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FDA警告信21/12/14--标签中药品成分与实际不符(中英文)

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标签中药品成分与实际不符,FDA发出警告信。
WARNING LETTER
Guangdong Kemei Pharmaceutical Technology Co. Ltd.
MARCS-CMS 612090 — DECEMBER 14, 2021
Warning Letter 320-22-07
December 14, 2021
Dear Mr. Chen:
Your firm is registered as a human drug manufacturer. The U.S. Food and Drug Administration (FDA) conducted testing of a consumer antiseptic hand rub drug product (also referred to as a consumer hand sanitizer), labeled as IMC WASH-FREE HAND SANITIZER. This drug product was declared to be manufactured at your facility, Guangdong Kemei Pharmaceutical Technology Co. Ltd, FEI 3017086967, at 2,4, No.16 (#6 Plant), Jiye Road 3rd & 4th Floor, Songgang Songxia Industrial Park, Shishan Foshan, China. Following an attempt to import IMC WASH-FREE HAND SANITIZER into the United States, it was detained and refused admission at the border.
贵公司是注册为人用药物生产商。美国食品和药物管理局(FDA)对一种名为“IMC免洗洗手液”的消费者擦洗药品(也称为消费者用洗手液)进行了测试。本药品申报在贵工厂生产,广东科美制药科技有限公司(FEI 3017086967),地址为中国佛山石山市松岗松夏工业园区继业路3、4楼16号(6号厂房)2、4号。在将IMC免洗洗手液进口到美国时,在边境被扣留和拒绝入境。
The results of the FDA laboratory testing of a batch of this product detained at the border demonstrate that this drug product declared to be manufactured at your facility is adulterated within the meaning of section 501(d)(2) of the Federal Food, Drug, and Cosmetic Act (FD&C Act or the Act), 21 U.S.C. 351(d)(2), in that a substance was substituted wholly or in part therefor. In addition, this 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)), in that the substitution demonstrates that the quality assurance within your facility is not functioning in accordance with Current Good Manufacturing Practice (CGMP) requirements.
FDA对一批在边境扣留的产品的实验室测试结果表明,根据《联邦食品、药物和化妆品法案》(FD&C法案或法案)21 U.S.C. 351(d)(2)第501(d)(2)条,申报在贵工厂生产的是药品是掺假药品,因为一种物质被全部或部分替代。此外,根据FD&C法案(21 U.S.C. 351(a)(2)(B))第501(a)(2)(B)条,该产品被定义为掺假,因为该替代产品证明贵工厂的质量保证不符合当前良好生产规范(CGMP)的要求。
In addition, IMC WASH-FREE HAND SANITIZER is an unapproved new drug introduced or delivered for introduction into interstate commerce in violation of section 505(a) of the FD&C Act, 21 U.S.C. 355(a), and is misbranded under sections 502(j), (a), (e), (x) and (ee) of the FD&C Act, 21 U.S.C. 352(j), (a), (e), (x) and (ee). Introduction or delivery for introduction of such products into interstate commerce is prohibited under sections 301(d) and (a) of the FD&C Act, 21 U.S.C. 331(d) and (a). These violations are described in more detail below.
此外,IMC免洗洗手液是一种未经批准的新药,引入或交付到州际商业中,违反了FD&C法案第505(a)条,21 U.S.C. 355(a)条,并违反FD&C法案第502(j), (a), (e), (x)和(ee)条,21 U.S.C. 352(j), (a), (e), (x)和(ee)。根据《FD&C法案》第301(d)和(a)条,21 U.S.C. 331(d)和(a)条,禁止将此类产品引入州际贸易。以下将详细描述这些违规行为。
Adulteration Violations

掺假违法行为

IMC WASH-FREE HAND SANITIZER, declared to be manufactured at your facility, is labeled to contain 75% of the active ingredient ethyl alcohol (ethanol). However, FDA laboratory testing of a batch of this product detained at the border found that the drug product contained an average 35% ethanol volume/volume (v/v) and an average of 32% methanol v/v. Therefore, this hand sanitizer drug product is adulterated under section 501(d)(2) of the FD&C Act in that the active ingredient, ethanol, was substituted wholly or in part with methanol, a dangerous chemical when in contact with human skin or ingested.
声明在贵工厂生产的IMC免洗洗手液,标签上标明含有75%的有效成分酒精(乙醇)。然而,FDA对一批在边境扣留的该产品的实验室检测发现,该药品平均含有35%的乙醇体积/体积(v/v)和32%的甲醇体积/v。因此,根据FD&C法案第501(d)(2)条,该洗手液药品为掺假药品,因为活性成分乙醇被全部或部分用甲醇替代,甲醇在与人体皮肤接触或摄入时是一种危险化学品。
Methanol is not an acceptable ingredient for hand sanitizers and should not be used due to its toxic effects. Skin exposure to methanol can cause dermatitis, as well as transdermal absorption with systemic toxicity. Substantial methanol exposure can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system, or death. Although all persons using these products on their hands are at risk, young children who accidentally ingest these products, and adolescents and adults who drink these products as an alcohol (ethanol) substitute, are most at risk for methanol poisoning.
甲醇不是一种可接受的洗手液成分,由于其毒性作用不应使用。皮肤暴露于甲醇可引起皮炎,以及透皮吸收与全身毒性。大量接触甲醇会导致恶心、呕吐、头痛、视力模糊、永久性失明、癫痫发作、昏迷、对神经系统造成永久性损伤,甚至死亡。虽然所有使用这些产品的人都有甲醇中毒的风险,但意外摄入这些产品的幼儿以及将这些产品作为酒精(乙醇)替代品饮用的青少年和成年人甲醇中毒的风险最大。
On December 15, 2020, FDA notified the public of the methanol contamination of your hand sanitizer drug products at the following webpage: https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-hand-sanitizers-consumers-should-not-use
2020年12月15日,FDA通过以下网页通报了企业的洗手液药品甲醇污染问题:https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-hand-sanitizers-consumers-should-not-use
After several unsuccessful attempts to contact you, FDA contacted your firm’s consignees to discuss marketed action.
在多次尝试联系企业失败后,FDA联系了贵公司的代理商并讨论市场行动。
On December 23, 2020, one of your firm’s consignees, Shane Erickson Inc., recalled one lot of Wash-Free Hand Sanitizer (50ml, 100ml and 300ml size bottles) and one lot of Thrifty White Pharmacy Wash-Free Hand Sanitizer due to potential presence of undeclared methanol (wood alcohol), as noted on the following FDA website: shane-erickson-inc-dba-innovative-marketing-consultants-issues-voluntary-nationwide-recall-wash-free
2020年12月23日,贵公司的代理商之一Shane Erickson Inc.召回了一批免洗洗洗手液(50ml、100ml和300ml大小的瓶子)和一批Thrifty White Pharmacy免洗洗洗手液,原因是可能存在未声明的甲醇(木醇),如下FDA网站所述:Shane - Erickson Inc - dpa - innovationmarketing-consultins - issu-voluntary-nationwide-recall-wash-free
On January 14-15, 2021, FDA received correspondence from your firm stating you were not the manufacturer of IMC brand products and that you had given your “FDA certificates” to this third-party that likely manufactured the contaminated hand sanitizer products.
2021年1月14日至15日,FDA收到了贵公司的信函,声明不是IMC品牌产品的制造商,并将企业的“FDA证书”交给了可能生产受污染洗手液产品的第三方。
On January 25, 2021, FDA held a teleconference with your firm. We recommended you consider removing all of your firm’s hand sanitizer drug products currently in distribution to the U.S. market that were labeled as or declared as manufactured by your firm, Guangdong Kemei Pharmaceutical Technology Co. Ltd. Your firm agreed to support the recall of IMC hand sanitizer products. However, to date, your firm has not committed to recall.
2021年1月25日,FDA与贵公司举行了电话会议。我们建议企业考虑召回目前在美国市场销售的所有标明或声明由贵公司广东科美制药科技有限公司生产的洗手液药品。贵公司同意支持召回IMC洗手液产品。然而,到目前为止,贵公司尚未进行召回。
In response to this letter, provide the following:

针对本函,请提供以下信息:

A detailed investigation into how the drug product described above, which was declared to be manufactured at your facility and which was labeled as containing ethanol, was substituted in part or in whole with methanol.
详细调查上述药物产品是如何被甲醇部分或全部替代的,该药物产品被声明为在贵工厂生产,并被标记为含有乙醇。
A list of all raw materials used to manufacture all of your hand sanitizer drug products, including the suppliers’ names, addresses, and contact information.
一份企业用于生产洗手液药品的所有原材料清单,包括供应商的名称、地址和联系信息。
A list of all batches of any hand sanitizer drug products shipped to the United States by your firm, and a full reconciliation of all material you distributed.
贵公司运至美国的所有洗手液药品批次清单,以及企业分发的所有材料的完整核对表。
Copies of the complete batch records for all batches distributed to the U.S.
分发到美国的所有批次的完整批记录副本
The substitution and contamination with methanol in a drug product declared to be manufactured in your facility demonstrates that the quality assurance within your facility is not functioning in accordance with CGMP requirements under section 501(a)(2)(B) of the FD&C Act.1
在贵工厂生产的药品被甲醇替代或污染表明贵工厂的质量保证不符合FD&C Act.1第501(a)(2)(B)条的CGMP要求
Unapproved New Drug and Misbranding Violations

未经批准的新药和错标

IMC WASH-FREE HAND SANITIZER is a “drug” as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because it is 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), and because it is intended to affect the structure or any function of the body. Specifically, this product is intended for use as a consumer topical antiseptic. Examples of claims observed on the IMC WASH-FREE HAND SANITIZER product label and labeling that 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:
IMC免洗洗手液是由FD&C法案第201(g)(1)(B) (21 U.S.C. 321(g)(1)(B)条定义的“药物”,因为它旨在用于疾病的诊断、治愈、缓解、治疗或预防,和/或根据FD&C法案第201(g)(1)(C) (21 U.S.C. 321(g)(1)(C),因为它旨在影响身体的结构或任何功能。具体来说,本产品用于消费者局部消毒。在IMC免洗洗手液产品标签和提供产品预期用途证据(定义见21 CFR 201.128)的标签上观察到的声明示例包括但不限于以下:
“WASH-FREE HAND SANITIZER… Drug Facts…Purpose…Antiseptic…Use(s) to help reduce bacteria on skin…Directions…Apply a small amount in you palm and rub hands together briskly until dry…”
“免洗洗手液…药物成分…用途…杀菌…用于减少皮肤上的细菌…使用方法…取少量于手心,双手快速搓干…”
This topical antiseptic product is a “new drug” within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because it is not generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended, or suggested in its labeling. New drugs may not be 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), unless they are lawfully marketed under section 505G of the FD&C Act (which is not the case for this product, as further described below) or other exceptions not applicable here. No FDA-approved application pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, is in effect for this drug product, nor are we aware of any adequate and well-controlled clinical studies in the published literature that support a determination that your IMC WASH-FREE HAND SANITIZER drug product is GRASE for use under the conditions suggested, recommended, or prescribed in its labeling. Accordingly, this product is an unapproved new drug marketed in violation of sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C 355(a) and 331(d).
这种外用消毒产品是FD&C法案201(p), 21 U.S.C. 321(p)条所指的“新药”,因为在其标签中规定、推荐或建议的条件下使用,通常不被认为是安全有效的(GRASE)。如21 U.S.C. 355(a) FD&C法案第505(a)条所述,未经FDA事先批准,不得将新药引入或交付用于州际商业,除非它们根据FD&C法案第505G条合法销售(本产品不属于这种情况,如下所述)或此处不适用的其他例外情况。FDA根据FD&C法案第505条(21 U.S.C. 355)批准的申请对该药品无效,我们也不知道在已发表的文献中有任何充分的和良好控制的临床研究支持企业的IMC免洗洗手液药品在其标签中建议、推荐或规定的条件下使用是GRASE的决定。因此,该产品是一种未经批准的新药,违反了FD&C法案第505(a)和301(d)条,21 U.S.C 355(a)和331(d)条。
We note that over-the-counter (OTC) topical antiseptic products had been the subject of rulemaking under the Agency’s OTC Drug Review. In particular, such products were addressed in a tentative final monograph (TFM) entitled “Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products,” Proposed Rule, 59 FR 31402 (June 17, 1994) (1994 TFM), as further amended by “Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record,” Proposed Rule, 81 FR 42912 (June 30, 2016)(Consumer Antiseptic Rubs Proposed Rule). Over the course of these rulemakings, three active ingredients (benzalkonium chloride, ethyl alcohol (ethanol), and isopropyl alcohol) were classified as Category III for use in consumer antiseptic rub products, meaning that additional safety and effectiveness data are needed to support a determination that a drug product containing one of these active ingredients would be GRASE for use as a consumer antiseptic rub.
我们注意到,非处方(OTC)外用消毒产品一直是该机构OTC药品审查规则制定的主题。特别是,这些产品在一个暂定的最终专论(TFM)中被提及,题为“用于非处方人类使用的局部抗菌药物产品;卫生保健防腐剂药品的暂定最终专论,“建议规则,59 FR 31402(1994年6月17日)(1994 TFM),由“消费者消毒剂的安全性和有效性;人用非处方局部抗菌药物产品;暂定最终专著的修订建议;《重新开放行政记录》,《建议规则》81 FR 42912(2016年6月30日)(消费者抗菌擦剂建议规则)。在这些规则制定过程中,三种有效成分(苯甲氯铵、酒精(乙醇)和异丙醇)被归类为III类,用于消费者消毒擦剂产品,这意味着需要额外的安全性和有效性数据来支持确定含有其中一种有效成分的药品将作为消费者消毒擦剂使用。
Section 505G of the FD&C Act addresses nonprescription drugs marketed without an approved application. Under section 505G(a)(3) of the FD&C Act, drugs that were classified as Category III for safety and effectiveness in a TFM that is the most recently applicable proposal or determination for such drug issued under 21 CFR Part 330 – and that were not classified as Category II for safety or effectiveness – are not required to have an approved application under section 505 in order to be marketed, as long as they are in conformity with the relevant conditions of use outlined in the applicable TFM, including the active ingredient, and comply with all other applicable requirements.
《FD&C法案》第505G节涉及未经批准申请销售的非处方药。根据FD&C法案第505G(a)(3)节,在TFM中被分类为安全性和有效性第三类的药物,是根据21 CFR第330部分发布的该类药物的最新适用提案或决定,且未被分类为第二类的安全性或有效性,无需根据第505节获得批准申请才能上市,只要它们符合适用TFM中概述的相关使用条件,包括活性成分,并符合所有其他适用要求。
However, IMC WASH-FREE HAND SANITIZER does not conform to the 1994 TFM, as further amended by the 2016 Consumer Antiseptic Rubs Proposed Rule, nor any other TFM, proposed rule, or final rule, and do not meet the conditions under section 505G(a)(3) of the FD&C Act for marketing without an approved application under section 505.
然而,IMC免洗洗手液不符合1994年TFM(经2016年消费者抗菌搓洗拟议规则进一步修订),也不符合任何其他TFM、拟议规则或最终规则,且不符合FD&C法案第505G(a)(3) 节规定的条件,无需根据第505节批准申请即可上市。
According to the product label, IMC WASH-FREE HAND SANITIZER purportedly contains the active ingredient ethyl alcohol 75% v/v. However, as previously discussed, FDA laboratory analyses of a batch of this product detained at the border demonstrated that IMC WASH-FREE HAND SANITIZER contains ethanol in a concentration that is less than the 75% v/v stated on its product label and less than the amount of ethanol described in the 1994 TFM. Such a product does not conform with the TFM or the applicable requirements, nor is it consistent with the formulations described in the guidance setting forth FDA’s temporary policies for hand sanitizers during the COVID-19 public health emergency.
根据产品标签,IMC免洗洗手液据称含有活性成分75%乙醇。然而,如前所述,美国食品和药物管理局(FDA)对在边境扣留的一批此类产品的实验室分析表明,IMC免洗洗手液中的乙醇浓度低于其产品标签上规定的75%v/v,且低于1994年TFM中规定的乙醇量。此类产品不符合TFM或适用要求,也不符合新冠肺炎公共卫生紧急情况期间FDA洗手液临时政策指南中所述的配方。
FDA laboratory analyses also demonstrated that batches of IMC WASH-FREE HAND SANITIZER contain significant concentrations of the undeclared ingredient methyl alcohol (methanol). Use of methanol as an active ingredient is not in conformance with the 1994 TFM, nor is methanol included in the formulations described in FDA’s Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) Guidance for Industry. Furthermore, methanol is not acceptable as an inactive ingredient in hand sanitizers. As previously discussed, methanol has significant and sometimes fatal toxic effects and, therefore, does not meet the requirements under 21 CFR 330.1(e) that a product’s inactive ingredients be safe and suitable.
FDA实验室分析还表明,一批IMC免洗洗手液含有大量未申报成分甲醇(甲醇)。使用甲醇作为活性成分不符合1994年TFM,也不包括在FDA关于在公共卫生紧急情况(新冠肺炎)行业指南期间制备某些酒精洗手液产品的临时政策中所述的配方中。此外,甲醇不可作为洗手液中的非活性成分。如前所述,甲醇具有显著且有时致命的毒性作用,因此不符合21 CFR 330.1(e)的要求,即产品的非活性成分是安全和合适的。
Additionally, this methanol-containing drug product, IMC WASH-FREE HAND SANITIZER, is misbranded under sections 502(j), (a), (e), (x), and (ee) of the FD&C Act, 21 U.S.C. 352(j), (a), (e), (x), and (ee).
此外,这种含甲醇的IMC免洗洗手液药品,根据FD&C法案21 U.S.C. 352(j), (a), (e), (x)和(ee)第502(j), (a), (e), (x)和(ee)节的规定为错标产品。
It is misbranded under section 502(j) of the FD&C Act, 21 U.S.C. 352(j), because it is dangerous to health when used according to its labeling as a hand sanitizer. As previously stated, skin exposure to methanol could lead to systemic absorption, and substantial methanol exposure can potentially result in, among other things, blindness, permanent nervous system damage, and even death.
根据21 U.S.C. 352(j)《FD&C法案》第502(j)条,它被贴上了错误的标签,因为根据其标签,作为洗手液使用时对健康有害。如前所述,皮肤接触甲醇会导致全身吸收,大量接触甲醇可能导致失明、永久性神经系统损伤,甚至死亡。
This hand sanitizer is misbranded under section 502(a) of the FD&C Act, 21 U.S.C 352(a), because its labeling is false or misleading. As noted above, IMC WASH-FREE HAND SANITIZER is labeled to contain ethyl alcohol 75% v/v. However, FDA laboratory analysis of batches of this product demonstrate that the product contains a concentration of ethyl alcohol (ethanol) that is less than what is stated on the product label and contains a significant concentration of methyl alcohol (methanol), an ingredient that is not declared on the product label. Section 201(n) of the FD&C Act, 21 U.S.C. 321(n), provides that “in determining whether the 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 the light of such representations or material with respect to consequences which may result . . .” Thus, the misleading representation of the concentration of the active ingredient ethyl alcohol (ethanol), and the failure of the product label to disclose the presence of the methyl alcohol (methanol) in the product, causes this product to be misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a).
根据FD&C法案(21 U.S.C 352(a))第502(a)条,这款洗手液为错标产品,因为它的标签为虚假或误导。如上所述,IMC免洗洗手液标签上标明含有75% v/v的乙醇。然而,FDA对该产品批次的实验室分析表明,该产品含有的酒精(乙醇)浓度低于产品标签上所述的浓度,并含有大量的甲醇(甲醇),这是一种没有在产品标签上声明的成分。FD&C法案第201(n)条,21 U.S.C. 321(n)规定,“在确定标签或广告是否具有误导性时,应考虑…不仅仅是提出或建议的陈述……而且还应考虑标签或广告未能根据此类陈述或可能导致的后果揭示重要事实的程度。”对活性成分酒精(乙醇)浓度的误导性陈述,以及产品标签未能披露产品中存在的甲醇(甲醇),根据《食品、药品和化妆品法》第502(a)节,《美国法典》第21卷第352(a)条,该产品定义为错标产品。
The failure of this product to list methyl alcohol (methanol) as an ingredient on its label also causes it to be misbranded under section 502(e)(1)(A) of the FD&C Act, 21 U.S.C 352(e)(1)(A).
该产品未能在其标签上列出甲醇(甲醇)作为一种成分,也会导致其根据《FD&C法案》第502(e)(1)(A)条(21 U.S.C 352(e)(1)(A)条定义为错标产品。
IMC WASH-FREE HAND SANITIZER is also misbranded under section 502(x) of the FD&C Act, 21 U.S.C. 352(x) because the product label fails to disclose a complete domestic address or domestic telephone number through which the responsible person may receive a report of a serious adverse event with such drug.
根据FD&C法案21 U.S.C. 352(x)第502(x)条,IMC免洗洗手液也被定义为错标,因为产品标签没有显示完整的国内地址或国内电话号码,负责人可以通过该地址或电话号码收到该药物的严重不良事件报告。
Lastly, this product is misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee) because IMC WASH-FREE HAND SANITIZER is a nonprescription drug subject to section 505G of the FD&C U.S.C. 355h, but does not comply with the requirements for marketing under that section and is not the subject of an application approved under section 505 of the FD&C Act 21 U.S.C. 355.
最后,该产品是根据FD&C Act 21 U.S.C. 352(ee)第502(ee)条定义的错标产品,因为IMC免洗洗手液是受FD&C U.S.C. 355h第505G条约束的非处方药,但不符合该条款下的营销要求,也不是根据FD&C Act 21 U.S.C. 355第505条批准的申请对象。
The introduction or delivery for introduction of a misbranded drug into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).
根据《FD&C法案》(21 U.S.C. 331(a))第301(a)条的规定,禁止在州际贸易中引入或交付错标药品。
Additionally, we note that under 21 CFR 201.61(a), “[t]he principal display panel of an over-the-counter drug in package form shall bear as one of its principal features a statement of identity of the commodity.” Under section 505G(a)(3) of the FD&C Act and the 1994 TFM, the statement of identity for health-care antiseptic drug products, a category that included consumer antiseptic rub drug products, must contain “the established name of the drug, if any” (59 FR 31442). Currently, there is no established name for consumer antiseptic rub drug products that have the active ingredient ethyl alcohol and are formulated as a gel. However, we recommend that you include the name “alcohol gel” as part of the statement of identity that appears on the principal display panel of the label for IMC WASH-FREE HAND SANITIZER which will allow consumers to make an informed decisions regarding your topical antiseptic.
此外,FDA注意到,根据21 CFR 201.61(a),“包装形式的非处方药的主要显示面板应印有商品身份声明,这是其主要特征之一。”根据《FD&C法案》第505G(a)(3)条和1994年《TFM》,卫生保健用抗菌药物产品(包括消费用抗菌搓揉药物产品的类别)的身份声明必须包含“药物的确定名称,如果有的话”(59 FR 31442)。目前,以乙醇为有效成分并以凝胶形式配制的消费者抗菌擦药产品还没有确定的名称。但是,我们建议企业在IMC免洗洗手液标签的主要显示面板上,将“酒精凝胶”作为身份声明的一部分,这将使消费者对企业的外用消毒剂做出知情的决定。
CGMP Consultant Recommended

CGMP顾问推荐

Based upon the nature of the violations we identified at your firm, we strongly recommend engaging a consultant qualified as set forth in 21 CFR 211.34 to evaluate your operations and to assist your firm in meeting CGMP requirements if your firm intends to resume manufacturing drugs for the U.S. market. We also recommend that the qualified consultant perform a comprehensive audit of your entire operation for CGMP compliance and that the consultant evaluates 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.
基于FDA在贵公司发现的违规行为的性质,我们强烈建议聘请一名符合21 CFR 211.34所述资格的顾问来评估贵司的操作,并在贵公司打算恢复在美国市场生产药品时协助贵公司满足CGMP要求。FDA还建议有资质的顾问对企业的运营情况进行CGMP符合性的全面审计,在解决贵公司对FDA的符合性状况之前,顾问评估企业纠正措施和预防措施的完成情况和有效性。企业使用顾问并不能减轻贵公司遵守CGMP的义务。贵公司的执行管理层仍有责任解决所有缺陷,以确保持续的CGMP符合性。
Conclusion

结论

The violations cited in this letter are not intended to be an all-inclusive list of violations associated with your drug products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. Note that FDA placed all drugs and drug products manufactured by your firm on Import Alert 66-78 on January 7, 2021, as the methods used in and controls used for the manufacture, processing, packing, or holding of these products do not appear to conform to current good manufacturing practices within the meaning of section 501(a)(2)(B) of the FD&C Act. Drugs and drug products that appear to be adulterated may be detained or refused admission without physical examination.
本函中引用的违规行为并非与企业药品相关的所有违规行为。企业有责任调查和确定任何违规行为的原因,并防止其再次发生或发生其他违规行为。请注意,2021 1月7日,美国食品和药物管理局将贵公司生产的所有药品和药物产品列入进口警报66-78,因为这些产品的生产、加工、包装或贮存方法和控制措施似乎不符合《食品和药品法》第501(a)(2)(B)节所指的当前良好生产规范。对有掺假嫌疑的药品和药品产品,可以扣留或者拒绝放行。
All drugs and drug products manufactured by your firm may remain listed on this import alert until there is evidence establishing that the conditions that gave rise to the appearance of the violation have been resolved, and the Agency has confidence that future entries will be in compliance with the FD&C Act. This may include an inspection prior to the Agency considering the appearance of adulteration to be addressed.
贵公司生产的所有药品可能仍列在本进口警报上,直到有证据证明导致出现违规的条件已经解决,并且FDA有信心未来的进口将符合FD&C法案。这可能包括在FDA考虑要处理的掺假外观之前进行检查。
If you decide you want to manufacture drugs for the United States in the future, request a Regulatory Meeting to discuss corrective actions.
如果企业决定将来要为美国生产药品,请召开监管会议讨论纠正措施。
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 do so within 15 working days, state your reasons for delay and your schedule for completion.
本函通知企业FDA的发现,并为企业提供解决上述缺陷的机会。收到此信后,请在15个工作日内书面回复本办公室。说明企业已经采取可什么措施来解决任何违规,并防止其再次发生。在回复这封信时,企业可以提供额外的信息供我们考虑,FDA将继续评估企业的活动和做法。如果企业不能在15个工作日内完成,说明企业的延迟原因和你的完成时间表。
Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov.
Please identify your response with FEI 3017086967 and ATTN: LaKeesha Foster Sifontes.
Sincerely,
/S/
Francis Godwin
Director
Office of Manufacturing Quality
Office of Compliance
Center for Drug Evaluation and Research
cc:
Registered US Agent
Vizocom ICT LLC
860 Jamacha Rd. Ste. 104
El Cajon, CA 92019
________________________________
1 Due to an increased demand for alcohol-based hand sanitizers during the COVID-19 pandemic, FDA published the Guidance for Industry: Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) on March 19, 2020, and subsequently updated the guidance several times, most recently on February 10, 2021. This guidance communicates the Agency’s temporary policy that we do not intend to take action against firms for CGMP violations under section 501(a)(2)(B) of the FD&C Act if such firms prepare alcohol-based hand sanitizers for consumer use (or for use as a health care personnel hand rub) during the public health emergency, provided certain circumstances described in the guidance are present. These circumstances include preparation of hand sanitizer products using only the ingredients and formulas set forth in the guidance. In addition to the violative sample results detailed above that demonstrate the substitution of hand sanitizer products manufactured at your facility, a review of the purported formulations on the drug product’s labeling further indicates that this product is not prepared consistent with FDA’s temporary policy set forth in the guidance. Therefore, this product does not fall within the Agency’s temporary policy not to take action against firms manufacturing hand sanitizer products for violations of section 501(a)(2)(B) of the FD&C Act.
1.由于COVID-19大流行期间对酒精基洗手液的需求增加,FDA于2020年3月19日发布了《行业指南:公共卫生紧急情况(COVID-19)期间制备某些酒精洗手液产品的临时政策》,并随后多次更新该指南,最近一次是在2021年2月10日。本指南传达了FDA的临时政策,如果公司准备了酒精洗手液供消费者在公共卫生紧急情况下使用(或用作医护人员的洗手液),我们不打算对违反FD&C法案第501(a)(2)(B)条的CGMP的公司采取行动,前提是存在指南中描述的特定情况。这些情况包括仅使用指南中规定的成分和配方制备洗手液产品。除了上述证明贵工厂生产的洗手液产品存在替代的违规样品结果外,对药品标签上的所谓配方的审查进一步表明,该产品的制备不符合FDA在该指南中规定的临时政策。因此,本产品不属于FDA对违反FD&C法案第501(a)(2)(B)条生产洗手液产品的公司不采取行动的临时政策。
发布于 2022-09-07 07:53:52 © 著作权归作者所有
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