FDA 483 - Guangzhou Baiyunshan Jingxiutang Pharmaceutical Co. Ltd. - December 08, 2023

An FDA inspection of Guangzhou Baiyunshan Jingxiutang Pharmaceutical Co. Ltd., an OTC human drug manufacturer, revealed significant deficiencies in laboratory controls, including a repeat observation regarding active ingredient testing and inadequate microbial testing of the water system. Additionally, the firm failed to provide continuous GMP training to employees on US regulatory requirements, specifically 21 CFR Parts 210 and 211.