FDA 483 - Pucheng Chia Tai Biochemical Co. Ltd. - Putan Factory - April 18, 2025

Pucheng Chia Tai Biochemistry Co., Ltd., Putian Factory, an Active Pharmaceutical Ingredient manufacturer, was inspected by the FDA. The inspection revealed significant issues with the Quality Unit's oversight of stability data for APIs, specifically regarding moisture content and risk assessments. Additionally, the firm failed to establish adequate document retention procedures, leading to the loss of critical alarm history.