FDA对中国所有产品(包括无菌制剂、口服产品、原料药)进行飞检吗?根据什么原则决定飞检以及检查频率?
QA

Does FDA conduct surprise inspections on all Chinese products (including sterile products, oral products, and active pharmaceutical ingredients)? What principles determine surprise inspections and their frequency?

2025-07-16 16:19 识林-树苗     
1个回答

这个监管逻辑和国内飞检的监管逻辑应是一致的。

基于风险,基于企业历史合规情况。

2025-07-17 09:59 ggxwtt