COA不正确引发的FDA警告信

FDA Warning Letter due to incorrect Certificates of AnalysisCOA不正确引发的FDA警告信

This FDA's Warning Letter to the Chinese manufacturer Lumis Global Pharmaceuticals on 2 March 2017 is based on FDA inspections in September 2016.

FDA于2017年3月2日发给中国生产商LUMIS的警告信是源于2016年9月的检查。

Specifically, the certificates of analysis (certificates of analysis, COA) were criticized. The issued certificates did not contain all relevant information on the quality that would have been necessary for the customer.

具体来说，COA受到了批评。该公司所签发的COA未包括所有相关的质量信息，而这些是客户所必须的。

The FDA Warning Letter states:

FDA的警告信说：

"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.

你们在你们签发给你们客户的COA中略去了原始API生产商的名称和地址，并且没有包括原始批次证书的副本。

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.

通过复制粘贴原始API生产商的分析结果，你们制作了多个API的COA，用你们的信头替代了生产商的信息，然后将这些COA签发给你们客户。你们略去了关键信息，包括原始生产商的名称和地址，实施检测的化验室的名称、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."

客户和法规监管方依赖于COA获取质量及药品和组分的质量信息。在COA上略去这些信息使得供应链可靠信和可追溯性受损，可能会将消费者置于风险中。

You can find the details in the complete FDA Warning Letter an Lumis Global Pharmaceuticals.

在上述链接中可以找到警告信全文。