FDA 483 - Shanghai Chuangshi Medical Technology (Group) Co., Ltd. - September 13, 2024

An FDA inspection of Shanghai Chuangshi Medical Technology (Group) Co., Ltd., an OTC human drug manufacturer in Qingpu District, Shanghai, China, revealed significant deficiencies in quality control. Observations included an inadequate stability program lacking impurity testing and stability-indicating methods, failure to perform identity testing for drug product components, and insufficient procedures to prevent objectionable microorganisms. These issues indicate a lack of assurance regarding drug product quality and safety.