序号行政处罚决定书文号案件名称违法企业名称或违法自然人姓名违法企业组织机构代码法定代表人姓名主要违法事实行政处罚的种类和依据行政处罚的履行方式和期限做出处罚的机关名称和日期备注1桂药监化稽罚〔2025〕1号桂林市苗氏生物科技有限责任公司生产销售不合格苗舒颜MIAOSHUYAN美肌精华液（批号：2024-03-071）案桂林市苗氏生物科技有限责任公司91450305MA7BTXLQ47蔡玉琼桂林市苗氏生物科技有限责任公司生产销售不合格苗舒颜MIAOSHUYAN美肌精华液（批号：2024-03-071）违反了《化妆品监督管理条例》第六十条第（二）项的规定。桂林市苗氏生物科技有限责任公司生产销售不合格苗舒颜MIAOSHUYAN美肌精华液（批号：2024-03-071），违反了《化妆品监督管理条例》第六十条第（二）项的规定，依据《中华人民共和国行政处罚法》第二十八条第一款，责令当事人立即改正上述违法行为，依据《中华人民共和国行政处罚法》第三十二条第一款第（一）项、《化妆品监督管理条例》第六十条第二项的规定给予当事人以下行政处罚：主动履行广西壮族自治区药品监督管理局2025年6月6日1、没收违法所得贰仟肆佰叁拾贰圆（￥2432.00）；2025年6月27日2、处罚款壹万陆仟圆整（￥11000.00）。以上罚没款共计壹万贰仟肆佰叁拾贰圆（￥13432.00）。

案例一：　　郑州市某药品零售药店未经许可擅自变更经营方式销售药品案　　一、案情简介　　2025年5月，郑州市管城回族区市场监督管理局收到案件线索移送函，称外区某零售药店从管城回族区某零售药店购进了门冬胰岛素注射液6支，并附有该零售药店销售单。　　经执法人员初步调查，该零售药店确向外区零售药店调配了上述6支门冬胰岛素注射液，货值金额209.04元。该零售药店有营业执照和药品经营许可证，其经营方式为零售。调查期间，该零售药店提供了上述药品的购进票据，承认了上述胰岛素注射液是由该店调配，并说明两家门店实际控制人为同一人。该零售药店上述行为违反了《药品经营和使用质量监督管理办法》第三十一条：“从事药品经营活动的，应当遵守药品经营质量管理规范，按照药品经营许可证载明的经营方式和经营范围，在药品监督管理部门核准的地址销售、储存药品，保证药品经营全过程符合法定要求。”依据《药品经营和使用质量监督管理办法》第六十八条“药品经营企业未经批准变更许可事项或者药品经营许可证超过有效期继续开展药品经营活动的，药品监督管理部门按照《中华人民共和国药品管理法》第一百一十五条的规定给予处罚，但是，有下列情形之一，药品经营企业及时改正，不影响药品质量安全的，给予减轻处罚：（一）药品经营企业超出许可的经营方式、经营地址从事药品经营活动的”；《中华人民共和国药品管理法》第一百一十五条“未取得药品生产许可证、药品经营许可证或者医疗机构制剂许可证生产、销售药品的，责令关闭，没收违法生产、销售的药品和违法所得，并处违法生产、销售的药品（包括已售出和未售出的药品，下同）货值金额十五倍以上三十倍以下的罚款；货值金额不足十万元的，按十万元计算。”　　二、法律适用　　《药品经营和使用质量监督管理办法》附则第七十七条对药品零售和药品批发做了固定和解释：“药品批发企业，是指将购进的药品销售给药品生产企业、药品经营企业、医疗机构的药品经营企业。药品零售企业，是指将购进的药品直接销售给消费者的药品经营企业。”　　从本案来看，外区零售药店和该零售药店经营方式都属于药品零售，其只能向消费者销售药品，不能向其他药品经营企业销售药品，该行为属于擅自变更经营方式。　　三、案件处置　　从案情分析来看，该零售药店因对方药店为实控人的另一门店，对质量安全处于同一立场，且属于首次违法，违法行为轻微，能提供上述药品的合法购进票据且积极进行整改，适用于减轻行政处罚。2025年6月，郑州市管城回族区市场监督管理局依据《药品经营和使用质量监督管理办法》和《中华人民共和国药品管理法》对该零售药店立案调查，拟做出以下行政处罚：罚款75000元。　　四、工作启示　　监管部门向当事企业做了法律法规科普，对于同一实际控制人开办的不同药品零售企业，不能相互调配药品，如有此种需求，可以开办药品零售连锁企业，由总部向各门店集中配送，避免出现违法情况。案例二：　　安阳市某零售药店执业药师不在岗销售处方药案　　一、案情概述　　2025年4月，安阳市龙安区市场监督管理局执法人员对辖区内某零售药店进行检查时发现执业药师不在岗，从前台电脑的药品销售系统中调取当天销售记录，发现销售处方药银丹心脑通软胶囊、金匮肾气丸、氧氟沙星滴耳液、去痛片、瑞舒伐他汀钙片、硝苯地平缓释片、单硝酸异山梨酯片，且现场未见对应的处方；执法人员现场书写了现场笔录，并将电脑上的销售记录拍照取证。鉴于2024年12月17日对当事人下达过责令改正通知书，责令其改正执业药师不在岗销售处方药、未按规定凭处方销售处方药的违法行为，此次属于再次违法，应当依法给予行政处罚。　　二、查办结果　　当事人的行为违反了《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。”和第五款：“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。”的规定，构成药品零售企业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行为，药品零售企业未按规定凭处方销售处方药的行为。　　因当事人积极配合调查，并主动提供证据材料，符合《药品监督管理行政处罚裁量适用规则》第十一条第二项：“当事人有下列情形之一的，可以从轻或者减轻行政处罚：（二）积极配合药品监督管理部门调查并主动提供证据材料的；”的规定，当事人裁量等级为从轻。依据《药品经营和使用质量监督管理办法》第七十二条第一项和第三项：“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：“（一）未按规定凭处方销售处方药的；（三）违反本办法第四十二条第五款规定的药师或者药学技术人员管理要求的。”的规定，参照《河南省药品、医疗器械、化妆品行政处罚裁量基准》16.4依据《药品经营和使用质量监督管理办法》第七十二条实施的行政处罚，裁量等级为从轻的裁量基准：“由药品监督管理部门责令限期改正；逾期不改正的，处5000元以上1.85万元以下罚款；造成危害后果的，处5万元以上9.5万元以下罚款。”的规定，决定对当事人处罚款5000元的行政处罚。　　三、工作启示　　（一）重视执业药师的关键作用　　执业药师是药品零售企业保障公众用药安全的重要“守门人”，其职责包括审核处方、指导用药等。一旦执业药师缺位，可能导致患者用药不当，甚至引发严重健康问题。因此，药店必须确保执业药师在职在岗，并严格履行其职责。　　（二）强化企业合规意识　　药品零售企业需严格遵守相关法律法规规章，如《药品经营和使用质量监督管理办法》。该办法明确规定，执业药师不在岗时，其他人员不得销售处方药，并挂牌告知。然而，部分企业在利益驱动下忽视这些要求，出现违规销售处方药的行为，最终面临严厉处罚。企业必须增强合规意识，将法律责任放在首位，确保公众用药安全。　　（三）提升监管力度与精准性　　此类案件凸显出加强药品零售环节监管的重要性。监管部门需加大检查力度，通过突击检查、飞行检查等方式，确保企业严格执行相关法律法规规定。

飞利浦医疗（苏州）有限公司报告，由于系统软件和X射线高压发生器固件之间内部通信的软件问题，可能会导致成像（X射线）功能暂时丧失的情况，飞利浦医疗（苏州）有限公司对其生产的医用血管造影X射线系统主动召回。召回级别为二级。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》

行政相对人名称*****公司行政相对人类别法人及非法人组织行政相对人代码_1(统一社会信用代码)***************法定代表人***行政处罚决定书文号粤药监药罚〔2025〕3002号违法行为类型（一）未从药品上市许可持有人或者具有药品生产、经营资格的企业购进药品；（二）在药品经营活动中未遵守药品经营质量管理规范；（三）在超出许可的经营地址从事药品经营活动。违法事实（一）当事人从无药品经营资质的个人处购进药品并通过等第三方平台网店进行销售，货值金额231237.10元，违法所得231237.10元；（二）在2024年2月29日至3月1日对当事人开展的药品经营监督检查中，发现当事人存在严重缺陷6项，主要缺陷6项，一般缺陷3项；（三）在没有得到许可部门许可的情况下，当事人在惠州市惠城区三栋镇陶前村陶银小区 E1、E2号存放药品。处罚依据《药品管理法》第一百一十五、一百二十六、一百二十九条；《药品经营和使用质量监督管理办法》第六十八条处罚类别吊销许可证；没收非法财物处罚内容吊销《药品经营许可证》；没收违法经营的药品罚款金额（万元）0没收违法所得、没收非法财物的金额（万元）3.5958暂扣或吊销证照名称及编号药品经营许可证（许可证编号：BA7690758）处罚决定日期2025年6月6日处罚有效期36个月处罚机关广东省药品监督管理局处罚机关统一社会信用代码11440000MB2D034421数据来源单位广东省药品监督管理局数据来源单位统一社会信用代码11440000MB2D034421相关推荐：R-1-M-FI-002-01 委托生产费用结算-MAH体系文件模板D-PM-002-01 生产管理岗位职责-MAH体系文件模板D-PM-001-01 生产管理部工作职责-MAH体系文件模板

行政相对人名称*****公司行政相对人类别法人及非法人组织行政相对人代码_1(统一社会信用代码)***************法定代表人***行政处罚决定书文号粤药监药罚〔2025〕3003号违法行为类型（一）未从药品上市许可持有人或者具有药品生产、经营资格的企业购进药品；（二）在超出许可的经营地址从事药品经营活动。违法事实（一）当事人从无药品经营资质的个人处购进药品并通过第三方平台网店进行销售，货值金额3626元，违法所得3626元；（二）在没有得到许可部门许可的情况下，当事人在惠州市惠城区三栋镇陶前村陶银小区 E1、E2号存放药品。处罚依据《药品管理法》第一百一十五、一百二十九条；《药品经营和使用质量监督管理办法》第六十八条处罚类别吊销许可证；没收非法财物处罚内容吊销《药品经营许可证》；没收违法经营的药品罚款金额（万元）0没收违法所得、没收非法财物的金额（万元）0.94623暂扣或吊销证照名称及编号药品经营许可证（许可证编号：BA7690733）处罚决定日期2025年6月6日处罚有效期36个月处罚机关广东省药品监督管理局处罚机关统一社会信用代码11440000MB2D034421数据来源单位广东省药品监督管理局数据来源单位统一社会信用代码11440000MB2D034421相关推荐：R-1-M-FI-002-01 委托生产费用结算-MAH体系文件模板D-PM-002-01 生产管理岗位职责-MAH体系文件模板D-PM-001-01 生产管理部工作职责-MAH体系文件模板

行政相对人名称*****公司行政相对人类别法人及非法人组织行政相对人代码_1(统一社会信用代码)***************法定代表人***行政处罚决定书文号粤药监药罚〔2025〕3002号违法行为类型（一）未从药品上市许可持有人或者具有药品生产、经营资格的企业购进药品；（二）在药品经营活动中未遵守药品经营质量管理规范；（三）在超出许可的经营地址从事药品经营活动。违法事实（一）当事人从无药品经营资质的个人处购进药品并通过等第三方平台网店进行销售，货值金额231237.10元，违法所得231237.10元；（二）在2024年2月29日至3月1日对当事人开展的药品经营监督检查中，发现当事人存在严重缺陷6项，主要缺陷6项，一般缺陷3项；（三）在没有得到许可部门许可的情况下，当事人在惠州市惠城区三栋镇陶前村陶银小区 E1、E2号存放药品。处罚依据《药品管理法》第一百一十五、一百二十六、一百二十九条；《药品经营和使用质量监督管理办法》第六十八条处罚类别吊销许可证；没收非法财物处罚内容吊销《药品经营许可证》；没收违法经营的药品罚款金额（万元）0没收违法所得、没收非法财物的金额（万元）3.5958暂扣或吊销证照名称及编号药品经营许可证（许可证编号：BA7690758）处罚决定日期2025年6月6日处罚有效期36个月处罚机关广东省药品监督管理局处罚机关统一社会信用代码11440000MB2D034421数据来源单位广东省药品监督管理局数据来源单位统一社会信用代码11440000MB2D034421

行政相对人名称*****公司行政相对人类别法人及非法人组织行政相对人代码_1(统一社会信用代码)***************法定代表人***行政处罚决定书文号粤药监药罚〔2025〕3003号违法行为类型（一）未从药品上市许可持有人或者具有药品生产、经营资格的企业购进药品；（二）在超出许可的经营地址从事药品经营活动。违法事实（一）当事人从无药品经营资质的个人处购进药品并通过第三方平台网店进行销售，货值金额3626元，违法所得3626元；（二）在没有得到许可部门许可的情况下，当事人在惠州市惠城区三栋镇陶前村陶银小区 E1、E2号存放药品。处罚依据《药品管理法》第一百一十五、一百二十九条；《药品经营和使用质量监督管理办法》第六十八条处罚类别吊销许可证；没收非法财物处罚内容吊销《药品经营许可证》；没收违法经营的药品罚款金额（万元）0没收违法所得、没收非法财物的金额（万元）0.94623暂扣或吊销证照名称及编号药品经营许可证（许可证编号：BA7690733）处罚决定日期2025年6月6日处罚有效期36个月处罚机关广东省药品监督管理局处罚机关统一社会信用代码11440000MB2D034421数据来源单位广东省药品监督管理局数据来源单位统一社会信用代码11440000MB2D034421

Product:DrugsRecipient:www.bigpharmausa.comUnited StatesIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesTO: www.bigpharmausa.comFROM: The United States Food and Drug AdministrationRE: Notice of Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the InternetDATE: June 4, 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.bigpharmausa.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.bigpharmausa.com introduces into interstate commerce unapproved and misbranded opioid drug products. Opioid addiction and abuse have created an immense public health crisis, and the death toll is staggering. Given the severity of the opioid epidemic, the easy availability of opioids via the Internet poses significant risks to U.S. consumers.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.bigpharmausa.com cease offering any unapproved and misbranded drugs for sale to U.S. consumers. This is critical to shielding the American public from harm.Unapproved New Drugs:Evidence obtained from your website establishes that certain products offered for sale by www.bigpharmausa.com are drugs intended for human use. Examples of claims that provide evidence of the intended use (as defined in 21 CFR 201.128) of these products as drugs for human use include the following:Your description of tramadol marketed as “Generic Tramadol 200 mg,” “Tramadol 200 mg Tabletas,” and “Tramadol 200 mg drug (L011 Pill)” includes:“This medication is approved by the Food and Drug Administration (FDA) for managing moderate to severe pain mainly in adults.”“Tramadol 200 mg medicine acts in the brain and spinal cord (Central Nervous System, CNS) to treat pain.”Your description of oxycodone marketed as “Generic Oxycodone 20 mg” and “Oxycodone 20 mg (M 20 Pill)” includes:“Oxycodone 20 mg (M 20 Pill) is a strong opioid medication that can be used for treating mild to severe pain.”“M 20 pill round [sic] acts by blocking the transmission of pain signals to the brain.”These products 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.bigpharmausa.com offers tramadol marketed as “Generic Tramadol 200 mg,” “Tramadol 200 mg Tabletas,” and “Tramadol 200 mg drug (L011 Pill).” While there are FDA-approved versions of tramadol 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 the “Generic Tramadol 200 mg,” “Tramadol 200 mg Tabletas,” and “Tramadol 200 mg drug (L011 Pill)” offered by www.bigpharmausa.com. FDA-approved tramadol is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. It is only available pursuant to a prescription from a licensed practitioner. FDA-approved tramadol bears 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.As another example, www.bigpharmausa.com offers oxycodone marketed “Generic Oxycodone 20 mg” and “Oxycodone 20 mg (M 20 Pill).” While there are FDA-approved versions of oxycodone 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 “Generic Oxycodone 20 mg” and “Oxycodone 20 mg (M 20 Pill)” offered by www.bigpharmausa.com. FDA-approved oxycodone is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. It is only available pursuant to a prescription from a licensed practitioner. FDA-approved oxycodone also bears a boxed warning indicating that the drug carries a significant risk of serious or even life-threatening adverse effects. The boxed warnings for tramadol and oxycodone address risks including addiction, abuse, misuse, life-threatening respiratory depression (breathing problems), and neonatal opioid withdrawal syndrome (withdrawal symptoms in newborn baby). In addition, when tramadol or oxycodone is taken in conjunction with other central nervous system depressants, including alcohol and benzodiazepines, use may result in coma or death.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 the aforementioned drugs 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 product safely for the intended use. Consequently, the labeling for these drugs fail to bear adequate directions for use, causing them to be misbranded under section 502(f)(1) of the FD&C Act. In addition, because these 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.bigpharmausa.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.bigpharmausa.com offers prescription drugs for sale without a prescription. 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.bigpharmausa.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.bigpharmausa.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/Sangeeta Vaswani Chatterjee, Pharm.D.Acting Director, Office of Drug Security, Integrity, and ResponseOffice of ComplianceCenter for Drug Evaluation and Research

Delivery Method:Via EmailReference #:320-25-79Product:DrugsRecipient:Mr. Sean M. KennyPresidentHorizon Tool Inc.7918 Industrial Village RoadGreensboro,NC27409United StatesIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter320-25-79June 6, 2025Dear Mr. Kenny:The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Horizon Tool Inc., FEI 3016555297, at 7918 Industrial Village Rd, Greensboro, from January 14 to 16, 2025.This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 211).Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug product is adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).We reviewed your February 6, 2025 response to our Form FDA 483 in detail.During our inspection, our investigators observed specific violations including, but not limited to, the following.1. Your firm failed to conduct, for each batch of drug product, appropriate laboratory testing, as necessary, required to be free of objectionable microorganisms (21 CFR 211.165(b)).You manufacture over-the-counter (OTC) drug products, such as antibacterial soaps. You failed to perform microbiological testing for your AllShield E2 Sanitizing Hand Soap. Batch records for lot 25009 indicated you did not take the required sample for microbiological testing, and quality assurance was unable to explain why the sample was not collected or the testing performed. Without testing each batch prior to release, you do not have scientific evidence that all drug product batches conform to the appropriate microbiological standards and are suitable for release to consumers.In your response, you acknowledge that you lacked established product specifications, including microbiological limits, for your AllShield E2 Sanitizing Hand Soap. You identify the root cause as “lack of product development and not following federal regulations.” You also commit to completing product development activities and approving specifications prior to full-scale manufacturing of your AllShield E2 Sanitizing Hand Soap.Your response is inadequate. You do not provide sufficient details and supporting documentation describing how you will ensure AllShield E2 Sanitizing Hand Soap meets appropriate microbiological standards prior to release. Additionally, you do not provide a retrospective risk assessment for the distributed batches.In response to this letter, provide:A list of chemical and microbial test methods and specifications used to analyze each lot of your drug products before making a lot disposition decision, and the associated written procedures.A comprehensive independent assessment of your laboratory practices, procedures, methods, equipment, documentation, and analyst competencies. Based on this review, provide a detailed plan to remediate and evaluate the effectiveness of your laboratory system.2. Your firm failed to establish and follow a written testing program designed to assess the stability characteristics of drug products (21 CFR 211.166(a)).You informed investigators during the inspection, that you lacked a stability testing program for your AllShield E2 Sanitizing Hand Soap. Without appropriate stability studies, you do not have scientific evidence to support whether your drug products meet established specifications and retain their quality attributes throughout the use period.Your response acknowledges that you did not perform stability testing for your AllShield E2 Sanitizing Hand Soap and commits to creating a product development plan that includes stability testing.Your response is inadequate because it lacks sufficient detail and does not provide a retrospective risk assessment for your AllShield E2 Sanitizing Hand Soap released without stability testing.In response to this letter, provide:A comprehensive, independent assessment and corrective action and preventive action plan to ensure the adequacy of your stability program. Your remediated program should include, but not be limited to:o Stability indicating methods.o Stability studies for each drug product in its marketed container-closure system before distribution is permitted.o An ongoing program in which representative batches of each product are added each year to the program to determine if the shelf-life claim remains valid.o Detailed definition of the specific attributes to be tested at each station (timepoint).All procedures that describe these and other elements of your remediated stability program.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 perform adequate identity testing on your incoming components, including active ingredients, before using them in manufacturing your AllShield E2 Sanitizing Hand Soap. Additionally, you failed to ensure that microbiological testing was performed on your benzalkonium chloride solution API, which is required by the United States Pharmacopeia (USP) monograph. Without adequate testing, you do not have scientific evidence that the components conform to appropriate specifications prior to use in the manufacture of your drug products.In your response, you acknowledge that your raw materials procedure “is not robust enough to support raw material testing for drug products.” You plan to revise your raw materials procedure, create testing methods, and train your employees.Your response is inadequate. You fail to provide sufficient details regarding how you will ensure that at least one identity test for each lot of incoming raw materials is performed.In response to this letter, provide:A comprehensive independent review of your material system to determine whether all suppliers of components, containers, and closures, are each qualified and the materials are assigned appropriate expiration or retest dates. The review should also determine whether incoming material controls are adequate to prevent use of unsuitable components, containers, and closures.The chemical and microbiological quality control specifications you use to test and release each incoming lot of components for use in manufacturing.A description of how you will test each component lot for conformity with all appropriate specifications for identity, strength, quality, and purity. If you intend to accept any results from your supplier’s certificate of analysis (COA) instead of testing each component lot for strength, quality, and purity, specify how you will robustly establish the reliability of your supplier’s results through initial validation as well as periodic re-validation. In addition, include a commitment to always conduct at least one specific identity test for each incoming component lot.A summary of results obtained from testing all components to evaluate the reliability of the COA from each component manufacturer. Include your standard operating procedure that describes this COA validation program.A summary of your program for qualifying and overseeing contract facilities that test the components you use to manufacture drug products.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.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 3016555297 and ATTN: Renee A. Marcsisin.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and Research