FDA 483 - Jiangsu Intco Medical Products Co., Ltd. - November 17, 2023

Jiangsu Intco Medical Products Co., Ltd., an OTC drug manufacturer in Zhenjiang, China, was cited for significant deficiencies during an FDA inspection. The observations primarily concern inadequate production and process controls, including failure to retain process validation records and maintain a robust stability testing program. Additionally, the firm was cited for insufficient drug product component testing and a deficient supplier qualification program.