FDA警告信：武汉简德明康

一片红云

来源：GMP办公室  （ 翻译组）


2017年03月14日，FDA官网挂出对湖北武汉简德明康药业有限公司的警告信，根据该警告信，简德明康药业有限公司涉嫌冒牌销售、复制粘贴其他公司的分析结果作为自己的检验报告书、销售被列入FDA进口警报的供应商的药品等缺陷。具体如下：

The U.S. Food and Drug Administration (FDA)inspected your drug manufacturing facility, Lumis Global Pharmaceuticals Co.Ltd. at Unit 305 Huishang Mansion Building A, 2 Wudayuan Road Donghu New Technology Development Zone, Wuhan, from September 26 to 28, 2016.
美国FDA于2016于9月26-28日检查了贵公司位于武汉市东湖新技术开发区武大园路2号徽商大厦A-305的药品生产场所简德明康药业（武汉）有限公司。

This warning letter summarizes significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (API).
本警告信概述了不符合原料药（API）CGMP要求的严重违规情况。

Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your API 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).
由于你们生产、加工、包装和存贮药品的方法、设施和控制不符合CGMP，根据FDAC501(a)(2)(B)和21U.S.C. 351(a)(2)(B) ，你们的药品被认为是掺假药。

In addition, your gabapentin API is misbranded undersections 502(a) and 502(b)(1) of the FD&C Act, 21 U.S.C. 352(a) and352(b)(1).
另外，你们的加巴喷丁原料药根据FDCA的502(a)和 502(b)(1) 部分和 21 U.S.C. 352(a)和352(b)(1)部分认定为冒牌药。

We reviewed your November 9, 2016, response in detail. We note your response addressed some FDA observations, but did not address the issues noted below.
我们详细审核了你们于2016年11月9日所发的回复。我们注意到你们回复中解决了一些FDA发现的缺陷，但并没有解决以下问题：

During our inspection, our investigator observed specific deviations including, but not limited to, the following.
在我们检查期间，我们的调查人员发现具体违规情况包括但不仅限于以下：

CGMP Deviations
CGMP问题

1.      Failure to transfer all quality or regulatory information received from the API manufacturer to your customers.
未能将所有从API生产商处收到的法规信息和质量信息转达给你们客户。

You omitted the name and address of the original API manufacturers on the certificates of analysis (COA) you issued to your customers, and did not include copies of the original batch certificate.
你们在你们签发给客户的检验报告书（COA）上没有写上原始API生产商的名称和地址，也没有附上原始的批检验报告副本。

For multiple API, you generated COA by copying and pasting analytical results from the original API manufacturers, replacing the manufacturers’ information with your letterhead, then issuing these COA to your customers. You omitted critical information, including the original manufacturers’ names and addresses and the names, addresses, and telephone numbers of laboratories that performed the testing.
你们通过复制粘贴原始API生产商分析结果的方式制作了多个API的COA，用你们的信笺抬头替换掉了生产商的信息，然后将这些COA签发给你们的客户。你们没有写上关键信息，包括原始生产商的名称和地址、实施该检验的化验室的名称、地址和电话号码。

Customers and regulators rely on COA for information about the quality and sourcing of drugs and their components. Omitting information from COA compromises supply-chain accountability and traceability, and may put consumers at risk.
客户和法规人员依赖于COA来获取药品及其成分的质量和来源信息。在COA上不提供这些信息使得供应链可靠信和可追溯性受到损害，可能会将客户置于风险之下。

2.      Failure to control the API repackaging, relabeling, and holding operations in order to avoid mix ups and loss of API identity.
未能控制API重新包装、重新标签和存贮操作以避免混淆和API识别性缺失。

Our FDA investigator documented unlabeled material in your “released for shipping” area. You told the investigator that this material was not to be released to customers, but was in fact intended for destruction.
我们的FDA检查人员记录下了在你们“发货放行”区的无标签的物料。你们告诉检查人员说该物料并不是要放行给客户，而是要进行销毁的。

To avoid mix-ups between materials that can and cannot be released, or between different API, you must repackage, relabel, and hold API under appropriate CGMP controls.
为了避免混淆可以放行和不可以放行的物料，避免混淆不同API，你们必须在恰当的CGMP控制下重新包装、重新标签以及存贮API。

Misbranding Violations
冒牌行为

The gabapentin API labels bear the statement “Manufactured under cGMP conditions by: Lumis Global Pharmaceuticals Co., Ltd.” This statement is misleading because it indicates that the manufacturer of the API is Lumis Global Pharmaceuticals Co., Ltd. instead of (b)(4). Therefore, the gabapentin APIs is misbranded under section 502(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) in that the API labeling is misleading.
加巴喷丁原料药标签带有这样的声明：“由简德明康药业(武汉)有限公司在CGMP条件下生产”。该声明是误导性的，因为它标示生产商是简德明康药业(武汉)有限公司而不是XX。 因此，该加巴喷丁原料药根据《联邦食品、药品和化妆品法案（FD&CA）》第502（a）章节规定，因其标签带有误导性，是冒牌的。

In addition, section 502(b)(1) of the FD&C Act requires a drug to contain the name and place of business of the manufacturer, packer, or distributor of the drug. The label of Lumis’ API product is misbranded under section 502(b)(1) because it misidentifies Lumis, which is a distributor or packer, as the manufacturer. As evidenced by the certificates of analysis, (b)(4) is the manufacturer of the gabapentin API, not Lumis Global Pharmaceuticals Co. Ltd.
另外， FD&CA第502（b）（1）章节要求药品包含有生产商、分包商和分销商的名字、地址。简德明康的原料药根据章节502（b）（1）是冒牌的，因为它把分销商或者分包商，简德明康，标成生产商。由检验报告书可以证明，XX才是加巴喷丁的生产商，而不是简德明康药业（武汉）有限公司。

Shipping drugs from a manufacturer on FDA Import Alert 66-66
销售被列入FDA进口警报66-66的生产商的药品

(b)(4), one of your suppliers, has been on Import Alert 66-66 since (b)(4), specifically for their (b)(4) USP API. However, you shipped (b)(4) USP API manufactured by this firm to the United States in February 2015 and declared that you were the manufacturer on importation documents.
你们的一个供应商，XX，从XX开始已经被列入进口警报66-66，特别是他们的XX USP原料药。然而，你们于2015年2月份销售该公司生产的XX USP原料药到美国，并在进口文件中声称你们就是生产商。

紫幻剑雨888

牛人天天有……只是你未见。时代变了。。。。

伊娃瓦力

你们通过复制粘贴原始API生产商分析结果的方式制作了多个API的COA，用你们的信笺抬头替换掉了生产商的信息，然后将这些COA签发给你们的客户。你们没有写上关键信息，包括原始生产商的名称和地址、实施该检验的化验室的名称、地址和电话号码。---------这是要干嘛？

zysx01234

伊娃瓦力 发表于 2017-4-24 08:14
你们通过复制粘贴原始API生产商分析结果的方式制作了多个API的COA，用你们的信笺抬头替换掉了生产商的信息 ...

就是贸易商，代理商，无法无天的那种，只要有客户，什么都敢干

伊娃瓦力

zysx01234 发表于 2017-4-24 08:31
就是贸易商，代理商，无法无天的那种，只要有客户，什么都敢干

我也是这么想的

xqliu

以前有很多这样的做法。

一片红云

xqliu 发表于 2017-4-24 11:05
以前有很多这样的做法。

现在也不少，利益驱动