FDA警告信：菲律宾皮肤科学实验室

地球球长

July 28, 2017

Mr. Juan Pablo Bertotto

Chief Operating Officer

Skin Sciences Laboratory, Inc.

Unit 101 Central Business Park, Amang RodriguezAvenue, Manggahan

Pasig City, 1611 Philippines

Dear Mr. Bertotto:

The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Skin Sciences Laboratory Inc. at Unit 101Central Business Park, Amang Rodriguez Avenue, Manggahan Pasig City, from January 30 to February 1, 2017.

美国FDA于2017年1月30日至2月1日检查了你们位于菲律宾的制剂生产场所Skin Sciences实验室公司。

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21 U.S.C. 351(a)(2)(B)被认为是掺假药品。

The inspection also revealed that your firm manufactures and distributes unapproved new drugs in violation of section 505(a) of the FD&C Act, 21 U.S.C. 355(a). Additionally, FDA has determined that one of the drug products you manufacture is misbranded in violation of section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1).

检查还揭示出你们公司生产和销售了未经批准的新药，违反了FDCA第505(a)部分和21 U.S.C. 355(a)部分。另外，FDA已决定你们生产的药品之一为冒牌药，违反了FDCA第502(f)(1)部分和21 U.S.C.352(f)(1)部分。

We reviewed your February 16, 2017, response in detail and acknowledge receipt of your subsequent correspondence.

我们详细审核了你们公司2017年2月16日及之后的回复。

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：

CGMP Violations CGMP违规

1. Your firm does not have, 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(21 CFR 211.165(a)).

你公司在药品放行之前，没有适当的化验室检测并获得符合药品最终质量标准的结果，包括每种活性成分的鉴别和剂量（21 CFR211.165(a)）。

Your firm failed to test your (b)(4) products for identity and strength of active ingredients prior to release and distribution. We note that one of your (b)(4) drug products is labeled for application to (b)(4).

你们在放行和销售之前，没有检测XX产品中活性成分的鉴别和剂量。我们注意到你们的药品之一标签为适用于XX。

In your response, you stated that you would create a standard operating procedure which requires chemical analysis of active ingredients in your finished drug products prior to release. Your response is inadequate because you did not test your retain samples for all lots of drug product that you have distributed to the U.S. market without appropriate data to support their release.

在你们的回复中，你们导发我你们会制订标准操作程序，在其中要求在放行之前对制剂产品中的活性成分进行化学分析。你们的回复是不充分的，因为你们没有检测你们留样中的所有药品批次，这些批次已销售至美国市场，但没有适当的数据来支持其放行。

In response to this letter provide a detailed risk assessment for all drug products within expiry in the U.S. market and test all drug product retain samples for identity and strength of active ingredients.

在回复此函时，请为美国市场上仍在有效期内的所有药品提供详细的风险分析，检测所有药品留样中活性成分的鉴别和剂量。

2. Your firm failed to withhold from use each lot of components, drug product containers, and closures until the lot had been sampled, tested, or examined, as appropriate, and released for use by the quality control unit (21 CFR 211.84(a)).

你们公司未能由质量部门在使用每批成分、药品容器和密闭器之前进行取样、检测或检查，以及放行使用（适当时）（21 CFR 211.84(a)）。

Your firm failed to analyze glycerin raw material from your supplier to detect diethylene glycol (DEG) prior to the quality unit releasing the glycerin for use in drug product manufacturing. Glycerin is an ingredient in multiple drug products you manufacture, including Essence Skin Saving Toothpaste, an over-the-counter (OTC) drug product intended for oral use. DEG contamination has resulted in various lethal poisoning incidents in humans worldwide.

你公司未能分析你们供应商送来的甘油原料，在质量部门放行将之用于药品生产前检测二甘醇。甘油是你们生产的多个药品中的一种成分，包括精华护肤牙膏，这是一种口服OTC药品。DEG污染曾导致全球各种致命中毒事件。

In your response, you state you will implement testing to detect DEG in glycerin raw material lots. You also committed to testing any remaining glycerin stock material in your warehouse for DEG. Your response is inadequate because you did not test all lots of drug product that you distributed to the United States for DEG.

在你们的回复中，你们声称你们会执行检测以检出甘油原料批次中的DEG。你们还承诺要检测所有留存的甘油在库原料中的DEG。你们的回复是不充分的，因为你们没有检测所有销售至美国的药品批次中的DEG。

In response to this letter provide a detailed risk assessment for drug products that contain glycerin and are within expiry in the U.S. market. Also test retain samples of all lots for DEG.

在回复此函时，请提交详细的美国市场内仍在有效期内的药品中含有二甘醇的风险评估。还有检测所有批次留样中的DEG。

See FDA’s guidance document, Testing of Glycerin for Diethylene Glycol, to help you meet the CGMP requirements when manufacturing drugs containing glycerin, at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070347.pdf.

参见FDA指南，检测甘油中的二甘醇，以帮助你们生产含有甘油的药品时符合CGMP要求。

看到红字时，我想问：云南白药牙膏在国内是药品吗？（在美国估计要按OTC药品管理）

罗伊鲱

牙齿与口腔保健产品—关于OTC规章制定的回顾与展望
出处：《牙膏工业》 1995年 第1期 作者：杜启茹 罗伯特P·布莱迪

lhdfe

那可能不止云南白药牙膏了，六必治，冷酸灵之类的是不是也算了？还有中华出的草本牙膏估计也算。

syhorchid

了解一下