac in your “PeakMax,” “ZapMax, and “ZoomMax” products.Sildenafil is a phosphodiesterase type-5 (PDE-5) inhibitor and the active ingredient in the FDA-approved prescription drug Viagra used to treat erectile dysfunction (ED). This undeclared API may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels. People with diabetes, high blood pressure, high cholesterol, or heart disease, often take nitrates.Diclofenac is a non-steroidal anti-inflammatory drug (commonly referred to as NSAIDs). NSAIDs may cause increased risk of cardiovascular events, such as heart attack and stroke, as well as serious gastrointestinal damage, including bleeding, ulceration, and fatal perforation of the stomach and intestines. This hidden drug ingredient may also interact with other medications and significantly increase the risk of adverse events, particularly when consumers use multiple NSAID-containing products.Information on the labels and/or labeling of your “VitalityXtra,” “PeakMax,” “ZapMax,” and “ZoomMax” demonstrate that the products are marketed as dietary supplements.5Under sections 201(ff)(3)(B)(i) and (ii) of the FD&C Act, 21 U.S.C. 321(ff)(3)(B)(i) and (ii), if an article is an active ingredient in a drug product that has been approved under section 505 of the FD&C Act, 21 U.S.C. 355, or has been authorized for investigation as a new drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, then products containing that substance are outside the definition of a dietary supplement. There is an exception if the substance was “marketed as” a dietary supplement or as a conventional food before the new drug investigations were authorized.FDA approved Viagra (containing sildenafil as the active pharmaceutical ingredient) as a new drug on March 27, 1998. FDA approved diclofenac, under the trade name Voltaren, as a new drug on July 28, 1988. Given that sildenafil and diclofenac were not marketed as dietary supplements or as foods before Viagra or Voltaren were FDA-approved, “VitalityXtra,” “PeakMax,” “ZapMax,” and “ZoomMax,” which contain sildenafil or sildenafil and diclofenac, are excluded from the definition of “dietary supplement” under section 201(ff)(3)(B)(i) of the FD&C Act.Unapproved New DrugsYour “VitalityXtra,” “PeakMax,” “ZapMax,” and “ZoomMax” products are drugs as defined by 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 of claims from the labeling that provide evidence of the intended use of these products as drugs include, but may not be limited to, the following:VitalityXtraFrom the product label:• “Strength”• “Stamina”• “Endurance”From your product webpage https://www.vitalityvita.com/products/vitalityxtra-male-supplement-for-endurance-vitality-energy-stamina-and-strength-fast-acting-physical-performance-10-count-per-pack:• “VitalityXtra, Male Supplement for Endurance, Vitality, Energy, Stamina, and Strength”• “Boost your energy for higher vitality.”• “[I]ncrease your endurance, and enhance your over health.”• “Greater endurance and stamina”PeakMaxFrom your product webpage https://www.vitalityvita.com/products/peak-max-male-supplement-for-endurance-vitality-energy-10-count-per-pack?variant=45112925454499:• “Male Supplement for Endurance, Vitality, Energy”• “Are you looking to boost your vitality, endurance, drive, and stamina when you need it the most? Well, look no further! Our amazing blue pill supplement is here to help.”ZapMaxFrom your product listing at https://www.amazon.com/gp/product/B0CXTX9X8R/ref=ox_sc_act_title_1?smid=A2QN00MS00FLEE&psc=1• “[F]or Energy and Endurance”ZoomMaxFrom your product listing at https://www.amazon.com/ZoomMax-Nutrition-Maximize-Stamina-Vigorous/dp/B0D4SDCGZM/ref=sr_1_4_sspa?dib=eyJ2IjoiMSJ9.6CSIXY89VWyHbQ%E2%80%A6• “Our natural herbal blend helps maximize demands for sports and other physical activity. Our natural ingredients helps [sic] your body improve its endurance and stamina to perform longer at your peak performance. It also improves your energy by raising your body's vigor and energy. Lastly, feel the improved physical strength.”“VitalityXtra,” “PeakMax,” “ZapMax,” and “ZoomMax” are not generally recognized as safe and effective for the above referenced uses and, therefore, are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p). Subject to certain exceptions not applicable here, a new drug may not be legally introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a). No FDA-approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355 are in effect for these products. Accordingly, the introduction or delivery for introduction into interstate commerce of these products violate sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).Misbranded DrugYour “VitalityXtra,” “PeakMax,” “ZapMax,” and “ZoomMax” products are misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a). Under section 502(a) of the FD&C Act, 21 U.S.C. 352(a), a drug is misbranded if its labeling is false or misleading in any particular. Section 201(n) of the FD&C Act, 21 U.S.C. 321(n), provides that, in determining whether an article’s labeling or advertising “is misleading there shall be taken into account…not only representations made or suggested…but also the extent to which the labeling or advertising fails to reveal facts material in light of such representations.” The labeling for “VitalityXtra,” “PeakMax,” “ZapMax,” and “ZoomMax” products do not declare that the products contain a PDE-5 inhibitor or diclofenac. The failure to disclose these ingredients in the product labeling renders your “VitalityXtra,” “PeakMax,” “ZapMax” and “ZoomMax” products misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a).Your “VitalityXtra,” “PeakMax,” “ZapMax,” and “ZoomMax” products are also misbranded under section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1), in that their labeling fails to bear adequate directions for use. “Adequate directions for use” means directions under which a layman can use a drug safely and for the purposes for which it is intended (see 21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1) of the FD&C Act, 21 U.S.C. 353(b)(1), include those that, because of their toxicity or other potentiality for harmful effect, and/or the method of their use, and/or the collateral measures necessary for their use, are not safe for use except under supervision of a practitioner licensed by law to administer them. All PDE-5 inhibitors which have been approved for marketing by FDA are limited by an approved new drug application to use under the supervision of a practitioner licensed by law to administer such drugs. Your “VitalityXtra,” “PeakMax,” “ZapMax,” and “ZoomMax” products, which contain undeclared sildenafil, are prescription drugs as defined in section 503(b)(1)(A) of the FD&C Act, 21 U.S.C. 353(b)(1)(A), and as such, can be used safely only at the direction, and under the supervision, of a licensed practitioner. Therefore, it is impossible to write “adequate directions for use” for your “VitalityXtra,” “PeakMax,” “ZapMax,” and “ZoomMax” products such that a layperson can use the drugs safely for their intended uses. “VitalityXtra,” “PeakMax,” “ZapMax,” and “ZoomMax” products are not exempt from the requirements that their labeling bears adequate directions for use by a layperson, 21 CFR 201.100(c)(2) and 201.115, because there are no FDA approved applications in effect for these products. For these reasons, your “VitalityXtra,” “PeakMax,” “ZapMax,” and “ZoomMax” products are misbranded under section 502(f)(1) of the FD&C Act.The undeclared active pharmaceutical ingredients in your products also causes these products to be misbranded under section 502(f)(2) of the FD&C Act, 21 U.S.C. 352(f)(2), because their labeling lacks adequate warnings for the protection of users. As previously noted, there is potential for serious health risks associated with these products, particularly since anyone who takes your “VitalityXtra,” “PeakMax,” “ZapMax,” and “ZoomMax” products would be unaware of the presence of the undeclared drug ingredients and placed at risk for their associated adverse events.The introduction or delivery for introduction into interstate commerce of these misbranded drugs is a prohibited act under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).A list of tainted products discovered by FDA can be found at https://www.fda.gov/consumers/health-fraud-scams/health-fraud-product-database.ConclusionThis letter is 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 result in 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.Sincerely,/S/Tina Smith, M.S.Captain, U.S. Public Health ServiceDirectorOffice of Unapproved Drugs & Labeling ComplianceOffice of ComplianceCenter for Drug Evaluation and ResearchU.S. Food and Drug Administration__________________________1U.S. Food & Drug Administration, Public Notification: VitalityXtra may be harmful due to hidden drug ingredients, (November 8, 2024), https://www.fda.gov/drugs/medication-health-fraud/vitalityxtra-may-be-harmful-due-hidden-drug-ingredient.2U.S. Food & Drug Administration, Public Notification: PeakMax may be harmful due to hidden drug ingredients, (November 8, 2024), https://www.fda.gov/drugs/medication-health-fraud/peakmax-may-be-harmful-due-hidden-drug-ingredients.3U.S. Food & Drug Administration, Public Notification: ZapMax may be harmful due to hidden drug ingredients, (November 8, 2024), https://www.fda.gov/drugs/medication-health-fraud/zapmax-may-be-harmful-due-hidden-drug-ingredients.4U.S. Food & Drug Administration, Public Notification: ZoomMax may be harmful due to hidden drug ingredients, (November 8, 2024), https://www.fda.gov/drugs/medication-health-fraud/zoommax-may-be-harmful-due-hidden-drug-ingredients.5The labeling of these products contains a Supplement Facts panel.

Delivery Method:VIA UPS and Electronic MailReference #:CBER-25-698004Product:BiologicsRecipient:Joy Kong, M.D.Chief Executive OfficerChara Biologics, Inc.9568 Topanga Canyon Blvd., Suite 104Chatsworth,CA91311United States(b)(6)Issuing Office:Center for Biologics Evaluation and Research (CBER)United StatesWARNING LETTERJanuary 17, 2025CBER 25-698004Dear Dr. Kong:The United States Food and Drug Administration (FDA) inspected your facility, Chara Biologics, Inc., located at the above address, between July 23, 2024, and August 16, 2024. During the inspection, FDA documented that Chara Biologics, Inc. (“you”) manufactures and distributes a human amniotic fluid product, CharaExo, as well as cellular products derived from human umbilical cord, CharaCore and CharaOmni, for allogeneic use (collectively, “your products”).1This letter is to advise you that your products are unapproved new drugs in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 355(a). Your products are also unlicensed biological products in violation of section 351(a)(1) of the Public Health Service Act (PHS Act), 42 U.S.C. § 262(a)(1). A biological product for which a biologics license application (BLA) has been approved under section 351(a) of the PHS Act is not required to have an approved application under section 505 of the FD&C Act, 21 U.S.C. § 355; 42 U.S.C. § 262(j). Otherwise, 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. Your introduction or delivery for introduction of your products into interstate commerce, or the causing thereof, is prohibited under section 301(d) of the FD&C Act, 21 U.S.C. § 331(d).This warning letter also summarizes significant violations of current good manufacturing practice (CGMP) requirements, including violations of section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. § 351(a)(2)(B), and 21 CFR parts 210 and 211. Your firm is responsible for ensuring that your products comply with CGMP requirements regardless of who manufactures, processes, packs, or holds them. This letter also explains you are in violation of current good tissue practice (CGTP) requirements set forth in 21 CFR part 1271 in the manufacture of your CharaCore and CharaOmni products. Because your methods, facilities, or controls for manufacturing, processing, packing, or holding drugs do not conform to CGMP, your products are adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. § 351(a)(2)(B). Furthermore, CharaExo is also misbranded under sections 502(a) of the FD&C Act, 21 U.S.C. § 352(a). Your introduction or delivery for introduction of your products into interstate commerce, or the causing thereof is a prohibited act under section 301(a) of the FD&C Act, 21 U.S.C. § 331(a).Unapproved New Drug and Unlicensed Biological Product ViolationsBased on information and records reviewed by FDA, your products are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease or conditions in humans. For example:• CharaExo o Chara Biologics’ brochure, “Let the Joy of Healing Begin,” tells prospective customers to choose its products because “Chara offers the most comprehensive stem cell product CharaCore and high potency growth factor/extracellular vesicle product CharaExo.” It explains that “stem cells have been shown to have clinical benefits in” a long list of conditions including various autoimmune disorders, “neurodegenerative conditions (Parkinson’s, Alzheimers, Multiple Sclerosis, ALS, etc.)”, diabetes, cardiovascular and lung diseases, autism, spinal cord injuries, and cirrhosis. It also explains stem cell treatment can benefit its audience by reducing inflammation, improving immune function, and enhancing tissue repair. o AAICT “Exosome Protocols” provide sample CharaExo dosing for the following diseases or conditions: Infertility, Osteoporosis, Diabetes, Autism, Cardiac, Renal, Hepatic, Pulmonary conditions, etc…. Musculoskeletal…Shoulder/Hip/Knees…Ligaments/Tendons/Meniscus /Labrum… Elbow/Wrist/Ankle/Fingers… Spine…Erectile Dysfunction… Female Urinary Incontinence…Autoimmune Diseases… Neuropathy… CNS Disease… Wound, Ulcers & Burns…” These protocols, which are part of AAICT’s Fundamentals of Stem Cell Practice course, accompany Chara Biologics’ CharaExo products when Chara Biologics sells them to physicians as part of Starter Package 3. o Chara Biologics’ “FAQs for Physicians,” which you said you provide all your purchasing physicians, explains: “CharaExo also contains larger extracellular vesicles, as well as concentrated growth factors from amniotic fluid… Extracellular vesicles contain proteins, microRNAs and lipids, and all eukaryotic cells secrete and take up these nanoparticles, and they are a means of communication between cells. These nanoparticles have been increasingly recognized as playing an important role as the mediator of many of the MSC-associated therapeutic benefits. They can be quite useful therapeutically, as they may elicit a more immediate therapeutic response, although the benefits tend to be shorter-lasting than that of cell therapy.”• CharaCore o Statements in Chara Biologics’ “Let the Joy of Healing Begin” brochure (discussed above) o Chara Biologics’ FAQ for Physicians includes the following statements:  “CharaCore® is highly rich in MSC’s…MSC’s: have anti-microbial properties, helpful in fighting acute, chronic or systemic infections… shown to be effective against protozoa (as in Lyme disease)”  “How Can CharaCore help my patients? REGULATE INFLAMMATION, SCARRING & PAIN Birth tissue products have been shown to reduce inflammation, fibrous tissue growth, and potential scar tissue formation.”  “How Can CharaCore help my patients? ANTI-MICROBIAL Application of birth tissue products has been shown to reduce bacteria counts in the wound…”• CharaOmni o Chara Biologics’ FAQ for Physicians and CharaOmni promotional brochure state: “[W]hat set[s] CharaOmni apart from all other skincare products on the market: 1) Regenerative Stem Cell Components… Wharton’s Jelly Extract… reduces scar formation, and enhances wound healing…. Amniotic Extracellular Matrix - possesses powerful anti-inflammatory...properties.” o Your website at www.charaomni.com explains “The stem cell regenerative elements in CharaOmni… have been known to provide crucial and powerful growth factors, extracellular matrix, as well as other cell signaling molecules that highly beneficial in skin repair and regeneration.”• Chara Biologics also promotes its products for the following diseases at www.charabiologics.com/science, which links to https://aaict.org/clinical-evidence/: o “…Alzheimer’s…Asthma…Autism…Chronic Pain…COPD…Crohn’s Disease…Degenerative Disc Disease…Heart Disease…Kidney Failure…Liver Cirrhosis…Lupus…Macular Degeneration…Migraines & Tension Headache…Multiple Sclerosis…Nerve Injury…Osteoarthritis… Osteoporosis…Parkinson’s…”Therefore, CharaExo, CharaCore, and CharaOmni are drugs as defined in section 201(g)(1) of the FD&C Act, 21 U.S.C. § 321(g)(1), and biological products as defined in section 351(i) of the PHS Act, 42 U.S.C. § 262(i).Your CharaCore and CharaOmni products are also human cells, tissues, or cellular or tissue-based products (HCT/Ps) as defined in 21 CFR 1271.3(d) and are subject to regulation under 21 CFR part 1271, issued under the authority of section 361 of the PHS Act, 42 U.S.C. § 264.2HCT/Ps that do not meet all the criteria in 21 CFR 1271.10(a) are not regulated solely under section 361 of the PHS Act and the regulations in 21 CFR part 1271. Unless an exception in 21 CFR 1271.15 applies, such products are regulated as drugs, devices, and/or biological products under the FD&C Act and/or the PHS Act and are subject to additional regulation, including applicable premarket review. Based on a review of relevant materials, Chara Biologics, Inc. does not qualify for any exception in 21 CFR 1271.15, and your CharaCore and CharaOmni products fail to meet all criteria in 21 CFR 1271.10(a).For example, your CharaCore and CharaOmni products fail to meet the minimal manipulation criterion set forth in 21 CFR 1271.10(a)(1) and defined for structural tissue in 21 CFR 1271.3(f)(1), because the processing alters the original relevant characteristics of the umbilical cord related to its utility for reconstruction, repair, or replacement. The processing of the umbilical cord from the form of a conduit into a flowable form significantly alters the physical state of the HCT/P. The umbilical cord is more than minimally manipulated because such processing alters the original relevant characteristics of the HCT/P relating to its utility to serve as a conduit by effectively altering or eliminating its physical integrity and tubular form.In addition, your CharaCore and CharaOmni products fail to meet the criterion that the HCT/Ps be “intended for homologous use only,” which means that the “labeling, advertising, or other indications of the manufacturer’s objective intent” demonstrate that the HCT/P is intended to perform “the same basic function or functions in the recipient as in the donor” (21 CFR 1271.3(c) and 1271.10(a)(2)). These products are not intended solely to perform the same basic function or functions of the HCT/P in the recipient as in the donor (e.g., serving as a conduit). Rather, these products are intended for use in the treatment of a number of diseases and conditions listed above, which are not basic functions of umbilical cord in the donor.Therefore, these HCT/Ps are not regulated solely under section 361 of the PHS Act, 42 U.S.C. § 264, and the regulations in 21 CFR part 1271.3See 21 CFR 1271.20. In addition to being regulated under section 361 of the PHS Act and 21 CFR part 1271, your CharaCore and CharaOmni products are regulated as drugs as defined in section 201(g)(1) of the FD&C Act, 21 U.S.C. § 321(g)(1), and biological products as defined in section 351(i) of the PHS Act, 42 U.S.C. § 262(i), as stated above.Subject to certain exceptions not applicable here, to lawfully introduce or deliver for introduction into interstate commerce a drug that is a biological product, a valid BLA must be in effect under section 351(a)(1) of the PHS Act, 42 U.S.C. § 262(a)(1). Such licenses are issued only after showing that the product is safe, pure, and potent. Your products are not the subject of an approved BLA, nor is there an investigational new drug application (IND) in effect for any of them.CGMP and/or CGTP ViolationsFDA’s inspection of your facility documented evidence of significant CGMP and CGTP violations. At the conclusion of the inspection, the FDA investigators issued a Form FDA-483, List of Inspectional Observations (Form FDA-483). FDA also identified additional significant violations upon further review of the evidence collected during the inspection, as set forth below.The violations applicable to your products include, but are not limited to, the following:1. Your firm failed to establish a quality unit with the responsibility and authority to approve or reject all labeling and drug products, and the responsibilities and procedures applicable to the quality control unit are not in writing and followed, as required by 21 CFR 211.22(a) and 211.22(d).Your firm is a manufacturer subject to CGMP requirements. See 21 CFR 210.3(b)(12). For example, at the time of the inspection, your firm relabeled, stored, and distributed CharaCore and stored and distributed CharaOmni.4An adequate quality unit overseeing all elements of CGMP is necessary to ensure drug products are consistently manufactured in compliance with CGMP and meet established specifications for identity, strength, quality and purity. However, your firm does not receive documentation, such as production records or test results, for each lot received for approval or rejection by your firm before distribution. Additionally, your firm has not established responsibilities and procedures applicable to the quality unit such as the following:a. Laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity (21 CFR 211.160(b))b. Written procedures for production and process control designed to assure drug products have the identity, strength, quality, and purity purported or represented to possess (21 CFR 211.100(a))c. Review and approval of drug product production and control records, including those for packaging and labeling, to determine compliance with all established, approved written procedures before a batch is released or distributed (21 CFR 211.192)d. Written procedures describing the handling of all written and oral complaints regarding a drug product (21 CFR 211.198(a))e. Written procedures designed to assure that correct labels, labeling, and packaging are used (21 CFR 211.130)2. Documentation of the donor-eligibility determination, including the name of the responsible person who made the determination and the date of the determination, was not maintained, as required by 21 CFR 1271.55(d)(1)(iii).Specifically, Chara did not maintain documentation of the donor eligibility determination, including the name of the responsible person who made the determination and the date of the determination, for donors of umbilical cord. Umbilical cord is used to manufacture CharaCore, which is used to manufacture CharaOmni.Misbranding ViolationYour CharaExo product is also misbranded under section 502(a) of the FD&C Act, 21 U.S.C. § 352(a), because your labeling is false or misleading. Specifically, your firm extended the manufacturer’s expiration date for CharaExo lots by one year or more without supporting data. This false or misleading representation about your CharaExo product on your labeling causes this product to be misbranded under section 502(a) of the FD&C Act, 21 U.S.C. § 352(a).Response to the Form FDA-483We have reviewed your responses, received on September 1, 2024 and December 23, 2024,5to FDA’s Form FDA-483 in detail. Your responses are inadequate to address the violations noted above and on the Form FDA-483. While you assert that your products were manufactured according to section 361 of the PHS Act, the evidence collected shows that your products do not meet the relevant criteria to be regulated solely under section 361 of the PHS Act.We acknowledge that you state in your September and December 2024 responses that, “Chara Biologics is not [now], nor has it ever been a Stem Cell processor/manufacturer.” We also acknowledge that you state in your December 2024 response that an agreement has been made with “the manufacturers to label all products prior to coming into the building.” Be advised that manufacture, processing, packing, or holding of a drug product includes packaging and labeling operations, testing, and quality control of drug products. See 21 CFR 210.3(b)(12)6and 1271.3(e). Based on your responses, it appears that Chara continues to package, store, and distribute drug products. For the reasons described above, Chara Biologics is a manufacturer subject to applicable CGMP requirements. This is consistent with your signed affidavit from the inspection, in which you state, “Chara Biologics, Inc. – This is the primary manufacturing entity for the Chara products CharaCore, CharaExo and CharaOmni.”Be advised that Chara is responsible for ensuring its products are manufactured in compliance with CGMP. Drugs not manufactured in compliance with CGMP are adulterated. The FD&C Act prohibits any person from introducing or delivering for introduction an adulterated or misbranded drug into interstate commerce.We refer you to the following document for additional information,Guidance for Industry: Contract Manufacturing Arrangements for Drugs: Quality Agreements(November 2016), found at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/contract-manufacturing-arrangements-drugs-quality-agreements-guidance-industry. Also, be advised that, under the CGMP regulations, a “quality control unit shall be responsible for approving or rejecting drug products manufactured, processed, packed, or held under contract by another company.” 21 CFR 211.22(a).With respect to donor eligibility, you state in your response that your contract manufacturers determine donor eligibility for the HCT/Ps used for your products. However, you are required to retain the donor-eligibility determination of the tissue donors for products that remain in inventory at your facility or have been distributed and remain in the marketplace as required by 21 CFR 1271.55(d)(1)(iii).Your responses do not adequately address the status of your manufacturing and distribution operations or your specific plans for disposition of the inventory of CharaExo, CharaCore, and CharaOmni at your facility that were manufactured under the conditions described in this letter. This includes the disposition of finished product received from your contract manufacturers prior to being re-labeled by your firm. Further, your responses do not adequately describe actions you have taken or plan to take to address the impact of the above-described deficiencies on your distributed products that remain in the marketplace. Your responses do not address your failure to have an IND in effect to study your products addressed in this letter or your lack of an approved BLA to lawfully market your products. Subject to certain exceptions not applicable here, to lawfully introduce or deliver for introduction into interstate commerce a drug that is a biological product, a valid BLA must be in effect under section 351(a)(1) of the PHS Act, 42 U.S.C. § 262(a)(1). Such licenses are issued only after showing that the product is safe, pure, and potent. Your products are not the subject of an approved BLA.FDA has previously provided notice to you in a letter dated November 25, 2019, that based on a review of your website it appeared your firm was marketing a biological drug product (CharaCore) that does not qualify for any exception under 21 CFR 1271.15, as is also explained in this letter. Your response dated December 17, 2019, stated that you would remove all testimonials from your websites. However, a review of your various social media accounts, which are linked to your websites, revealed patient testimonials for Chara Biologics that describe treatment of various diseases and conditions. In addition, your March 13, 2020, response stated your intention to(b)(4), however your products are not the subject of an approved BLA, nor is there an IND in effect for any of them.ConclusionNeither this letter nor the observations noted on the Form FDA-483, which were discussed with you at the conclusion of the inspection, are intended to be an all-inclusive list of deficiencies 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 full compliance with all applicable requirements in the FD&C Act, PHS Act, and all applicable regulations.This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address these matters may result in action without further notice including, without limitation, seizure and/or injunction.Please submit your response in writing within fifteen (15) working days from your receipt of this letter, outlining the specific steps you have taken or plan to take to address any violations and prevent their recurrence. Include any documentation necessary to show that the matters have been addressed. If you cannot address these matters within fifteen (15) working days, please explain the reason for your delay and the timeframe for completion. If you do not believe your products are in violation of the FD&C Act, PHS Act, or applicable regulations, include your reasoning and any supporting information for our consideration.Send your electronic response to CBERDCMRecommendations@fda.hhs.gov. If you have questions regarding this letter, contact the Division of Case Management, CBER at (240) 402-9156.Sincerely,/S/Melissa J. MendozaDirectorOffice of Compliance and Biologics QualityCenter for Biologics Evaluation and Research_________________________1We note that in addition to Chara Biologics, Inc., Dr. Kong also controls the American Academy of Integrative Cell Therapy, Inc. (AAICT), co-located at the same business address. These entities function together: Chara Biologics contracts with manufacturers to make its products, which Chara Biologics then relabels and distributes; and AAICT develops trainings, and training materials and protocols for Chara Biologics products, which are distributed with the products themselves.2We note that your amniotic fluid product, CharaExo, is not an HCT/P because amniotic fluid is a secreted bodily fluid and the definition of HCT/Ps in 21 CFR 1271.3(d)(3) excludes secreted or extracted human products.3Because CharaCore and CharaOmni fail to meet at least one criterion in 21 CFR 1271.10(a), this letter does not evaluate all criteria in 21 CFR 1271.10(a).4Manufacture, processing, packing, or holding of a drug product includes packaging and labeling operations, testing, and quality control of drug products per 21 CFR 210.3(b)(12).5Your written responses are dated August 26, 2024, October 14, 2024, November 13, 2024, and December 18, 2024.6See footnote 4.

主体名称诸暨市乾泰药店处罚决定书文号诸市监处罚﹝2025﹞94号处罚类别罚款;没收违法所得处罚决定时间2025-01-27处罚内容本局认为:当事人经营带有上述标签内容的“雄人”牌精品别直参的行为,违反了《中华人民共和国食品安全法》第七十一条第一款:“食品和食品添加剂的标签、说明书,不得含有虚假内容,不得涉及疾病预防、治疗功能。生产经营者对其提供的标签、说明书的内容负责”之规定,属经营标签涉及疾病预防、治疗功能的食品的行为,责令改正。鉴于当事人积极配合市场监督管理部门调查并主动提供证据材料,给予从轻处罚。根据《中华人民共和国食品安全法》第一百二十五条第一款第(二)项:“违反本法规定,有下列情形之一的,由县级以上人民政府食品安全监督管理部门没收违法所得和违法生产经营的食品、食品添加剂,并可以没收用于违法生产经营的工具、设备、原料等物品;违法生产经营的食品、食品添加剂货值金额不足一万元的,并处五千元以上五万元以下罚款;货值金额一万元以上的,并处货值金额五倍以上十倍以下罚款;情节严重的,责令停产停业,直至吊销许可证:……(二)生产经营无标签的预包装食品、食品添加剂或者标签、说明书不符合本法规定的食品、食品添加剂”之规定,决定处罚如下:1.没收违法所得1500元;2.罚款5000元。罚款金额（万元）0.500000没收违法所得0.150000暂扣或吊销证照名称及编号-违法行为类型诸暨市乾泰药店生产经营的保健食品之外的食品的标签、说明书声称具有保健功能的行为案处罚依据《中华人民共和国食品安全法》第一百二十五条第一款第(二)项;违法事实主要违法事实:经查明:2019年12月7日,当事人诸暨市乾泰药店从某某保健品有限公司处以3.8元/克的价格购进20盒“雄人”牌精品别直参(每盒1条共20条,总重量为300克)。上述别直参的生产商为某某保健品有限公司,其外包装的标签上标注了“【功能】大补元气、复脉固脱,补脾益肺,生津止渴、安神益智”的字样,故该食品的标签信息涉及疾病预防、治疗功能。当事人在明知上述“雄人”牌精品别直参的食品标签内容不符合规定的情况下,于购进当天开始将上述“雄人”牌精品别直参放在位于浙江省诸暨市大唐街道***号的经营场所中,以整盒的规格称重后对外销售,具体价格为5元/克。于2024年5月29日被本局查获。至查获时止,当事人已将上述20盒共300克“雄人”牌精品别直参销售完毕,共计货值金额1500元,违法所得1500元。行政处罚种类、依据、内容:本局认为:当事人经营带有上述标签内容的“雄人”牌精品别直参的行为,违反了《中华人民共和国食品安全法》第七十一条第一款:“食品和食品添加剂的标签、说明书,不得含有虚假内容,不得涉及疾病预防、治疗功能。生产经营者对其提供的标签、说明书的内容负责”之规定,属经营标签涉及疾病预防、治疗功能的食品的行为,责令改正。鉴于当事人积极配合市场监督管理部门调查并主动提供证据材料,给予从轻处罚。根据《中华人民共和国食品安全法》第一百二十五条第一款第(二)项:“违反本法规定,有下列情形之一的,由县级以上人民政府食品安全监督管理部门没收违法所得和违法生产经营的食品、食品添加剂,并可以没收用于违法生产经营的工具、设备、原料等物品;违法生产经营的食品、食品添加剂货值金额不足一万元的,并处五千元以上五万元以下罚款;货值金额一万元以上的,并处货值金额五倍以上十倍以下罚款;情节严重的,责令停产停业,直至吊销许可证:……(二)生产经营无标签的预包装食品、食品添加剂或者标签、说明书不符合本法规定的食品、食品添加剂”之规定,决定处罚如下:1.没收违法所得1500元;2.罚款5000元。行政处罚履行方式和期限:当事人自收到行政处罚决定书之日起十五日内,按照行政处罚决定书载明的履行方式履行。处罚机关诸暨市市场监督管理局处罚机关统一社会信用代码11330681307304121J数据来源单位省市场监管局数据来源单位统一社会信用代码11330000MB19062420相关推荐CIO提供以下相关文库下载、合规服务以及线上培训课程学习。

主体名称永嘉县金氏药品零售有限公司处罚决定书文号永市监处罚﹝2025﹞47号处罚类别罚款处罚决定时间2025-01-27处罚内容当事人销售过期医疗器械的行为违反了《医疗器械监督管理条例》第五十五条之规定,依据《医疗器械监督管理条例》第八十六条第(三)项之规定,本局决定对当事人作如下处理:1.没收过期壳聚糖痔疮洗液1瓶;2.罚款21000元。罚款金额（万元）2.100000没收违法所得0.000000暂扣或吊销证照名称及编号-违法行为类型永嘉县金氏药品零售有限公司经营无合格证明文件、过期、失效、淘汰的医疗器械案处罚依据《医疗器械监督管理条例》第八十六条第三项　有下列情形之一的,由负责药品监督管理的部门责令改正,没收违法生产经营使用的医疗器械;违法生产经营使用的医疗器械货值金额不足1万元的,并处2万元以上5万元以下罚款;货值金额1万元以上的,并处货值金额5倍以上20倍以下罚款;情节严重的,责令停产停业,直至由原发证部门吊销医疗器械注册证、医疗器械生产许可证、医疗器械经营许可证,对违法单位的法定代表人、主要负责人、直接负责的主管人员和其他责任人员,没收违法行为发生期间自本单位所获收入,并处所获收入30%以上3倍以下罚款,10年内禁止其从事医疗器械生产经营活动:　　　　(三)经营、使用无合格证明文件、过期、失效、淘汰的医疗器械,或者使用未依法注册的医疗器械;　　;违法事实主要违法事实:被处罚人销售过期医疗器械行政处罚种类、依据、内容:当事人销售过期医疗器械的行为违反了《医疗器械监督管理条例》第五十五条之规定,依据《医疗器械监督管理条例》第八十六条第(三)项之规定,本局决定对当事人作如下处理:1.没收过期壳聚糖痔疮洗液1瓶;2.罚款21000元。行政处罚履行方式和期限:当事人自收到行政处罚决定书之日起十五日内,按照行政处罚决定书载明的履行方式履行。处罚机关永嘉县市场监督管理局处罚机关统一社会信用代码11330324002534006L数据来源单位省市场监管局数据来源单位统一社会信用代码11330000MB19062420相关推荐CIO提供以下相关文库下载、合规服务以及线上培训课程学习。