原辅料检验、召回批次和水系统不符合cGMP要求，FDA发出警告信。
WARNING LETTER
Gordon Laboratories Inc.
MARCS-CMS 631432 — AUGUST 17, 2022
August 17, 2022
Dear Ms. Christiansen:
Your facility is registered with the U.S. Food and Drug Administration as a manufacturer of over-the-counter (OTC) drug products, including consumer antiseptic hand rub drug products (also referred to as consumer hand sanitizers). The FDA conducted testing of a consumer hand sanitizer drug product, labeled as artnaturals SCENT FREE HAND SANITIZER. This drug product was manufactured at your drug manufacturing facility, Gordon Laboratories Inc., FEI 2012546, at 751 E Artesia Blvd., Carson, California, and distributed in the United States.
贵工厂已在美国食品和药物管理局注册为非处方(OTC)药品生产商，包括消费者抗菌洗手液药品(也称为消费者洗手液)。美国食品和药物管理局对一种名为SCENT FREE洗手液的消费者洗手液药物产品进行了测试。该药品是在企业的药品生产工厂(Gordon Laboratories Inc.， FEI 2012546，位于751 E Artesia Blvd Carson, California)生产的，并在美国销售。
The results of the FDA laboratory testing of batches of artnaturals SCENT FREE HAND SANITIZER in U.S. distribution demonstrate that this drug product manufactured at your facility is adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic (FD&C Act), 21 U.S.C. 351(a)(2)(B)1.
FDA对美国销售的SCENT FREE洗手液的实验室检验结果表明，根据《联邦食品、药品和化妆品(FD&C法案)》第501(a)(2)(B)条，21 U.S.C. 351(a)(2)(B)1，贵工厂生产的药品被定义为掺假。
Additionally, the FDA inspected your drug manufacturing facility, Gordon Laboratories, Inc., FEI 2012546, at 751 E Artesia Blvd., Carson, California, from February 8 to March 10, 2022. This inspection followed the violative sample results of the consumer hand sanitizer, labeled as artnaturals SCENT FREE HAND SANITIZER.
此外，2022年2月8日至3月10日，FDA检查了企业位于751 E Artesia Blvd，加利福尼亚州卡森市的药品生产工厂，Gordon Laboratories, Inc, FEI 2012546。这次检查是在消费者洗手液的违规样本结果之后进行的，该洗手液被标记为天然的SCENT FREE洗手液。
This warning letter summarizes significant violations of CGMP regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 211).
本警告信总结了成品药严重违反CGMP规定的情况。参见《联邦法规法典》第21篇，第210和211部分(21 CFR第210和211部分)。
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 FD&C Act, 21 U.S.C. 351(a)(2)(B).
由于生产、加工、包装或贮存方法、设施或控制不符合CGMP，企业的药品在FD&C Act 21 U.S.C. 351(a)(2)(B)第501(a)(2)(B)条中属于掺假药品。
FDA Tested Samples
FDA检测样品
Your firm is a contract manufacturer of artnaturals SCENT FREE HAND SANITIZER.
贵公司是artnaturals洗手液的合同制造商。
FDA laboratory testing of a batch of artnaturals SCENT FREE HAND SANITIZER in U.S. distribution was found to contain impurities at unacceptable levels1. Benzene impurity levels were found to be approximately 15 parts per million (ppm), while acetaldehyde and acetal impurities were found to be approximately 146 ppm and 469 ppm, respectively.
FDA对一批在美国销售的天然香精免洗洗手液的实验室检测发现杂质含量不合格。发现苯杂质水平约为百万分之十五(ppm)，而乙醛和缩醛杂质分别约为百万分之146和百万分之469ppm。
Acetaldehyde appears to be genotoxic, and potentially carcinogenic, when in direct contact with tissues. The FDA has alerted all drug manufacturers to the known risk factors for contamination with benzene. For more information see https://www.fda.gov/drugs/pharmaceutical-quality-resources/fda-alerts-drug-manufacturers-risk-benzene-contamination-certain-drugs.
乙醛与组织直接接触时，似乎具有遗传毒性和潜在的致癌性。FDA已经提醒所有药品制造商注意苯污染的已知风险因素。要了解更多信息，请参见https://www.fda.gov/drugs/pharmaceutical-quality-resources/fda-alerts-drug-manufacturers-risk-benzene-contamination-certain-drugs。
On October 4, 2021, the FDA notified the public of the unacceptable impurity results for artnaturals SCENT FREE HAND SANITIZER at the following website: https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-hand-sanitizers-consumers-should-not-use
2021年10月4日，FDA在以下网站上通知公众 artnaturals洗手液的不可接受的杂质结果:https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-hand-sanitizers-consumers-should-not-use
On October 8, 2021, the FDA held a teleconference with you, and your customer, Virgin Scent Inc. (dba Artnaturals), to whom your firm acts as a contract manufacturer for artnaturals SCENT FREE HAND SANITIZER, and we recommended to consider removing the adulterated batch of artnaturals SCENT FREE HAND SANITIZER drug product currently in distribution from the U.S. market.
2021年10月8日，FDA与企业、客户Virgin Scent Inc. (dba Artnaturals)举行了电话会议，贵公司是该企业的天然香精免洗手液的合同制造商，我们建议考虑从美国市场上召回当前流通的掺假批次的天然香精免洗手液药品。
On October 26, 2021, you, and Virgin Scent Inc., issued a voluntary nationwide recall of two batches of artnaturals SCENT FREE HAND SANITIZER due to the presence of benzene, acetaldehyde, and acetal impurities. On April 22, 2022, the scope of the recall of artnaturals SCENT FREE HAND SANITIZER was expanded to include at least 38 additional batches because they were manufactured using some of the same ingredients as the two batches initially recalled. Refer to the following FDA website:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/artnaturalsr-issues-voluntary-recall-limited-batches-8oz-bottles-scent-free-hand-sanitizer-due
2021年10月26日，企业和Virgin Scent Inc.在全国范围内自愿召回两批含有苯、乙醛和缩醛杂质的天然香精免洗手液。2022年4月22日，人工合成SCENT免洗洗手液的召回范围扩大到至少38个批次，因为它们使用了与最初召回的两个批次相同的一些成分。请参考以下FDA网站:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/artnaturalsr-issues-voluntary-recall-limited-batches-8oz-bottles-scent-free-hand-sanitizer-due
The contamination with benzene, acetaldehyde, and acetal impurities in a drug product manufactured in your facility, in addition to the significant violations documented in the inspection, demonstrate 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 Act1.
贵工厂生产的一种药品中含有苯、乙醛和缩醛杂质的污染，以及在检查中记录的重大违规行为，证明贵工厂的质量保证不符合FD&C Act1第501(a)(2)(B)条的CGMP要求。
CGMP Violations
CGMP违规
We reviewed your March 31, 2022, response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence. Your response is inadequate because it did not provide sufficient detail or evidence of corrective actions to bring your operations into compliance with CGMP.
我们详细审查了企业2022年3月31日对我们FDA 483表格的回复，并确认收到了企业随后的回信。企业的回复是不充分的，因为它没有提供足够的细节或证据来证明企业的操作符合CGMP。
During our inspection, our investigators observed specific violations including, but not limited to, the following.
在我们的检查过程中，我们的调查人员发现了具体的违规行为，包括但不限于以下几点。
1. Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192).
1. 企业未能彻底调查批产品或其成分与质量标准的不明原因的差异或不符，不管这批是否放行销售(21 CFR 211.192)。
Hand Sanitizer Drug Product
洗手液药品
You failed to adequately investigate the root cause of the benzene, acetal, and acetaldehyde impurities found in the artnaturals SCENT FREE HAND SANITIZER drug product.
企业未能充分调查artnaturals SCENT FREE洗手液药品中发现苯、缩醛和乙醛杂质的根本原因。
During the inspection, the investigators found that there was a lack of investigation into the failure of the batches that were voluntarily recalled. Furthermore, you failed to identify whether other batches were impacted or initiate testing of the retain samples of other batches that are in U.S. distribution.
在检查过程中，调查人员发现，对自愿召回的批次的问题缺乏调查。此外，企业未能确定其他批次是否受到影响，也未能对在美国销售的其他批次的留样进行检验。
In your response, you identify that the “more probable root cause for the introduction of Benzene was from the (b)(4)” and that “this was due to the fact that not all grades and all manufacturing processes of (b)(4) result in the same purity.” However, your response does not provide evidence from the out-of-specification (OOS) investigation or formal risk assessment process which led to this conclusion, nor does the response address the root cause for the unacceptable levels of the acetal and acetaldehyde impurities.
在企业的回复中，确认“引入苯的更可能的根本原因来自xx”，并且“这是由于并非所有等级和xx的所有生产工艺都产生相同的纯度。”然而，企业的回复没有提供OOS调查或正式风险评估过程的证据，导致了这个结论，也没有说明乙醛含量和乙醛杂质水平不可接受的根本原因。
Furthermore, drug products must be tested for identity, strength, quality, and purity prior to release and distribution. Manufacturers are required to establish and validate or verify analytical methods and procedures to ensure the accuracy, sensitivity, specificity, and reproducibility of testing. Considering the known risk of benzene contamination, including the FDA test results demonstrating benzene, a finished product specification for benzene in your hand sanitizers is appropriate under 21 CFR 211.160(b).
此外，药品在放行和销售前必须进行鉴别、规格、质量和纯度检验。要求生产厂家建立并确认或验证分析方法和程序，以确保检测的准确性、灵敏度、专一性和可重复性。考虑到苯污染的已知风险，包括FDA测试结果显示苯，洗手液中苯的成品规范符合21 CFR 211.160(b)。
As of the date of this letter, you have yet to provide complete impurity results of the other batches in U.S. distribution. We acknowledge that you expanded the voluntary recall to include additional batches of hand sanitizer manufactured with common components used in the recalled batches. However, we remain concerned about the quality of the individual components and the remaining batches of hand sanitizer drug product still in U.S. distribution which lack adequate testing.
截至本函日期，企业还没有提供在美国销售的其他批次的完整的杂质结果。我们了解到企业扩大了自愿召回范围，包括召回批次中使用常见成分生产的其它批次洗手液。然而，我们仍然关注在美国销售的个别成分和剩余批次的洗手液药品的质量，这些产品缺乏足够的测试。
Water System
水系统
You lacked investigations into multiple microbiological monitoring results from your water system that exceed action limits. For example, you did not investigate multiple results above your total aerobic microbial count action limit of (b)(4) cfu/g. Furthermore, during the inspection, data to support the quality of the water system before July 2021, was not available nor provided.
企业缺乏对水系统超过行动限的多种微生物监测结果的调查。例如，企业没有调查超过企业总需氧微生物计数行动限(xx cfu/g)的多个结果。此外，在检查期间，也没有提供支持2021年7月之前水系统质量的数据。
You acknowledged these deficiencies in your response, but failed to include a risk assessment or retrospective review to determine whether the out-of-limit results and/or the lack of water testing results have impacted released drug product; nor did you discuss the impact of the failure to follow your established procedures regarding microbiological events.
企业在回复中承认了这些缺陷，但未能包括风险评估或回顾性审查以确定超标结果和/或水试验结果的缺乏是否影响了已放行药品;企业也没有讨论不遵守关于微生物事件的既定程序的影响。
Inadequate investigations can lead to unidentified root causes, ineffective corrective action and preventive action (CAPA), and recurring problems that compromise the ability to produce safe and effective drug products.
不充分的调查可能会导致无法识别的根本原因，无效的纠正措施和预防措施(CAPA)，以及反复出现的问题，从而影响生产安全有效药品的能力。
In response to this letter, provide:
针对本函，请提供：
A comprehensive independent assessment of your overall system for investigating deviations, discrepancies, complaints, OOS results, and failures. Provide a detailed action plan to remediate this system. Your action plan should include, but not be limited to, significant improvements in investigation competencies, scope determination, root cause evaluation, CAPA effectiveness, quality unit oversight, and written procedures. Address how your firm will ensure all phases of investigations are appropriately conducted.
对企业的偏差、差异、投诉、OOS结果和失败调查的整体系统进行全面的独立评估。提供一份详细的行动计划来纠正这个系统。企业的行动计划应包括但不限于:调查能力、范围确定、根本原因评估、CAPA有效性、质量部门监督和书面程序的显著改进。说明贵公司将如何确保所有阶段的调查都得到适当执行。
Summary of all available water system results from all parties (whether third party laboratory or in-house testing) including the identification of organism for any results (whether from potable water or points of use ports) above the alert and action levels or for any organism presence detected during the selected indicator organism test.
所有各方(第三方实验室或内部测试)提供的所有供水系统结果汇总，包括对高于警报和行动级别的任何结果(饮用水或使用点端口)的微生物的鉴定，或选定的指示性生物体测试中检测到的任何生物体的存在。
A summary of all results including methanol, benzene, acetal, and acetaldehyde for all hand sanitizer batches released and distributed. If such testing reveals substandard quality drug products, take rapid corrective actions, such as notifying customers and product recalls.
放行和分发的所有洗手液批次的所有结果汇总，包括甲醇、苯、缩醛和乙醛。如果此类检测发现药品质量不合格，应迅速采取纠正措施，如通知客户和产品召回。
2. 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)).
2. 企业未能对每一原辅料进行鉴别和符合性检验，以确定符合纯度，规格和质量的所有适用标准。(21 CFR 211.84(d)(1) 和 (2))
Your firm failed to test incoming components prior to their use in the manufacture of artnaturals SCENT FREE HAND SANITIZER. You also relied on your suppliers’ certificate of analysis (COA) without establishing the reliability of your component suppliers’ test analyses at appropriate intervals, or used incoming components without COAs. For example, one lot of carbomer material was received from an unapproved supplier and a second lot was received without a COA from an unknown supplier. These components were used in the manufacture of hand sanitizer drug products; specifically in two hand sanitizer batches which were subsequently recalled because of the presence of impurities.
贵公司未能在进厂原材料用于生产无香精洗手液之前对其进行测试。企业还依赖供应商的分析证书(COA)，而没有建立企业的供应商在适当的时间间隔内测试分析的可靠性，或者使用没有COA的进厂原辅料。例如，有一批卡波姆材料从一个未经批准的供应商那里收到，而第二批从一个不知名的供应商那里收到了没有COA的原辅料。这些原辅料用于洗手液药品的生产;特别是随后因含有杂质而被召回的两批洗手液。
In your response, you stated that your process to manage shipments under quarantine is under revision and that all hand sanitizer batches that were shipped under quarantine had “(b)(4).” However, your response does not explain whether product had been distributed (b)(4) nor was an adequate investigation and retrospective review performed to determine whether other components were received from unapproved suppliers and/or with incomplete testing of the incoming component prior to their use in production of drug products. Additionally, your response does not address how you will prevent the use of poor-quality components in future batches.
企业在答复中指出，待检装运管理流程正在修订中，所有待检装运的洗手液批次均已" (b)(4) "。然而，企业的回复没有解释产品是否已销售，也没有进行充分的调查和回顾性审查，以确定其他成分是否从未经批准的供应商处收到，以及/或来料成分在用于药品生产前是否进行了不完整的测试。另外，企业的回复没有说明将如何防止在未来批次中使用低质量的原辅料。
Component testing is fundamental to quality. Without adequate testing, you do not have scientific evidence that your raw materials conform to appropriate specifications before use in the manufacture of drug products.
原辅料检验是质量的基础。没有充分的检测，企业就没有科学证据证明原料在用于药品生产之前符合适当的规格。
In your response to this letter, provide:
针对本函，请提供：
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 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.
描述企业将如何检验每个原辅料批次，以确保其符合所有合适的鉴别、规格、质量和纯度标准。如果企业打算接受供应商COA的任何结果，而不是检验每个原辅料批次的规格、质量和纯度，请说明企业将如何通过初始验证和定期再验证来稳固地建立企业供应商结果的可靠性。此外，包括对每个进厂原辅料批次始终进行至少一次特定鉴别的承诺。
Investigation and risk assessment regarding all instances for all drug products where material was received without COA, or where the material may not have been sampled, tested, or released by the quality unit prior to use in production.
对所有药品进行调查和风险评估，包括在没有COA的情况下接收原料，或者原料在用于生产前可能没有被质量部门抽样、检验或放行。
3. Your firm failed to establish adequate written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess, and your firm’s quality control unit did not review and approve those procedures, including any changes (21 CFR 211.100(a)).
3. 企业未能制订足够的书面生产和工艺控制规程，以保证药品所声称的或表明拥有的鉴别、规格、质量和纯度；贵公司的质量控制部门没有审核和批准这些规程，包括任何变更(21 CFR 211.100(a))。(21 CFR 211.100(a))。
You use water as a component in the manufacture of your drug products. You failed to ensure the water system is designed, maintained, and monitored in a validated state. For example, validation of your water system has not been performed and you were unable to provide microbiological monitoring of water system before July 2021.
企业在药品生产中使用水作为一种成分。未能确保水系统的设计、维护和监控处于有效的状态。例如，的水系统没有进行验证，无法在2021年7月之前提供水系统的微生物监测。
Your response states that you expect to complete validation (after the systematic review) by the (b)(4). However, your response is inadequate because you have not provided sufficient details how you will ensure that your current water system design is appropriate for its intended use while the system is being remediated. Furthermore, your sampling frequency and your microbial testing is inadequate since water system samples are not currently monitored for the presence of Burkholderia Cepacia Complex (BCC).
企业的回复中说，希望xx完成(系统评审后)验证。然而，企业的回复是不充分的，因为没有提供足够的细节，在系统修复过程中，企业将如何确保当前的水系统设计符合预期用途。此外，企业的采样频率和微生物检测是不充分的，因为目前没有监测供水系统样品是否存在洋葱伯克霍氏菌复合物(BCC)。
The lack of data regarding the state of control of your water system poses a potential risk objectionable microbiological contamination into your drug products. Pharmaceutical water must be suitable for its intended use and routinely tested to ensure ongoing conformance with appropriate chemical and microbiological attributes.
缺乏关于企业水系统控制状态的数据，对药品造成了不良微生物污染的潜在风险。制药用水必须适合其预期用途，并进行常规测试，以确保持续符合适当的化学和微生物属性。
In your response to this letter, provide:
针对本函吗，请提供：
A comprehensive remediation plan for the design, control, and maintenance of the water system including robust monitoring program to ensure the remediated system design consistently produces water adhering to (b)(4), United States Pharmacopeia (USP) monograph specifications and appropriate microbial limits.
水系统的设计、控制和维护的全面整改计划，包括充分的监测程序，以确保整改后的系统设计生产的水始终符合美国药典(USP)各论规范和适当的微生物限度。
Validation report for the water system obtained after all identified design issues have been fully corrected and any maintenance repairs have been completed. Include the system validation protocol, the complete test results, and the final validation report.
在所有确定的设计问题完全纠正并完成所有维护维修后，获得水系统的验证报告。包括系统验证方案、完整的测试结果和最终的验证报告。
Your total microbial count limits to monitor whether this system is producing water suitable for the intended uses for each of your products.
企业的总微生物计数限制用于监测该系统是否生产出适合于每个产品预期用途的水。
A detailed risk assessment addressing the potential effects of the observed water system failures on the quality of all drug products currently in U.S. distribution. Specify actions that you will take in response to the risk assessment, such as customer notifications and product recalls.
一份详细的风险评估，说明观察到的水系统故障对目前在美国销售的所有药品质量的潜在影响。指定企业将采取的响应风险评估的操作，例如客户通知和产品召回。
Objectionable Organisms
有害生物
For further information regarding the significance of Burkholderia Cepacia Complex and other objectionable contamination of non-sterile, water-based drug products, see FDA’s advisory notice posted on July 7, 2021, at https://www.fda.gov/drugs/drug-safety-and-availability/fda-advises-drug-manufacturers-burkholderia-cepacia-complex-poses-contamination-risk-non-sterile
关于洋葱伯克霍尔德菌复合物和其他非无菌、水基药品的不良污染的重要性的进一步信息，请参阅2021年7月7日发布的FDA咨询通知，网址为https://www.fda.gov/drugs/drug-safety-and-availability/fda-advises-drug-manufacturers-burkholderia-cepacia-complex-poses-contamination-risk-non-sterile
Quality Systems
质量体系
Your firm’s quality systems are inadequate. See FDA’s guidance document Quality Systems Approach to Pharmaceutical CGMP Regulations for help implementing quality systems and risk management approaches to meet the requirements of CGMP regulations 21 CFR, parts 210 and 211 at https://www.fda.gov/media/71023/download.
贵公司的质量体系不充分。参见FDA的指导文件《药品CGMP法规的质量体系方法》，帮助实施质量体系和风险管理方法，以满足CGMP法规21 CFR, 210和211部分的要求，网址是https://www.fda.gov/media/71023/download。
CGMP Consultant Recommended
CGMP顾问推荐
Based 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 assist your firm in meeting CGMP requirements. The qualified consultant should also perform a comprehensive audit of your entire operation for CGMP compliance and the consultant should also evaluate the completion and efficacy of any identified corrective actions and preventive actions before you pursue resolution of your firm’s compliance status with the FDA.
基于FDA在贵公司发现的违规行为的性质，企业应该聘请符合21 CFR 211.34要求的顾问来协助贵公司满足CGMP要求。合格的顾问还应对企业的整个运营进行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，顾问还应评估任何确定的纠正措施和预防措施的完成情况和有效性。
Conclusion
结论
The 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.
在这封信中引用的违规行为并不是企业设施中存在的所有违规行为的清单。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其他违规行为的发生。
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.
请及时纠正违规行为。未能及时并充分地解决该问题可能会导致无需另行通知的监管或法律行动，包括但不限于扣押和禁令。未解决的违规行为也可能妨碍其他联邦机构授予合同。
Failure to address violations may also cause the FDA to withhold issuance of Export Certificates. The 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.
未能解决违规问题还可能导致FDA拒绝签发出口证书。FDA可能会拒绝批准贵公司作为药品生产商的新申请或补充申请，直到任何违规行为被完全解决，并且我们确认企业符合CGMP。我们可能会重新检查，以核实企业是否完成了针对任何违规行为的纠正措施。
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 complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion.
这封信告知企业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，我们将继续评估企业的活动和做法。如果企业不能在15个工作日内完成纠正措施，说明延迟的原因和完成计划。
Please send your electronic reply to ORAPHARM4_Responses@FDA.HHS.GOV or mail your reply to:
CDR Steven E. Porter, Jr.
Director, Division of Pharmaceutical Quality Operations IV
U.S. Food & Drug Administration
19701 Fairchild Road
Irvine, California 92612-2506
Please identify your responses with the unique identifier: CMS 631432
If you have questions regarding the contents of this letter, please contact Andrew Haack, Compliance Officer by telephone at 206-340-8212 or email at Andrew.Haack@fda.hhs.gov.
Sincerely,
/S/
Lance M. De Souza
Acting Director, Division of Pharmaceutical Quality Operations IV
CC:
Mr. Yosef Nourollah
CEO
Virgin Scent Inc. dba Artnaturals
2390 Crenshaw Blvd, PMB #702
Torrance, CA 90501
__________________________
1 Due to an increased demand for alcohol-based hand sanitizers during the COVID-19 pandemic, the 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. The guidance was withdrawn effective December 31, 2021 (86 Fed Reg at 56960). This guidance communicated the agency’s temporary policy that we did not intend to take action against firms for CGMP violations under section 501(a)(2)(B) of the FD&C Act if such firms prepared 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 included preparation of hand sanitizer products using only the ingredients and formulas set forth in the guidance. Because Gordon Laboratory hand sanitizer drug products were not consistent with the formulations described in these guidances, they did not fall within any temporary agency policy not to take action against firms manufacturing hand sanitizer products for violations of section 505 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:2019冠状病毒病(COVID-19)期间制备某些酒精基洗手液产品的临时政策》，并随后多次更新该指南。该指引于2021年12月31日撤销(86Fed Reg at 56960)。该指南传达了FDA的临时政策，即如果这些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(或用于卫生保健人员的洗手液)，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某些情况。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。由于Gordon Laboratory洗手液药品产品与这些指南中描述的配方不一致，它们不属于任何临时机构政策，即不对生产洗手液产品的公司采取行动，以违反FD&C法案第505条。
