FDA警告信：韩国Seindni Co., Ltd.

翻译：julia   来源： Julia法规翻译

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 Warning Letter 320-18-13

Return Receipt Requested

December 5, 2017

Mr. Il Chong Chung,

President and Owner

Seindni Co., Ltd.

610-304, 16, Gireum-ro,Seongbuk-gu

Seoul 02725

Korea 

Dear Mr. Chung:

The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Seindni Co.,Ltd. at 610-304, 16, Gireum-ro, Seongbuk-gu, Seoul from May 25–26, 2017.

  美国FDA于2017年5月25-26日检查了你们位于韩国首尔的Seindni Co., Ltd.生产场所。

This warning letter summarizes significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. 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。

Because your methods, facilities, or controls for manufacturing, processing, packing, or holding donot 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&CAct), 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。

We did not receive a response from your firm to the Form FDA 483 issued at the close of the inspection.

 我们未收到你公司针对检查结束时签发的FDA483的回复。

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 firmfailed 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)).

  你们公司未建立足够的质量部门和程序，使得质量部门具备职责和权力来批准或拒收所有成分、药品容器、密闭器、中间物料、包装物料、标签和药品，包括依据合同由另一公司秤、加工、包装或存贮的药品。你公司未能建立足够的书面职责和程序应用于质量控制部门(21 CFR 211.22(a) and (d))。

Your firm lacks an adequate quality unit.

 你公司缺乏足够的质量部门。

You utilize contract manufacturers to manufacture your over the counter (OTC) drug products distributed to the United States. You explained to our investigator that youmake finished product release decisions over the phone with your contract manufacturer, based on whether test results meet pre-established specifications. You do not have procedures covering your batch release process,and your quality unit lacks documentation to demonstrate acceptability of batch manufacturing and product quality.

 你们使用合同生产商生产你们销往美国的OTC产品。你们向我们的检查人员解释说你们通过电话与你们的合同生产做出产品放行决策，依据的是结果是否符合既定的质量标准。你们没有批放行程序，你们的质量部门缺乏文件记录来证明批生产和批质量的可接受性。

During the inspection, you confirmed that your contract manufacturers do not make your OTC drug products inconformance with drug CGMP. For example, you have released some drugs for which neither you nor your contract manufacturers conducted release tests foridentity and strength of active ingredients. As a result, some of your drugsare distributed without confirmation that they meet specifications for identity and strength of their active ingredients.

 在检查期间，你们确认你们的合同生产商并未依据药品CGMP生产你们的OTC药品。例如，你们已经放行了一些药品，但你们的合同生产商和你们都没有对这些药品的活性成分进行鉴定和剂量检测作为放行测试。因此，你们销售的药品中有一些并没有确认其符合其活性成分的鉴别和剂量。

In response to this letter,provide your written procedures establishing an adequate quality control unit with the authority to carry out its responsibilities, including, but notlimited to:

在回复此函时，你提供你们建立足够的质量部门的书面程序，并赋予他们权力来执行其职责，包括但不仅限于：

• Written procedures defining your batch review and release process; and

• 界定你们的批审核和放行流程的书面程序，以及

• Written procedures establishing your supplier and contractor qualification, selection, and oversight program, including procedures to ensure compliance with drug CGMP at all stages of manufacturing, processing, packing, or holding.

• 建立你们供应商和合同商资质确认、选择和监管计划的书面程序，包括确保在生产、加工、包装和存贮的所有阶段符合药品GMP的程序。

Use of Contract Manufacturers 使用合同生产商

All drugs, including OTC drugs,must be manufactured in conformance with drug CGMP. FDA is aware that many drug manufacturers use independent contractors, such as production facilities,testing laboratories, packagers, and labelers. FDA regards contractors as extensions of the manufacturer.

所有药品，包括OTC药品，均必须依据药品CGMP要求生产。FDA知晓许多药品生产商使用独立的合同生产商，如生产场所、检测化验室、包装商和贴标商。FDA认为此类合同生产商是生产商的延伸。

You are responsible for the quality of drugs you produce, regardless of agreements in place with your contract facility. You are required to ensure that drugs are made in accordance with section 501(a)(2)(B) of the FD&C Act to ensure safety, identity, strength, quality, and purity. See FDA’s guidance document, Contract Manufacturing Arrangements for Drugs: Quality Agreements, at https://www.fda.gov/downloads/drugs/guidances/ucm353925.pdf.

你们对于你们所生产的药品质量负有全部责任，即使你们与你们的合同场所签订有协议也一样。你们应确保药品依据FDCA第501（a）(2)(B)部分生产，以确保其安全性、鉴别、剂量、质量和纯度。参见FDA指南。参见FDA对此问题的指南。 

CGMP Consultant Recommended CGMP顾问建议

Based upon the nature of the violations we identified at your firm, we strongly recommend engaging aconsultant, qualified as set forth in 21 CFR 211.34, to assist your firm inmeeting 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 fully resolving all deficiencies and for ensuring ongoing CGMP compliance.

依据违规情况，我们强烈建议你们使用一位符合21CFR211.34要求的顾问来协助你们公司符合CGMP要求。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。

Labelling Concerns 标签关切

During the inspection, FDAcollected (b)(4) OTC drug labels, including labels for sunscreen and skin protectant OTC drug products. As a manufacturer and/or distributer of OTC drug products, it is the responsibility of your firm to comply with all requirements of Federal law and FDA regulations, and to ensure that your products are safe and effective and do not violate the provisions of the FD&C Act.

 在检查期间，FDA采集了某OTC药品的标签，包括防晒霜和护肤剂OTC药品。作为OTC药品的生产商和/或分销商，你们公司有义务符合联邦法律和FDA法规的所有要求，确保你们的产品是安全有效的，不违反FDCA的条款。

Products that are marketed and indicated for use as skin protectants, such as (b)(4) are subject to the Final Rule for Skin Protectant Drug Products for Over-the-Counter Human Use (21CFR 347). If the intent is to market these products as OTC drug products within the scope of FDA’s OTC Drug Review, they must meet the conditions set forth in 21 CFR 347. Otherwise, FDA-approved applications must be in effect.

 作为护肤品，如XX，销售和标识的产品受到人用OTC护肤药品最终规定的管理（21CFR347）。如果有意将这些产品作为FDA的OTC药品审核范围内的OTC药品上市销售，则这些药品必须符合21 CFR347所设定的条件。否则，必须要持有FDA批准的有效申报。

OTC sunscreen drugs, such as (b)(4) are subject to, among other regulations, the OTC Sunscreen Drug Products; Final Rule Labeling and Effectiveness Testing; Sunscreen Drug Products for Over-the-Counter Human Use, 21 CFR 201.327. Pending the finalization of the Sunscreen Drug Products for Over-the-Counter Human Use [Stayed Indefinitely] monograph, 21 CFR 352, FDA does not object to the marketing of sunscreen products that meet the formulation requirements under 21 CFR 352.10 and 352.20 in addition to all applicable final rules such as 21 CFR 201.327 and 21 CFR201.66. For example, your SPF products require a Drug Facts panel (21 CFR201.66) as well as directions and warnings as required by 21 CFR 201.327(e) and21 CFR 201.327(d) respectively.

 OTC防晒药品，如XX，受到OTC防晒药品、标签和有效性测试最终规定、人用OTC防晒药品、21CFR201.327及其它药品的约束。由于21 CFR352的人用OTC防晒药品各论尚未定稿，除所有适用的定稿规定如21CFR201.327和21CFR201.66外，FDA不会要求其符合21CFR352.10和352.20的配方要求。例如，你们的SPF产品要求有药品实情标签（21CFR201.66），以及21CFR 201.327（e）和21CFR 201.327（d）所分别要求的指导和警示。

Please note that dual language labeling with English and another language is permissible when labeled inaccordance to 21 CFR 201.15 and is not otherwise false or misleading. As statedin 21 CFR 201.15, “all words, statements, and other information required by or under authority of the act to appear on the label or labeling shall appearthereon in the English language” and “if the label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the act to appear on the label shall appear thereon inthe foreign language.”

请注意依据21CFR201.15进行标识时，允许采用英语和另一种语言进行双语标识。21CFR201.15如是说，“法规要求或药监要求的所有文字、声明和其它信息应以英文显示在标签或标示内容中”，并且“如果标签中有任何内容以外语呈现，则法规要求或药监要求的所有文字、声明和其它信息均应以该外语呈现在标签上。”

Conclusion结论

Violations cited in thisletter are not intended as an all-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。

On August 23, 2017, FDA placed your firm on Import Alert 66-40.

 2017年8月23日，FDA已将你公司放在了进口禁令66-40清单中。

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 adrug manufacturer.

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。

Failure to correct the seviolations may also result in FDA continuing to refuse admission of articles manufactured at Seindni Co., Ltd. at 610-304, 16, Gireum-ro, Seongbuk-gu, Seoulinto the 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 ofadmission, 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 the FD&C Act, 21 U.S.C. 351(a)(2)(B).

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 in writing within 15 working days. Specify what you havedone since our inspection to correct your violations and to prevent theirrecurrence. 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 [e-mail] mail your reply to:

Carlos M. González

Compliance Officer

U.S. Food and DrugAdministration

White Oak Building 51, Room4226

10903 New Hampshire Avenue

Silver Spring, MD 20993

USA

Please identify your responsewith FEI 3011476755.

Sincerely,

/S/ 

Francis Godwin

Acting Director

Office of ManufacturingQuality

Office of Compliance

Center for Drug Evaluation andResearch