Delivery Method:VIA Electronic MailReference #:320-25-29Product:DrugsRecipient:Mr. David M. RoseCEO and Co-OwnerAtlanta Supersource, Inc.3655 Kennesaw 75 Parkway NW, Suite 100Kennesaw,GA30144-6502United StatesIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter320-25-29January 8, 2025Dear Mr. Rose:The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Atlanta Supersource, Inc., FEI 3016837288, located at 3655 Kennesaw 75 Parkway NW, Suite 100, Kennesaw from July 15 to 19, 2024.This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 211).Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).In addition, INSTANT HAND SANITIZER Rinse-Free Gel and INSTANT HAND SANITIZER Rinse-Free Foam are misbranded under sections 502(a) of the FD&C Act, 21 U.S.C. 352(a). Introduction or delivery for introduction of such products into interstate commerce is prohibited under sections 301(a) of the FD&C Act, 21 U.S.C. 331(a). These violations are described in more detail below.We acknowledge receipt of your response to our Form FDA 483. Your response is inadequate because it did not provide sufficient detail or evidence of corrective actions to bring your operations into compliance with CGMP.During our inspection, our investigator observed specific violations including, but not limited to, the following.CGMP Violations1. Your firm failed to clean, maintain, and, as appropriate for the nature of the drug, sanitize and/or sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements (21 CFR 211.67(a)).Your firm manufactures topical over the counter (OTC) hand sanitizer drug products. You also manufacture commercial industrial chemical products, labeled with warnings such as “cause severe skin burns” and “may cause allergic skin reactions,” on the same manufacturing equipment as your OTC drug products.It is unacceptable as a matter of CGMP to manufacture drugs using the same equipment that you use to manufacture these toxic industrial grade products due to the risk of cross-contamination.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)).Your firm failed to adequately test your drug products for the identity and strength of the active ingredient, benzalkonium chloride (BZK), prior to release and distribution.Full release testing, including for identity and strength must be performed prior to batch 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 test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality (21 CFR 211.84(d)(1) and 211.84(d)(2)).You failed to conduct an identity test on each shipment of each lot of components used in the manufacture of your drug products, (e.g., BZK,(b)(4)). You also failed to determine whether each component conformed with all appropriate written specifications for purity, strength, and quality before using them.Without adequate testing, you do not have scientific evidence that the components conform to appropriate specifications before use in the manufacture of your drug products.Additionally, your firm uses water as a component in your drug products. Your water system is not adequately monitored to ensure that it can produce water that meets United States Pharmacopeia (USP) purified water monograph specifications.Water for pharmaceutical purposes must be suitable for its intended use and routinely tested to ensure ongoing conformance with appropriate chemical and microbiological attributes.Misbranding Violations“SuperSource INSTANT HAND SANITIZER Rinse Free Gel” and “SuperSource INSTANT HAND SANITIZER Rinse-Free Foam” are drugs as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or under section 201(g)(1)(C) of the FD&C Act, 21 U.S.C. 321(g)(1)(C), because they are intended to affect the structure or any function of the body.Examples of claims observed on the “SuperSource INSTANT HAND SANITIZER Rinse-Free Gel” and “SuperSource INSTANT HAND SANITIZER Rinse-Free Foam” product label provide evidence of the intended uses (as defined in 21 CFR 201.128) of the product include, but may not be limited to, the following:“SuperSource INSTANT HAND SANITIZER Rinse Free Gel” “Uses: may help reduce bacteria that potentially can cause disease.” [from product label]“SuperSource INSTANT HAND SANITIZER Rinse-Free Foam” “Uses: may help reduce bacteria that potentially can cause disease.” [from product label]The labeling for such drugs, like all OTC drugs, must comply with all of the requirements of section 502 of the FD&C Act and all pertinent regulations found in Title 21 of the Code of Federal Regulations (21 CFR).However, “SuperSource INSTANT HAND SANITIZER Rinse Free Gel” and “SuperSource INSTANT HAND SANITIZER Rinse-Free Foam” are misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a), because the products’ labels include the statement “MADE IN AN FDA REGISTERED FACILITY” and the acronym “FDA” in the statement is in a form that is similar to the FDA logo. FDA’s regulations provide that “[r]egistration of an establishment or listing of a drug does not denote approval of the establishment, the drug, or other drugs of the establishment, nor does it mean that a product may be legally marketed” (21 CFR 207.77(a)). However, the general public is not likely to be familiar with the details of FDA’s regulations. The assertion that your products were “Made in an FDA Registered Facility,” have an “Approved FDA formulation,” combined with your use of the acronym FDA in a form that is similar to the FDA logo on a product label misleadingly suggests that the drug products are approved or endorsed by FDA in some way. Your “SuperSource INSTANT HAND SANITIZER Rinse Free Gel” and “SuperSource INSTANT HAND SANITIZER Rinse-Free Foam” products are not the subjects of an FDA-approved application. Therefore, these products are misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a), because their labeling is false or misleading.The introduction or delivery for introduction of a misbranded drug into interstate commerce violates section 301(a) of the FD&C Act, 21 U.S.C. 331(a).Cosmetics Manufactured for Distribution in the United StatesIn addition, we note that some of the products you manufacture may be regulated as cosmetics, as defined in section 201(i) of the FD&C Act [21 U.S.C. 321(i)]. Any cosmetics you manufacture must comply with applicable statutory and regulatory requirements, including the FD&C Act. Under section 301(a) of the FD&C Act [21 U.S.C. 331(a)], it is a prohibited act to introduce or deliver for introduction into interstate commerce a cosmetic that is adulterated or misbranded.Further, your facility may be subject to requirements of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). Information on MoCRA requirements may be found athttps://www.fda.gov/cosmetics/cosmetics-laws-regulations/modernization-cosmetics-regulation-act-2022-mocra.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 athttps://www.fda.gov/media/71023/download.CGMP Consultant RecommendedWe acknowledge your commitment to “discontinue production of all hand sanitizer (products regulated by the FDA).” However, as of the date of this letter, your website at https://supersourceinc.com/market-segments/#rs includes a statement that promotes the sale of hand sanitizer, “We provide several products for the equipment, and hand sanitizers to keep employees clean.” Additionally, your website at https://supersourceinc.com/products-chemicals/ includes a product listing and image promoting “Hand Sanitizer.” In response to this letter, clarify whether you intend to resume manufacturing any drugs at this facility or any other facility in the future.If you plan to resume any manufacturing operations regulated under the FD&C Act, notify this office before resuming your drug manufacturing operations. Based upon the nature of the violations we identified at your firm, if you resume manufacturing drugs 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.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 3016837288 and ATTN: Joel Hustedt.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and Research/S/Tina SmithCaptain, U.S. Public Health ServiceDirectorOffice of Unapproved Drugs & Labeling ComplianceOffice of ComplianceCenter for Drug Evaluation and Research

济南尚润通达复合材料有限公司报告，由于产品可能存在部分性能指标不符合技术要求的风险等原因，济南尚润通达复合材料有限公司对其生产的远红外理疗贴（注册或备案号：鲁械注准20222091012）主动召回。召回级别为三级。涉及产品的型号、规格及批次等详细信息见《医疗器械召回事件报告表》。附件：医疗器械召回事件报告表 2025年01月21日

行政相对人名称常州市康福莱医疗用品有限公司行政相对人类别法人及非法人组织统一社会信用代码91320402251026395D工商注册号组织机构代码税务登记号事业单位证书号社会组织登记证号法定代表人施建兴法定代表人证件类型身份证法定代表人证件号码3****************4证件类型证件号码行政处罚决定书文号苏药监常处字〔2024〕18号违法行为类型违反了《医疗器械监督管理条例》第三十六条违法事实该单位停产期间生产了“一次性使用无菌注射器带针”产品处罚依据《医疗器械监督管理条例》第八十八条、《中华人民共和国行政处罚法》第二十八条处罚类别罚款处罚内容1.罚款人民币壹万伍仟元（15000元）。罚款金额（万元）1.5没收违法所得没收非法财物的金额（万元）暂扣或吊销证照名称及编号处罚决定日期2025/01/21处罚有效期2025/07/21公示截止期2025/04/21处罚机关江苏省药品监督管理局处罚机关统一社会信用代码11320000014000394R数据来源单位江苏省药品监督管理局数据来源单位统一社会信用代码11320000014000394R备注公示截止期依据文件：市场监督管理行政处罚信息公示规定相关推荐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。

主体名称宁波市海辰药品零售有限公司海曙集士港店处罚决定书文号甬海市监处罚﹝2025﹞25号处罚类别罚款处罚决定时间2025-01-21处罚内容责令解聘,罚款。;罚款金额（万元）3.478329没收违法所得0.000000暂扣或吊销证照名称及编号-违法行为类型宁波市海辰药品零售有限公司海曙集士港店其它违法行为案处罚依据《中华人民共和国药品管理法》第一百四十条药品上市许可持有人、药品生产企业、药品经营企业或者医疗机构违反本法规定聘用人员的,由药品监督管理部门或者卫生健康主管部门责令解聘,处五万元以上二十万元以下的罚款。;违法事实主要违法事实:经查明:当事人系一家有限责任公司分公司,主要进行药品零售,总公司为宁波市海辰药品零售有限公司,总公司的法定代表人和分公司的责任人都是徐某某。执法人员曾于2024年8月28日、9月2日和9月18日分别对总公司及当事人进行日常检查。8月28日检查当天发现当事人注册执业药师江某某不在岗,但已有处方药销售记录,且处方上盖有江某某私章。经询问,当事人承认该药师实际未正常履职负责处方审核等工作,且当事人无法提供与该药师签订的用工合同和工资发放记录,只能提供一份银行的电子回单,电子回单显示总公司曾于2024年8月19日向江某某转账6600元,附言:24年6月1日到24年11月30日。江某某与总公司签署有退休返聘意向协议,协议期限为两年,自2024年4月1日开始,岗位是门店质量负责人兼医保管理。江某某从2024年4月19日取得中华人民共和国执业药师注册证,执业单位:当事人店里,是当事人店内唯一的一位执业药师。总公司和当事人并未与江某某签订用工合同。江某某于2024年5月1日早上8点左右到当事人店内确认经营情况,同时店里开始公示江某某的执业药师注册证,但店里情况与江某某预期不符,因此江某某从2024年5月2日起没有再来过当事人店里,退休返聘协议也因此作废。从2024年5月1日到2024年9月18日,当事人共在线下销售处方药252单。其中处方药的采购总价为3465.16元,销售总价为8434.35元。从2024年5月1日到2024年9月18日,当事人共在线上销售处方药243单。其中处方药的采购总价为5823.61元,销售总价为6348.94元。在上述线上、线下销售处方药时,当事人以江某某的名义审核药方,江某某本人并不知情。总公司曾于2024年8月19日向江某某转账6600元,作为江某某从2024年6月1日到2024年11月30日在当事人店内暂挂执业药师注册证的费用,并与江某某口头约定,最晚于2024年11月30日之前注销其执业药师注册证。当事人于2024年10月21日提交整改报告,已经更换新的符合资质的执业药师,并承诺今后严格按照规定审核药方。经案件系统查询,当事人未曾发生过相同违法行为。行政处罚种类、依据、内容:一、当事人以江某某的名义审核药方的行为,违反了《药品经营和使用质量监督管理办法》第四十二条第五款之规定,构成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销售处方药的违法行为。二、当事人未进行处方审核调配而进行网络零售处方药的行为违反了《药品网络销售监督管理办法》第九条第二款的规定,构成药品网络零售企业未严格按照有关规定进行处方审核调配的违法行为。三、当事人违反《中华人民共和国药品管理法》规定聘用挂证执业药师的行为,违反了《中华人民共和国药品管理法》第五十二条第三项“从事药品经营活动应当具备以下条件:有与所经营药品相适应的质量管理机构或者人员”、第五十八条第三款“依法经过资格认定的药师或者其他药学技术人员负责本企业的药品管理、处方审核和调配、合理用药指导等工作”的规定,构成违规聘用执业药师的违法行为。自由裁量理由等其他需要说明的事项:第一、当事人违规聘用挂证执业药师的行为、未经执业药师审核销售处方药的违法行为以及药品网络零售企业未严格按照有关规定进行处方审核调配的违法行为,本质上是一个违法行为触犯多条法律规定,决定对上述行为进行处罚竞合,择一重处罚。二、关于江某某挂证期间违法所得的计算:从2024年5月1日到2024年9月18日,共在线上、线下销售处方药495单,其中处方药的采购总价为9288.77元,违法经营额共计14783.29元,违法所得共计14783.29元。三、鉴于当事人未曾发生过相同违法行为,积极配合市场监管部门调查,如实陈述违法事实并主动提供证据材料,没有造成严重危害后果,并于2024年10月21日提交整改报告,已经更换新的符合资质的执业药师,并承诺今后严格按照规定审核药方,因此决定对当事人减轻处罚。处理意见及依据:根据《中华人民共和国行政处罚法》第五条第二款、第二十八条第二款及《中华人民共和国药品管理法》第一百四十条之规定,决定责令当事人解聘该药师,并对当事人减轻处罚如下:1、没收违法所得14783.29元;2、罚款20000元。以上罚没款共计34783.29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。处罚机关宁波市海曙区市场监督管理局处罚机关统一社会信用代码11330203309059836N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。

主体名称慈溪市锦福药店处罚决定书文号慈市监处罚﹝2025﹞139号处罚类别罚款处罚决定时间2025-01-21处罚内容有下列情形之一的,由负责药品监督管理的部门责令改正,处1万元以上5万元以下罚款;拒不改正的,处5万元以上10万元以下罚款;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2倍以下罚款,5年内禁止其从事医疗器械生产经营活动:　　　　(二)生产、经营说明书、标签不符合本条例规定的医疗器械;;罚款金额（万元）1.000000没收违法所得0.000000暂扣或吊销证照名称及编号-违法行为类型慈溪市锦福药店经营标签、说明书不符合规定的医疗器械案处罚依据医疗器械监督管理条例》第八十八条;违法事实主要违法事实:经查明:慈溪市锦福药店于2024年4月29日采购了5瓶大德门®虱疥一扫光TM喷洒式给药器,该给药器说明书、标签上标有比其他字体更大的“虱疥一扫光TM”字样,且药筒内含有棕色液体,与说明书和标签上的产品描述内容“由药筒(无内容物)、喷头、外盖三部分组成”不一致,让消费者误解该产品具有清除虱疥的功能。行政处罚种类、依据、内容:当事人经营的喷洒式给药器说明书、标签上标有比其他字体更大的“虱疥一扫光TM”字样,且药筒内含有棕色液体,与说明书和标签上的产品描述内容“由药筒(无内容物)、喷头、外盖三部分组成”不一致,让消费者误解该产品具有清除虱疥的功能的行为,违反了《医疗器械说明书和标签管理规定》第十四条第七项的规定,根据《医疗器械监督管理条例》第八十八条第二项的规定,责令当事人立即改正,并对当事人从轻处罚如下:罚款10000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。处罚机关慈溪市市场监督管理局处罚机关统一社会信用代码11330282095537395H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。

行政相对人名称江苏百岁堂大药房连锁有限公司行政相对人类别法人及非法人组织统一社会信用代码913211833546180517工商注册号组织机构代码税务登记号事业单位证书号社会组织登记证号法定代表人王高峰法定代表人证件类型法定代表人证件号码证件类型证件号码行政处罚决定书文号苏药监镇处字【2024】5号违法行为类型《药品管理法》第九十八条第一款违法事实该单位经营的珍珠明目滴眼液（批号24060205）经检验可见异物不符合规定，涉嫌违反了《药品管理法》第九十八条第一款的规定。处罚依据《药品管理法》第一百一十七条第一款、《药品管理法实施条例》第七十五条的规定处罚类别没收违法所得处罚内容没收违法所得3810.96元罚款金额（万元）没收违法所得没收非法财物的金额（万元）0.38暂扣或吊销证照名称及编号处罚决定日期2025/01/21处罚有效期2025/07/21公示截止期2026/01/21处罚机关江苏省药品监督管理局处罚机关统一社会信用代码11320000014000394R数据来源单位江苏省药品监督管理局数据来源单位统一社会信用代码11320000014000394R备注相关推荐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 UPS and Electronic MailReference #:CBER 25-679023Product:DrugsRecipient:Mary Pat Moyer, PhDChief Executive Officer and Chief Science OfficerINCELL Corporation LLC12734 Cimarron PathSan Antonio,TX78249United Stateslynn.miller@incell.comIssuing Office:Center for Biologics Evaluation and Research (CBER)United StatesWARNING LETTERCBER 25-679023Dear Dr. Moyer:The United States Food and Drug Administration (FDA) inspected your facility located at the above address between September 25, 2023, and September 29, 2023. During the inspection, FDA documented that your company manufactures a product derived from amniotic fluid,(b)(4), pursuant to a contract with(b)(4)(hereinafter, “(b)(4)” or “your product”).This letter is to advise you that your product is an unapproved new drug in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 355(a). Your introduction or delivery for introduction of your product into interstate commerce is prohibited under section 301(d) of the FD&C Act, 21 U.S.C. § 331(d). Your product is also an unlicensed biological product in violation of section 351(a)(1) of the Public Health Service Act (PHS Act), 42 U.S.C. § 262(a)(1)(A).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. Because your methods, facilities, or controls for manufacturing, processing, packing, or holding drugs do not conform to CGMP, your product is adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. § 351(a)(2)(B). Furthermore,(b)(4)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(b)(4), an adulterated and misbranded drug, into interstate commerce is a prohibited act under section 301(a) of the FD&C Act, 21 U.S.C. § 331(a). U.S. Food and Drug AdministrationUnapproved New Drug and Unlicensed Biological Product ViolationsBased on information and records gathered prior to, during, and after the inspection and other information available to FDA, including(b)(4)website(b)(4), your product is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease or conditions in humans and/or is intended to affect the structure or function of the body. According to(b)(4)product specification sheet collected from INCELL Corporation LLC during the inspection of INCELL Corporation LLC,(b)(4)is intended for “(b)(4).” As noted above, you manufacture(b)(4)for(b)(4)pursuant to a contract with(b)(4)promotional material obtained from(b)(4)states the following: “(b)(4)”. Further,(b)(4)website indicates that “(b)(4)is a(b)(4)” and describes(b)(4)as “(b)(4).” Your product is therefore a drug as defined in section 201(g)(1) of the FD&C Act, 21 U.S.C. § 321(g)(1). Additionally, your product is a biological product as defined in section 351(i) of the PHS Act, 42 U.S.C. § 262(i).1Subject 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 biologics license application (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 products are safe, pure, and potent. Your product is not the subject of an approved BLA.Current Good Manufacturing Practice ViolationsDuring the inspection, FDA investigators also documented evidence of significant violations of CGMP requirements applicable to your product, including violations of section 501(a)(2)(B) of the FD&C Act and 21 CFR parts 210 and 211. At the conclusion of the inspection, FDA investigators issued a Form FDA-483, List of Inspectional Observations. Your CGMP violations include, but are not limited to, the following:1. Failure to establish and follow appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile, including procedures for validation of all aseptic and sterilization processes [21 CFR211.113(b)].For example, the aseptic processes used to manufacture your product have not been validated (e.g., by performing media fill simulations) since your firm’s manufacturing operations for the subject product began in February 2020. Your product purports to be sterile and is expected to be sterile.We acknowledge your October 18, 2023, response to this violation. It is noted that you have no plans of performing aseptic processing validation for the manufacturing of your product. You assert that you test(b)(4)and other sterile liquid fill products and there have been no sterility failures. You also assert that you monitor customer complaints. This is not suitable justification for the absence of aseptic processing validation. Sterility tests are limited in their ability to detect contamination because of the small sample size typically used. To ensure the sterility of products purporting to be sterile, all aseptic and sterilization processes must be adequately validated in accordance with 21 CFR 211.113(b). Typically, aseptic process validation is performed using a media fill that includes exposing microbiological growth medium to product contact surfaces of equipment, container closure systems, critical environments, and process manipulations to closely simulate where(b)(4)is exposed to the environment during processing.2. Failure to establish 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 [21 CFR211.160(b)].For example, you have not established scientifically sound and appropriate specifications to assure that your product conforms to appropriate standards of identity. Your specification for finished product testing does not include a requirement to perform identity testing.We acknowledge your October 18, 2023, response to this violation. You state that while specific markers have not been routinely included in the(b)(4)release protocol, you have done extensive studies on amniotic fluid and its composition and characterization. You also state, however, that you have not used the results from these studies for routine testing including release and stability testing. Documentation related to proposed release and stability tests using these results have not been provided for review. Further, you have not described any actions to be taken for violative product on the market that remains within the labeled expiry.3. Failure to establish a written testing program designed to assess the stability characteristics of drug products and to use results of such stability testing to determine appropriate storage conditions and expiration dates [21 CFR 211.166(a)].Specifically, your certificate of analysis for your product states that the expiry period is(b)(4), while your instructions for use (IFU) labels your product as having a “(b)(4).” You therefore assigned(b)(4)expiration dates to your product without supporting data regarding the stability characteristics of the product.We acknowledge your October 18, 2023, response to this violation. It is noted that you intend to(b)(4). However, documentation related to these studies has not been provided for review nor have you notified FDA that these studies have been performed. Further, you have not described any actions to be taken for violative product on the market that remains within the unsubstantiated label expiry. A suitable expiration date, supported with data, is needed to ensure product quality over the shelf life of the product.Misbranding ViolationYour 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, the IFU for your product indicates that “(b)(4).” This description implies that your product is provided as(b)(4)when it is actually a(b)(4). Further, as noted above, your certificate of analysis for your product states that the expiry period is(b)(4), while your IFU states that your product has a “(b)(4).” Neither of these statements about the stability of your product are supported with stability data. These false or misleading representations about your product on your labeling cause this product to be misbranded under section 502(a) of the FD&C Act, 21 U.S.C. § 352(a).We acknowledge your October 18, 2023, response to the labeling discrepancies. You state that the errors in the description and expiration date resulted from a miscommunication between the distributor ((b)(4)) and the manufacturer of your product (INCELL Corporation LLC). As indicated above, you state that new stability studies are being conducted and the expiry date will be corrected once these studies are complete. Additionally, you state, “a newly created form addressing these issues will be implemented for a revised contract with(b)(4), and all new contracts should eliminate any miscommunications or misunderstandings”. While the corrective actions for these discrepancies appear acceptable, you have not provided any documentation related to these changes for review. Please provide your revised IFU for review. Further, you have not described any actions to be taken for violative product on the market that contain these errors and are within labeled expiry. The IFU guides the patient or physician on how to safely and effectively use your product and commonly includes instructions on preparation, administration, handling, storage, and disposal. If inaccurate IFU are provided to patients or physicians, the safety and effectiveness of your product may be compromised.Additional ConcernsIt is noted that in 2020, you manufactured(b)(4), which is also a product derived from amniotic fluid. Please clarify if you are currently manufacturing(b)(4)or plan to resume manufacturing it.Further, documents provided during the inspection lack evidence that adequate environmental monitoring takes place in the(b)(4)ISO(b)(4)manufacturing environment where(b)(4)is exposed to the environment during processing. Specifically, results associated with batch records only include passive microorganism monitoring (i.e.,(b)(4)) and non-viable particulate monitoring. There is no mention of viable microorganism monitoring such as(b)(4)sampling and personnel monitoring in association with each batch. Various sampling methods are needed to adequately identify potential routes of contamination.ConclusionNeither this letter nor the observations noted on the Form FDA-483 are intended to be an all-inclusive list of deficiencies that may exist at your facility. It is your responsibility to ensure full compliance with the FD&C Act, PHS Act, and all applicable regulations.This letter notifies you of our findings and provides you an opportunity to address them. Failure to adequately address these matters may result in regulatory action without further notice. Such actions may include seizure and/or injunction.We request that you respond 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 ResearchCc:(b)(4)______________________1FDA does not consider(b)(4), an amniotic fluid-based product, to be a human cell, tissue, or cellular or tissue-based product (HCT/P). HCT/Ps, as defined in 21 CFR 1271.3(d), do not include secreted or extracted human products. Accordingly, secreted bodily fluids, such as amniotic fluid, are generally not considered HCT/Ps subject to regulation under 21 CFR part 1271.

Product:DrugsRecipient:www.weightcrunchshop.comHong Kong SAR ChinaIssuing Office:Center for Drug Evaluation and Research (CDER)United States United StatesTO: www.weightcrunchshop.comFROM: The United States Food and Drug AdministrationRE: Notice of Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the InternetDATE: January 13, 2025WARNING LETTERThis is to advise you that the United States (U.S.) Food and Drug Administration (FDA) recently reviewed your website at the Internet address www.weightcrunchshop.com and has observed that your website introduces into interstate commerce misbranded and unapproved new drugs in violation of sections 301(a), 301(d), 301(k), 503(b), and 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. §§ 331(a), 331(d), 331(k), 353(b), and 355(a)].As discussed below, FDA has observed that www.weightcrunchshop.com introduces into interstate commerce unapproved and misbranded semaglutide and opioid drug products. There are inherent risks to consumers who purchase unapproved new drugs and misbranded drugs. Unapproved new drugs do not carry the same assurances of safety and effectiveness as those drugs subject to FDA oversight. Drugs that have circumvented regulatory safeguards may be contaminated, counterfeit, contain varying amounts of active ingredients, or contain different ingredients altogether. Accordingly, FDA requests that www.weightcrunchshop.com cease offering any unapproved and misbranded drugs for sale to U.S. consumers. This is critical to protect the public from harm.Unapproved New Drugs:Certain products offered for sale by www.weightcrunchshop.com are drugs within the meaning of section 201(g) of the FD&C Act [21 U.S.C. § 321(g)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or because they are intended to affect the structure or function of the body. These drugs are also new drugs as defined by section 201(p) of the FD&C Act [21 U.S.C. § 321(p)], because they are not generally recognized as safe and effective for their labeled uses. With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, 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 are in effect for these products. Accordingly, their introduction or delivery for introduction into interstate commerce violates sections 301(d) [21 U.S.C. § 331(d)] and 505(a) of the FD&C Act.For example, www.weightcrunchshop.com offers semaglutide drug products marketed as “Orsema 0.25 mg” injectable and “Orsema 0.50 mg” injectable. Your website states that the product is intended as, “An adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus,” and “To reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease.” While there are FDA-approved versions of semaglutide on the market in the U.S., there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for “Orsema 0.25 mg” or “Orsema 0.50 mg” offered by www.weightcrunchshop.com. Currently, there are two injectable semaglutide products FDA-approved for the U.S. market and these products are only available pursuant to a prescription from a licensed practitioner. FDA-approved semaglutide injection marketed under the brand name Ozempic is indicated as an adjunct to diet and exercise to improve glycemic control in individuals with type 2 diabetes mellitus and to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease. FDA-approved semaglutide injection marketed under the brand name Wegovy is indicated as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in certain adult and pediatric patients. FDA-approved semaglutide products bear a boxed warning, commonly referred to as a “black box warning,” which is the strongest warning FDA requires, indicating that the drug carries a significant risk of serious or even life-threatening adverse effects. The boxed warning addresses the risk of thyroid C-cell tumors.Misbranded Drugs:A drug is misbranded under section 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)] if its labeling fails to bear adequate directions for use. “Adequate directions for use,” means directions under which a layperson 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. Prescription drugs, as defined in section 503(b)(1)(A) of the FD&C Act, can be used safely only at the direction, and under the supervision, of a licensed practitioner.Because “Orsema 0.25 mg” and “Orsema 0.50 mg” are prescription drugs intended for conditions that are not amenable to self-diagnosis and treatment by a layperson, adequate directions cannot be written such that a layperson can use the products safely for the intended use. Consequently, the labeling for the drugs fails to bear adequate directions for use, causing them to be misbranded under section 502(f)(1) of the FD&C Act. In addition, because the drugs are not approved in the U.S., they are also not exempt under 21 CFR 201.115(a) from the requirements of section 502(f)(1) of the FD&C Act. By offering these drugs for sale to U.S. consumers, www.weightcrunchshop.com is causing the introduction of misbranded drugs into interstate commerce in violation of section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].Additionally, FDA has observed that www.weightcrunchshop.com offers prescription drugs for sale without a prescription. For example, your website offers semaglutide drug products marketed as “Ozempic 0.25 mg,” “Ozempic 0.5 mg,” and “Ozempic 1 mg.” Your website states, “Ozempic is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Buy Ozempic Online without Prescription with Credit Card.” Ozempic is the brand name of an FDA-approved drug for the treatment of type 2 diabetes mellitus and established cardiovascular disease that is only available by prescription. Using the brand name of the drug product Ozempic indicates that this product is intended to treat type 2 diabetes mellitus and established cardiovascular disease. The FDA-approved product Ozempic has been approved for marketing by FDA and is limited by a new drug application to use under the supervision of a practitioner licensed to administer such drugs. Therefore, Ozempic is a prescription drug as defined in section 503(b)(1)(A) of the FD&C Act (21 U.S.C. § 353(b)(1)(A)).Furthermore, www.weightcrunchshop.com offers oxycodone 15 mg and 30 mg tablets described as “moderately potent opioid analgesic, generally indicated for the relief of moderate to severe pain.” Your website, www.weightcrunchshop.com also states that “oxycodone is for sale without a prescription.” FDA-approved oxycodone is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate and is only available pursuant to a prescription from a licensed practitioner. FDA-approved oxycodone products bear a boxed warning that addresses risks including addiction, abuse, misuse, life-threatening respiratory depression (breathing problems), and neonatal opioid withdrawal syndrome (withdrawal symptoms in newborn baby). In addition, when oxycodone is taken in conjunction with other central nervous system depressants, including alcohol and benzodiazepines, use may result in coma or death.Under U.S. law, prescription drugs can be dispensed only pursuant to a prescription from a healthcare practitioner licensed by law to administer prescription drugs. By offering the aforementioned drugs without requiring a prescription, www.weightcrunchshop.com jeopardizes patient safety and misbrands the drugs under section 503(b)(1) of the FD&C Act. Dispensing a prescription drug without a prescription is an act which results in the drug being misbranded while held for sale, in violation of section 301(k) of the FD&C Act [21 U.S.C. § 331(k)].FDA is sending this warning letter to www.weightcrunchshop.com because of the inherent risks to consumers who purchase misbranded and unapproved new drugs. This letter is not intended to identify all the ways in which your products or operations might be in violation of the law. It is your responsibility to ensure that all products you offer for sale are in compliance with the FD&C Act and its implementing regulations. You should take prompt action to address any violations of the FD&C Act (which may include the offer for sale of similarly misbranded and/or unapproved new drugs other than the drugs noted above). We advise you to review your websites, product labels, and other labeling and promotional materials to ensure that you are not misleadingly representing your products as safe and effective for a use for which they have not been approved by FDA and that you are not distributing misbranded products in violation of the FD&C Act.Please notify this office in writing within 15 working days describing the specific steps you have taken to address any violations and to prevent their recurrence. Include an explanation of each step being taken to remedy and prevent the recurrence of any violations, as well as copies of related documentation. Failure to adequately address this matter may result in legal action, including, without limitation, seizure and injunction, without further notice. If you cannot complete corrective action within 15 working days, state the reason for the delay and the time within which you will complete the corrections. This letter notifies you of our concerns and provides you with an opportunity to address them. 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 within 15 working days.If you are not located in the U.S., please note that products that appear to be misbranded or unapproved new drugs may be detained or refused admission. We may advise the appropriate regulatory officials in the country from which you operate that your products referenced above appear to be unapproved and misbranded products that cannot be legally sold to consumers in the U.S.Please direct your response and any inquiries to FDA at FDAInternetPharmacyTaskForce-CDER@fda.hhs.gov.Sincerely,/S/S. Leigh Verbois, Ph.D.Director, Office of Drug Security, Integrity, and ResponseOffice of ComplianceCenter for Drug Evaluation and Research

行政相对人名称：东莞市德爱堂医药有限公司东城牛山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91441900MA56338J2E44***********23法人代表姓名：叶建斌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〕Z320250120C01违法行为类型：《药品流通监督管理办法》第十八条第一款“药品零售企业应当按照国家食品药品监督管理局药品分类管理规定的要求，凭处方销售处方药。”,《药品经营和使用质量监督管理办法》第四十二条第一款“药品零售企业应当遵守国家处方药与非处方药分类管理制度，按规定凭处方销售处方药，处方保留不少于五年。”违法事实：2024年12月6日，我科接到12315举报线索（编号：***************0690767511），反映东莞市德爱堂医药有限公司涉嫌销售未凭处方销售处方药“[宝林可]加味逍遥胶囊”。经调查，东莞市德爱堂医药有限公司接到销售订单后将订单推送给东莞市德爱堂医药有限公司东城牛山分店，由东城牛山分店实际销售“[宝林可]加味逍遥胶囊”，东城牛山分店在销售该药品未凭处方进行销售。东莞市德爱堂医药有限公司东城牛山分店涉嫌未凭处方销售处方药“[宝林可]加味逍遥胶囊”（生产厂家：四川宝兴制药有限公司；批准文号：国药准字Z10960056；批号：240401），上述行为涉嫌违反《药品经营和使用质量监督管理办法》第四十二条第一款“药品零售企业应当遵守国家处方药与非处方药分类管理制度，按规定凭处方销售处方药，处方保留不少于五年。”的规定。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：罚款人民币壹仟元整（1000）。罚款金额（万元）：0.1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：2025-01-20公示截止期：2028-01-20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xxx有限公司行政相对人类别法人及非法人组织行政相对人代码_1(统一社会信用代码)xxx法定代表人xxx行政处罚决定书文号粤药监妆罚〔2025〕3002号违法行为类型未按照化妆品生产质量管理规范的要求组织生产化妆品。违法事实我局于2024年8月14日对照《化妆品生产质量管理规范》《化妆品生产质量管理规范检查要点及判定原则》对当事人开展监督检查，发现当事人存在不符合化妆品生产质量管理规范的项目共11项（其中，关键项目2项、重点项目2项、一般项目7项），依据《化妆品生产质量管理规范检查要点及判定原则》的相关规定，判定当事人生产质量管理体系存在严重缺陷。当事人上述行为，违反了《化妆品监督管理条例》第二十九条第一款的规定。处罚依据《化妆品监督管理条例》第六十条第（三）项的规定。处罚类别没收违法所得，罚款。处罚内容1.没收违法所得9520元;2.罚款30000元。罚款金额（万元）3没收违法所得、没收非法财物的金额（万元）0.9520处罚决定日期2025年1月6日处罚有效期1年处罚机关广东省药品监督管理局处罚机关统一社会信用代码11440000MB2D034421数据来源单位广东省药品监督管理局数据来源单位统一社会信用代码11440000MB2D034421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。