FDA 483 - Chongqing Biocare Pharmaceutical Ltd. - September 22, 2023

An FDA inspection of Chongqing Biocare Pharmaceutical Ltd. in Chongqing, China, an API manufacturer, revealed issues with facility and equipment maintenance. Observations included improperly repaired and maintained surfaces in a clean area, loose insulation above manufacturing equipment, and a static electricity discharge device that had come loose from a warehouse wall. These conditions indicate a lack of proper control over the manufacturing environment and equipment.