对此，FDA并不接受，并声明：将处于“隔离”状态的成品药品进行发运是不允许的。在药品放行和分销之前，必须进行全放行检测，包括微生物检测。
翻译如下：
Release of Batch with Incomplete Finished Product Testing
放行未完成成品检测的批次
Your firm failed to establish an adequate quality unit (QU) to oversee the manufacture of your drug products. For example, your QU approved drug products for release without complete finished product testing. Your firm shipped a batch of(b)(4) to your customer on January 8, 2024; however, microbial testing for that batch was not received until January 10, 2024. Your QU approved the release of this batch, which stipulated all required test results for this batch were complete on December 24, 2023.
贵公司未能建立适当的质量部门（QU）来监督贵公司的药品生产。例如，你们的质量部门在未完成成品检验之前，就批准了药品的放行。贵公司于2024 年 1 月 8 日向你们的客户运送了一批（b）（4）;然而，直到 2024 年 1 月 10 日，才收到该批次的微生物检测结果。你们的质量部门批准了此批次的放行，而约定的批次所需的所有测试结果于2023 年 12 月 24日完成。
In your response, although you do not specifically indicate that batch of(b)(4) was shipped under quarantine, you provide your Quality Agreements and Shipping Addendums with your customers, which state that if you ship product “Under Quarantine,” your customers agree to hold the product in their “Quarantine” area until the final COA is received from your contract laboratory. You also state that if you ship product “Under Quarantine,” each pallet is appropriately labeled as such and communicated with each customer.
在你们的回复中，虽然你们没有具体说明该批次（b）（4）是在隔离条件下发货的，但你们提供了与客户的质量协议和运输附录，其中指出，如果你们发送的产品“处于隔离状态”，则你们的客户同意将产品保留在其“隔离”区域，直到收到合同实验室的最终COA。你们还声明，如果你们发送“隔离中”的产品，则每个托盘都会贴上适当的标签，并与每位客户进行沟通。
Your response is inadequate. It is not permissible to ship finished drug products “Under Quarantine” status. Full release testing, including microbial testing, must be performed before drug product release and distribution (21 CFR 211.165(a)).
你们的回复是不充分的。将处于“隔离中”状态的成品药品进行发运是不允许的。在药品放行和分销之前，必须进行全放行检测，包括微生物检测 （21 CFR 211.165（a））。