FDA 483 - SHANTOU S.E.Z BAOJIE INDUSTRY CO., LTD - August 30, 2024

Shantou S.E.Z Baojie Industry Co., Ltd, an OTC drug product manufacturer in Shantou, China, was cited for significant deficiencies in its quality control and manufacturing processes. Observations included failure to test components, verify identity of ingredients, qualify equipment, maintain a proper stability program, retain reserve samples, validate test methods, provide batch records, and establish annual quality evaluations. These issues indicate a severe lack of adherence to good manufacturing practices, potentially impacting the safety, quality, and efficacy of drug products distributed to the US market.