FDA 483 - Chongqing Daxin Pharmaceutical Co., Ltd.

An FDA inspection of Chongqing Daxin Pharmaceutical Co., Ltd. in Chongqing, China, revealed two significant issues. The firm failed to follow written procedures for cleaning equipment used in API manufacturing, as evidenced by visually unclean equipment marked as "Cleaned." Additionally, there was a lack of temperature monitoring instruments in rooms used for the packaging process of APIs, which is critical for maintaining product storage conditions.