转载：FDA警告信：Barox Co., Ltd. 20181128

北重楼

Warning Letter 320-19-03

November 28, 2018

Mr. Hak-Ki Kim, President, Barox Co., Ltd.

Number 706, Halla Sigma, 545, Dunchon-Daero

Jungwon-gu, Gyeonggi-do, Seongnam, 13215, REPUBLIC OF KOREA

Dear Mr. Kim:

The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Barox Co., Ltd. at Number 706,Halla Sigma, 545, Dunchon-Daero, Jungwon-gu, Gyeonggi-do, Seongnam, from May 17to 18, 2018.

美国FDA于2018年5月17-18日检查了你们位于韩国城南市的Barox 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。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21U.S.C. 351(a)(2)(B)被认为是掺假药品。

We reviewed your June 7, 2018, response in detailand acknowledge receipt of your subsequent correspondence. Your response is inadequate because it did not provide sufficient evidence of corrective actionsto bring your operations into compliance with CGMP.

我们详细审核了你们2018年6月7日的回复，并此告知已收悉你公司后续回复。你们的回复是不充分的，因为它未提供足够证据证明纠正措施会使得你们的操作符合CGMP要求。

During our inspection, our investigator 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 establish written responsibilities and procedures applicable to the quality control unit (21 CFR 211.22(d)). 你公司未建立质量部门书面职责和程序（21 CFR 211.22(d)）。

Your firm relabels over-the-counter (OTC) drug products made for you by a contract manufacturer. You then distribute these drug products to the United States. You have no written documents describing roles and responsibilities of a Quality Control Unit (QCU). All of your employees, including those in the QCU, lack knowledge of CGMP requirements.

你公司对你们委托生产商生产的OTC药品重新贴标，然后销售至美国。你们没有书面文件描述质量部门的职责。你们所有员工，包括质量部门的员工均缺乏CGMP要求知识。

Your response states, "These procedures will be reviewed and approved by the quality unit as below," and the remainderof the document contained 21 CFR part 211 citations quoted verbatim. Your response failed to provide:

你们回复声称“这些程序将按如下流程由质量部门审批”，然后文件里剩下的部分一字不差地引用了21CFR第211部分内容。你们的回复未提交：

A detailed description of the responsibilities of your QCU.

对你们QCU职责的详细描述

Evidence that you have established appropriate written procedures for QCU functions.

你们已为QCU部门建立适当的书面程序的证据

Evidence that your personnel are appropriately trained to perform their assigned function.

你们的人员经过适当培训可履行其指定职责的证据

2.     Your firm failed to exercise strict control over labeling issued for use in drug product labeling operations (21 CFR 211.125(a)). 你公司未能对药品贴标操作所用未进行严格控制（21 CFR 211.125(a)）。

You have no procedures for relabeling operations, including issuance or reconciliation of labels. You relabel at least (b)(4) drug products, including (b)(4) for the U.S. market, without proper labeling controls to prevent labeling mix ups.

你们的重新贴标操作没有程序，包括标签发放和衡算。你们对至少XX药品进行了重新贴标，包括美国市场的XX，但没有适当的贴标控制以防止标签混淆。

Your response failed to provide written procedures for labeling operations performed at your facility. You failed to ensure that relabeling occurs under appropriate CGMP controls.

你们的回复未能提供你们工厂实施贴标的书面程序。你们未能确保在适当CGMP控制下进行重新贴标操作。

3.     Your firm failed to establish and follow written procedures regarding storage and warehousing of drug products (21 CFR 211.142). 你公司未建立和遵守书面的药品存贮和仓管程序（21 CFR 211.142）。

You have no procedures for storage and warehousing of drug products, including quarantine storage before release of drug products.

你们没有药品存贮和仓管程序，包括药品放行之前的隔离存贮。

Your response failed to provide written procedures for storage and warehousing. Holding of drug products must be performed under appropriate CGMP controls.

你们的回复未提供书面存贮和仓管程序。药品保存必须在适当CGMP控制下执行。

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 qualifiedas set forth in 21 CFR 211.34, 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 fully resolving all deficiencies and ensuring ongoing CGMP compliance.

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 CFR 211.34所述资质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。

Owner’s responsibilities 所有人职责

Drugs must be manufactured in conformance with 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.

药品生产必须符合CGMP要求。FDA了解许多药品生产商会使用独立的合同商，如生产场所、检验化验室、包装商和贴标商。FDA将合同商视为生产商的延伸。

You are responsible for the quality of drugs youproduce, regardless of agreements in place with your contract facility. You arerequired 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 athttps://www.fda.gov/downloads/Dr ... nces/UCM353925.pdf.

无论你们与合同场所之间是否签有协议，你们都对你们生产的药品质量负有责任。你们要确保药品生产符合FDCA第501(a)(2)(B)部分要求，确保其安全性、鉴别、剂量、质量与纯度。参见FDA指导文件“药品合同生产安排：质量协议”。

Conclusion 结论

Violations cited in this letter 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。

FDA placed your firm on Import Alert 66-40 on November 8, 2018.

FDA已于2018年11月8日将你公司放入进口禁令清单66-40项下。

Until you correct all violations completely and weconfirm your compliance with CGMP, FDA may withhold approval of any newapplications or supplements listing your firm as a drug 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 these violations may also resultin FDA continuing to refuse admission of articles manufactured at Barox Co.,Ltd. at Number 706, HallaSigma, 545, Dunchon-Daero, Jungwon-gu, Gyeonggi-do,Seongnam, into 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 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 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 thisoffice in writing 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:

           Lynnsey Renn, Ph.D.

           Compliance Officer

           U.S. Food and Drug Administration

           White Oak Building 51, Room 4359

10903 New Hampshire Avenue

           Silver Spring, MD  20993

           USA

Please identify your response with FEI 3010166805.

Sincerely,

/S/                                          
Francis Godwin

ActingDirector                                                                                                                                 

Office of Manufacturing Quality

Office of Compliance

Center for Drug Evaluation and Research

xqliu

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21U.S.C. 351(a)(2)(B)被认为是掺假药品。
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 CFR 211.34所述资质的顾问来协助你们公司符合CGMP要求。

胜利者

路过

syhorchid

了解一下

小金库

非常感谢分享