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发表于 2018-8-28 14:07:21
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FDA警告信：印度JT Cosmetics & Chemicals 20180727
本帖最后由 roadman 于 2018-8-28 14:13 编辑
（做化妆品和化学品的也开始做OTC药了 ）
原创： JULIA Julia法规翻译 1周前
Warning Letter 320-18-66 July 27, 2018
Mr. Chirag Arora, Administration Director
JT Cosmetics & Chemicals Pvt. Ltd.
53 Kalol GIDC Estate, Panchmahal District,Gujarat, 389330, India
Dear Mr. Arora:
The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, JT Cosmetics & Chemicals Pvt. Ltd. at 53 KalolGIDC Estate, Panchmahal District, Gujarat, from February 26 to 28, 2018.
美国FDA于2018年2月26-28日检查了你们位于印度古吉拉特邦的JT Cosmetics & Chemicals Pvt. Ltd.生产场所。
This warning letter summarizes significant violations of current good manufacturing practice (CGMP) regulations for finishedpharmaceuticals. See 21 CFR, parts 210 and 211.
本警告信总结了制剂生产严重违反CGMP的行为。参见21CFR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 Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).
由于你们的制剂生产、加工、包装或保存的方法、场所或控制不符合CGMP要求，你们的制剂根据FDCA的501(a)(2)(B)以及21 U.S.C. 351(a)(2)(B)被认为是掺假药品。
JT Cosmetics & Chemicals Private Limited manufactures unapproved new drug and misbranded drug products. Specifically, the over-the-counter (OTC) drug product Diva’s Vaporizing Chest Rub is an unapproved new drug in violation of section 505(a) of the FD&C Act, 21U.S.C. 355(a). Furthermore, the OTC drug products Diva’s Blue Ice, Rubbing Alcohol, and Diva’s Vaporizing Chest Rub are misbranded under section 502(x) ofthe FD&C Act, 21 U.S.C. 352(x). Introduction of Diva’s Vaporizing Chest Rubinto interstate commerce is prohibited under 301(d) of the FD&C Act, 21U.S.C. 331(d) and the introduction of Diva’s Blue Ice, Rubbing Alcohol, and Diva’s Vaporizing Chest Rub into interstate commerce is prohibited under 301(a) of the FD&C Act, 21 U.S.C. 331(a).
JT Cosmetics & Chemicals Private Limited生产未经批准的新药和冒牌药品。具体来说，OTC药品Diva’s VaporizingChest Rub是一种未经批准的新药，违反了FDCA第505(a)部分21 U.S.C. 355(a)。另外，OTC药品Diva’s Blue Ice、Rubbing Alcohol和Diva’s VaporizingChest Rub依据FDCA第502(x)条款21 U.S.C. 352(x)为冒牌药品。将Diva’sVaporizing Chest Rub引入州际贸易是FDCA第301(d)条款21 U.S.C. 331(d)所禁止的。将Diva’sBlue Ice、Rubbing Alcohol和Diva’s Vaporizing Chest Rub引入州际贸易也是FDCA第301(a)条款21 U.S.C. 331(a)所禁止的。
In your April 20, 2018, response, you acknowledged the significance of the CGMP observations and stated that your firm expects to complete all corrections within three months. However, you provided no further information and did not commit to any specific corrective actions.
在你们2018年4月20日的回复中，你们说知晓CGMP缺陷的严重性，并声明你们公司预期将在3个月内完成所有纠正措施。但是，你们并未提供更多信息，亦未承诺任何具体的纠正措施。
During our inspection, our investigators observed specific violations including, but not limited to, the following.
检查期间，我们的调查人员发现的具体问题包括但不仅限于以下：
1. Your firm failed to perform, 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, and for each batch ofdrug product required to be free of objectionable microorganisms, appropriate laboratory testing, as necessary (21 CFR 211.165(a) and (b)).
你公司未能在放行对每批药品进行适当的化验室检测，确定其是否符合药品最终质量标准，包括每种活性鉴别和剂量，以及对不得检出致病菌的每批药品在必要时进行适当的化验室检测(21 CFR 211.165(a) and (b))。
Your firm released your OTC drug products without testing for the identity and strength of active ingredients. Without this testing you cannot determine whether your drug products conform to specifications.
你公司未检测活性成分的鉴别和剂量即放行了你们的OTC药品。没有这些检测，你们无法确定你们的药品是否符合质量标准。
Your personnel also informed our investigators during the inspection that microbiological test results recorded on your certificates of analysis (COA) in support of your decision to distribute drugs were falsified, and the testing had not been performed.
你们的人员在检查中亦告诉我们调查人员在你们的COA上所记录的用于支持你们药品销售决策的微生物检验结果是捏造的，你们并未执行这些检测。
In addition, you lacked procedures for finished product testing that you do perform and records of your testing.
此外，你们还缺少成品检测程序以及检测记录。
In response to this letter provide:在回复此函时请提交
all chemical and microbial test methods and specifications used to analyze each lot of your OTC drug products prior to a lot disposition decision; and
所有在批处置决策之前用于分析你们每批OTC药品的化学和微生物检验方法和质量标准
a summary of test results obtained from testing retain samples of all OTC drug products within expiry that have been distributed in the United States. Include test results for identity and strength of active ingredients, and all other appropriate chemical and microbial quality attributes.
对所有销往美国仍在效期内的所有OTC药品的留样检测所得结果的汇总，包括活性成分的鉴别和剂量，以及所有其它适当的化学和微生物质量属性。
2. Your firm failed to testsamples of each component for conformity with all appropriate written specifications for identity, purity, strength, and quality (21 CFR 211.84(d)(1) and (2)).
你公司未执行至少一项检测来确认药品的每种成分的鉴别。你公司说未通过对供应商检测结果以适当时间间隔进行验证的方式来建立组份供应商分析的可靠性却依赖于其结果替代某些检测(21 CFR 211.84(d)(1) and (2))。
Your firm failed to test incoming raw materials, including active ingredients, for their identity, purity, strength, or other quality attributes. You also did not establish the reliability of COA from your unqualified suppliers. In addition, your procedures for receiving, handling, storing, sampling, and testing components are inadequate.
你们公司未检测进厂物料，包括活性成分，的鉴别、纯度、剂量和其它质量属性。你们亦未证明你们未经确认的供应商的COA的可靠性。此外，你们的组份接收、处置、存贮、取样和检测程序是不充分的。
In response to this letter provide:
在回复此函时请提交：
quality control release specifications for all incoming components and the tests you perform for each lot;
所有进厂组份的QC放行质量标准以及你们对每个批次的实施的检测项；
a summary of test results obtained from full testing of all your incoming components to validate the COA from each raw material manufacturer;
为验证来自每个原料生产商的COA而对所有进厂组份全检所获得的检测结果汇总；
a summary of your procedures for qualifying and overseeing the adequacy of contract facilities that test the OTC drug products you manufacture;
对你们确认和监管检测你们所生产的OTC药品的外包场所充分性程序摘要；
a comprehensive, independent review of your material system to determine whether all containers, closures, and ingredients from each supplier are adequately qualified, and assigned appropriate expiration or retest dates; and whether incoming material lot controls are adequate to prevent use of unsuitable containers, closures, and components.
一份对你们物料体系的全面独立审核，以确定是否所有来自每一个供应商的容器密闭器和组份均经过充分确认，并给定了适当的有效期或复验期，以及进厂物料批控制是否足以防止使用不适当的容器、密闭器和组份。
3. Your firm failed toestablish and follow written procedures for the preparation of master production and control records designed to assure uniformity from batch tobatch. Your firm failed to prepare batch production and control records with complete information relating to the production and control of each batch ofdrug product produced (21 CFR 211.186(a) and 211.188).
你公司未建立并遵守书面的设计用以确保批间一致性的主生产和检测记录制订程序。你公司未制订包含有所生产的每批药品完整生产和检测信息的批生产和检测记录(21 CFR 211.186(a) and 211.188)。
Your master and batch production records are inadequate.They do not include:
你们的主生产记录和批生产记录是不充分的。其中未包括：
manufacturing instructions;
生产指令
actual amounts of components weighed and added to the batch;
组份实际称量和投料数量
identification of major equipment and lines used;
所用主要设备和生产线编号
sampling information;
取样信息
yield; and
收率
packaging and labeling records, including inspection of the area before and after use and information pertaining to containers, closures, and labels.
包装和标签记录，包括在使用前后对生产区域的检查，以及容器密闭器和标签的信息
In response to this letter, provide a risk assessment ofproducts released to the U.S. market without adequate and approved production and control documentation. Also provide procedures you have implemented or revised to assure production records are completed as required and reviewed by your quality unit prior to release of products for distribution.
在回复此函时，请提交一份缺失充分和经批准的生产和检测文件但放行至美国市场的产品的风险评估。亦请提交你们已实施或已修订用以确保生产记录完整并由你们质量部门在产品销售放行之前进行审核的程序。
4. Your firm failed to establish a quality control unit and procedures applicable to the quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products, including drug products manufactured, processed, packed or held under contract by another company. Your firm failed to establish adequate written responsibilities and procedures applicable to the quality control unit. (21 CFR 211.22(a) and (d)).
你公司未建立质量控制部门以及适用于质量部门的程序，在其中规定其批准或拒收所有组份、药品容器密闭器、中间体、包材、标签和成品，包括另一公司委托生产、加工、包装或存贮的药品的职责和权力。你公司未制订足够的质量部门适用书面职责和程序。
Your firm lacks an adequate quality unit and failed to have adequate procedures for numerous functions of the quality unit. You had inadequate or non-existent procedures for these manufacturing operations:
你公司缺乏足够的质量部门，质量部门大量职能不具备足够的程序。你们以下生产运作的程序不充分或缺失：
quality unit operations;
质量部门运作
production;
生产
laboratory testing;
化验室检测
raw material handling;
原料处理
training;
培训
packaging and labeling;
包装和标签
equipment cleaning; and
设备清洁
stability
稳定性
In response to this letter, provide a comprehensive assessment and a corrective action and preventive action (CAPA) plan to ensurethat you establish an effective quality unit with appropriate authority, responsibilities and resources. Your response should also include a detailed procedure describing your remediated quality unit’s responsibilities.
在回复此函时，请提交一份全面的评估以及一份确保你们会建立有效的质量部门并具备适当权力、职责和资源的CAPA计划。你们的回复还应包括一份描述你们所弥补的质量部门职责的详细程序。
Quality Unit Authority
质量部门权力
Significant findings in this letter indicate that your quality unit is not able to fully exercise its authority and responsibilities.Your firm must provide the quality unit with the appropriate authority and sufficient resources to carry out its responsibilities and consistently ensure drug quality. See FDA’s guidance document, Quality Systems Approach to Pharmaceutical CGMP Regulations, for help implementing quality systems andrisk management approaches to meet the requirements of CGMP regulations (21CFR, parts 210 and 211), at https://www.fda.gov/downloads/Drugs/Guidances/UCM070337.pdf.
在此函中所记录的重大缺陷显示你们质量部门无法全面履行其权力和职责。你公司必须为质量部门提供适当的权力和足够的资源，以执行其职责并持续确保药品质量。参见FDA指南文件。
Data Integrity Remediation
数据完整性补救措施
Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture. In response to this letter, provide the following.
你们的质量体系不能充分确保数据的准确性和完整性，无法支持你们生产的药品的安全性、有效性和质量。在回复此函时请提交以下内容：
A. A comprehensive investigation into the extent of the inaccuracies in data, records, and reporting, including results of the data review for drugs distributed to the United States. Include adetailed description of the scope and root causes of your data integrity lapses.
一份对数据记录和报告，包括对销售至美国的药品的数据审核的结果，的不准确性程度的全面调查，包括对你们数据完整性问题范围和根本原因的详细描述。
B. A current risk assessment of the potential effects of the observed failures on the quality of your drugs. Your assessment should include analyses of the risks to patients caused by the releaseof drugs affected by a lapse of data integrity, and risks posed by ongoing operations.
对你们药品质量中所发现的不合格情况的潜在影响的当前风险评估。你们的评估应包括由于受到数据完整性问题影响的药品放行导致的患者风险的分析，以及持续运营所具有的风险。
C. A management strategy for your firm that includes the details of your global corrective action and preventive action plan. The detailed CAPA plan should describe how you intend to ensurethe reliability and completeness of all data generated by your firm, including all laboratory data, manufacturing records, and all data submitted to FDA.
你们公司的管理策略，包括你们全球CAPA计划详细情况。该份详细的CAPA计划应说明你们将如何确保你们公司所生成所有数据，包括所有实验室数据、生产记录和所有提交给FDA的申报数据，的可靠性和完整性
CGMP Consultant Recommended
CGMP顾问建议
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 assist your firm in meeting CGMP requirements. We also recommend that the qualified consultant perform a comprehensive audit of your entire operation for CGMP compliance, and evaluate the completeness and effectiveness of corrective actions and preventive actions before you pursuere solution of your firm’s compliance status with FDA.
依据我们在你们工厂发现的违规情况，我们强烈建议你们使用一位有21 CFR211.34所述资质的顾问来协助你们公司符合CGMP要求。我们还建议具备资质的第三方对你们全面操作合规性进行综合审计，并在你们寻求公司符合FDA合规状态之前评估所有CAPA的完整性和有效性。
Your use of a consultant does not relieve your firm’s obligation to comply with CGMP. Your firm’s executive management remains responsible for fully resolving all deficiencies and ensuring ongoing CGMP compliance.
你们使用顾问并不解除你们公司符合CGMP的义务。你们公司的高级管理层仍负有义务全面解决所有缺陷，确保持续CGMP符合性。
Unapproved New Drug Charges
未批准新药指控
Diva’s Vaporizing Chest Rub
Examples of claims observed on your product label for Diva’s Vaporizing Chest Rub that establish the intended uses of the product include,but may not be limited to, the following:
在你们Diva’s VaporizingChest Rub药品标签上看到的声明中设定药品用途的例子包括但不仅限于：
“Nasal Decongestant . . . Cough Suppressant . . . TopicalAnalgesic . . . To temporarily relieve nasal congestion, chest congestion andcough due to the common cold. Temporarily relieves minor aches and pains.”
“鼻血管收缩药……镇咳剂……局部止痛药……用于暂缓由于普通感冒引起的鼻塞、胸部充血和咳嗽。暂缓轻微疼痛。”
Based on the above claims Diva’s Vaporizing Chest Rub 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 the diagnosis, cure, mitigation,treatment, or prevention of disease, and/or under section 201(g)(1)(C) of theFD&C Act, 21 U.S.C. 321(g)(1)(C), because it is intended to affect the structure or any function of the body. Specifically, this product is intendedas a nasal decongestant, antitussive (cough suppressant), and externalanalgesic.
根据上述声明，Diva’sVaporizing Chest Rub即为FDCA第201(g)(1)(B)条款21 U.S.C. 321(g)(1)(B)所定义的“药品”，因为其将用于诊断、治愈、缓解、治疗或防治疾病。依据FDCA第201(g)(1)(C)条款21 U.S.C. 321(g)(1)(C)该产品亦为药品，因为其将用于影响人体的结构或功能。具体来说，该药品是用作鼻血管收缩药、镇咳剂和外用镇痛药。
OTC drug products such as Diva’s Vaporizing Chest Rub thatare intended for nasal decongestant and cough suppressant indications aresubject to the Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products final rule (cough/cold final rule), see 21 CFR 341. Diva’s VaporizingChest Rub must meet the formulation and labeling requirements described in thecough/cold final rule for both nasal decongestants and cough suppressants.However, the product is not labeled or formulated in accordance with this finalrule for reasons explained below.
OTC药品如Diva’sVaporizing Chest Rub，用作鼻血管收缩药和镇咳剂需符合感冒、咳嗽、过敏、支气管扩张药和平喘药最终规定（咳嗽/感冒最终规定），参见21CFR341。Diva’s Vaporizing Chest Rub必须符合咳嗽/感冒最终规定中所述的鼻血管收缩药和镇咳剂配方和标签要求。但是，该产品并未按此最终规定要求标签或配方。
Diva’s Vaporizing Chest Rub is indicated, in part, for useas a nasal decongestant. However, the labeled active ingredients, menthol,camphor, and eucalyptus oil, are not included active ingredients for nasaldecongestant drug products as described in the cough/cold final rule, see 21CFR 341.20.
Diva’s Vaporizing Chest Rub部分显示可用作鼻血管收缩药。但是，所标示的活性成分，薄荷脑、樟脑和桉叶油，并不在咳嗽/感冒最终规定（参见21CFR341.20）所述鼻血管收缩药药品活性成分内。
Your product also is indicated, in part, as a cough suppressant. The final rule requires that topical cough suppressants contain2.6% to 2.8% menthol, see 21 CFR 341.74(d)(2)(ii). However, your product is formulated with menthol 1.0%. Furthermore, Diva’s Vaporizing Chest Rub islabeled to contain 1.0% eucalyptus oil. According to 21 CFR 341.40(u), camphor and menthol may be combined with 1.2% to 1.3% eucalyptus oil provided that the product is available in a suitable ointment vehicle labeled in accordance withthe allowable indications for cough suppressant drug products. Since Diva’s Vaporizing Chest Rub contains less than the required amount of eucalyptus oilthat is allowed to be combined with camphor and menthol, your product’s active ingredients do not meet the requirements for a permitted combination of active ingredients as described in 21 CFR 341(u).
你们的产品还部分可用作镇咳剂。最终规定要求局部镇咳药含有2.6%-2.8%的薄荷脑，参见21 CFR 341.74(d)(2)(ii)。但是，你们的药品配方中含薄荷脑为1.0%。另外，Diva’s Vaporizing Chest Rub标示含有1.0%桉叶油。依照21 CFR 341.40(u)要求，如果药品是按照允许的镇咳剂药品标示的适当软膏剂形式，樟脑和薄荷脑可与1.2-1.3%桉叶油并用。由于Diva’s Vaporizing Chest Rub含有少于所要求与樟脑和薄荷脑并用的桉叶油数量，你们药品的活性成分并不符合21 CFR 341(u)中所述的活性成分所允许的组合要求。
Thus, as formulated and labeled, Diva’s Vaporizing Chest Rubdoes not comply with the final rule described above. Furthermore, we are notaware of sufficient evidence to show Diva’s Vaporizing Chest Rub as formulatedand labeled, is generally recognized as safe and effective. Therefore, thisproduct is a new drug within the meaning of section 201(p) of the FD&C Act,21 U.S.C. 321(p). As a new drug, Diva’s Vaporizing Chest Rub may not be legallymarketed in the United States absent approval of an application filed inaccordance with section 505 of the FD&C Act, 21 U.S.C. 355(a). Diva’sVaporizing Chest Rub is not the subject of an FDA-approved application, andtherefore, the current marketing of this product violates section 505(a) of theFD&C Act, 21 U.S.C. 355(a)). Introduction of such products into interstatecommerce is prohibited under section 301(d) of the FD&C Act, 21 U.S.C.331(d).
因此，鉴于其配方和标示，Diva’s Vaporizing Chest Rub并不符合上述最终规定。另外，我们并未得到足够证据证明Diva’s Vaporizing Chest Rub的配方和标签被公认为安全有效。因此该药品按FDCA第201(p)部分21 U.S.C. 321(p)规定属于新药。作为一种新药，在没有依据FDCA第505条款21 U.S.C. 355(a)提交申报材料并获得批准前提下，Diva’s Vaporizing Chest Rub在美国上市销售是非法的。Diva’s Vaporizing Chest Rub并不具备经FDA批准的申报，因此目前其上市销售违反了FDCA第505(a)条款21 U.S.C. 355(a)。将此产品引入州际贸易是FDCA第301(d)条款21 U.S.C. 331(d)所禁止的。
Misbranding Charges
冒牌指控
Diva’s Blue Ice, Rubbing Alcohol, and Diva’s VaporizingChest Rub
Examples of claims observed on your product labels forDiva’s Blue Ice, Rubbing Alcohol, and Diva’s Vaporizing Chest Rub that establish the intended uses of the products include, but may not be limited to,the following:
在你们产品Diva’s Blue Ice、Rubbing Alcohol和Diva’s Vaporizing Chest Rub标签上看到的声明说这些产品的既定用途包括但不仅限于：
Diva’s Blue Ice:
“Soothing Analgesic Gel . . . Provides temporary relief ofminor aches and pains in muscles and joints associated with simple backache,strains, sprains, arthritis and sports injuries”
“舒缓止痛凝胶……暂缓因简单背痛、紧张、关节炎和运动受伤引起的轻微肌肉和关节疼痛”
Rubbing Alcohol:
“First Aid Antiseptic . . . First aid to help prevent therisk of infection in minor cuts, scrapes and burns”
“急救消毒剂……用于帮助阻止小的刀伤、擦伤和烧伤伤口感染”
Diva’s Vaporizing Chest Rub:
“Nasal Decongestant . . . Cough Suppressant . . . TopicalAnalgesic . . . To temporarily relieve nasal congestion, chest congestion andcough due to the common cold. Temporarily relieves minor aches and pains.”
“鼻血管收缩药……镇咳剂……局部止痛药……用于暂缓由于普通感冒引起的鼻塞、胸部充血和咳嗽。暂缓轻微疼痛。”
Based on the above claims, Diva’s Blue Ice, Rubbing Alcohol,and Diva’s Vaporizing Chest Rub 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 thediagnosis, cure, mitigation, treatment, or prevention of disease, and/or undersection 201(g)(1)(C) of the FD&C Act, 21 U.S.C. 321(g)(1)(C), because theyare intended to affect the structure or any function of the body.
根据上述声明，Diva’sBlue Ice、Rubbing Alcohol和Diva’s Vaporizing Chest Rub按FDCA第201(g)(1)(B)部分21 U.S.C. 321(g)(1)(B)归为“药品“，因为其将用于诊断、治愈、缓解、治疗或防治疾病。依据FDCA第201(g)(1)(C)条款21 U.S.C. 321(g)(1)(C)该产品亦为药品，因为其将用于影响人体的结构或功能。
As OTC drugs, Diva’s Blue Ice, Rubbing Alcohol, and Diva’sVaporizing Chest Rub must comply with all of the requirements of section 502 ofthe FD&C Act and all pertinent regulations found in 21 CFR. However, theydo not for the reasons described below.
作为OTC药品，Diva’s Blue Ice、Rubbing Alcohol和Diva’s VaporizingChest Rub必须符合FDCA第502条款的所有要求，以及21CFR的所有相关规定。但是，这些药品并不符合，原因如下：
Diva’s Blue Ice, Rubbing Alcohol, and Diva’s VaporizingChest Rub are misbranded under section 502(x) of the FD&C Act, 21 U.S.C.352(x), because the products’ labels fail to disclose a domestic address ordomestic telephone number through which the responsible person may receive areport of a serious adverse event with such drug. Please note that section201(k) of the FD&C Act defines the term “label” as “...a display ofwritten, printed, or graphic matter upon the immediate container of anyarticle; and a requirement made by or under the authority of the FD&C Actthat any word, statement, or other information appear on the label shall not beconsidered to be complied with unless such…also appears on the outsidecontainer….” Therefore, the domestic address or domestic telephone number mustappear on your products’ immediate container labels and on the products’outside container labels if one exists.
Diva’s Blue Ice、Rubbing Alcohol和Diva’s Vaporizing Chest Rub依据FDCA第502(x)条款21 U.S.C. 352(x)为冒牌药品，因为这些产品的标签未显示美国地址或美国电话号码，使得负责人可以收到该药品的严重不良事件报告。请注意FDCA第201(k)部分将术语“标签”定义为“……在任何物质的直接包装容器上书写、印刷或绘制的内容；以及符合本章的官方要求，即标签上的任何文字、陈述或其他信息只有标示在这些物质零售包装的容器或包装的外侧，或者透过容器或包装材料可以清楚容易辨别才符合规定。”因此，美国地址或美国电话号码必须出现在你们的产品最小容器标签上和外容器标签上（如有）。
The introduction or delivery for introduction of amisbranded drug into interstate commerce is prohibited under section 301(a) ofthe FD&C Act, 21 U.S.C. 331(a). Therefore, the marketing of Diva’s BlueIce, Rubbing Alcohol, and Diva’s Vaporizing Chest Rub violates this provisionof the FD&C Act.
将冒牌药品引入州际贸易或运输是被FDCA第301(a)条款21U.S.C. 331(a)禁止的。因此，上市销售Diva’s Blue Ice、Rubbing Alcohol和Diva’s Vaporizing Chest Rub违反了FDCA的此条款。
Conclusion
结论
Violations cited in this letter are not intended as anall-inclusive list. You are responsible for investigating these violations, for determining the causes, for preventing their recurrence, and for preventing other violations.
此函中所引用的违规并不是全部。你们有责任对这些偏差进行调查，确定原因，防止其再次发生，防止其它偏差的发生。
FDA placed your firm on Import Alert 66-40 on June 11, 2018.
你公司已于2018年6月11日被放入进口禁令66-40项下。
Until you correct all violations completely and we confirm your compliance with CGMP, FDA may withhold approval of any new applications or supplements listing your firm as a drug manufacturer.
Failure to correct these violations may also result in FDA continuing to refuse admission of articles manufactured at JT Cosmetics & Chemicals Pvt. Ltd. at 53 Kalol GIDC Estate, Panchmahal District, Gujarat, intothe United States under section 801(a)(3) of the FD&C Act, 21 U.S.C.381(a)(3). Under the same authority, articles may be subject to refusal of admission, in that the methods and controls used in their manufacture do not appear to conform to CGMP within the meaning of section 501(a)(2)(B) of theFD&C Act, 21 U.S.C. 351(a)(2)(B).
在贵公司未能完成所有偏差纠正并且由我们确认你们符合CGMP之前，FDA可能会搁置所有将你公司列为药品生产的新申报和增补申报的批准。未能纠正这些偏差可能还会导致FDA依据FDCA第801(a)(3)条和21 U.S.C. 381(a)(3)拒绝接受在上述地址生产的产品进入美国。
After you receive this letter, respond to this office inwriting within 15 working days. Specify what you have done since our inspection to correct your violations and to prevent their recurrence. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion.
在收到此函后，请在15个工作日内回复至本办公室。在回复中说明自从检查后，你们做了哪些工作来纠正你们的偏差，防止其再次发生。如果不能在15个工作日内完成纠正措施，说明延迟的原因以及完成计划。
Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov or mail your reply to:
Brooke K. Higgins
Compliance Officer
U.S. Food and Drug Administration
White Oak Building 51, Room 4359
10903 New Hampshire Avenue
Silver Spring, MD 20993
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