FDA 483 - Amphastar Nanjing Pharmaceuticals Inc - October 10, 2019

An FDA inspection of Amphastar Nanjing Pharmaceuticals, Inc. in Nanjing, China, revealed a deficiency in their annual visual inspection of retention samples. The firm's procedure and practice only included inspection of packaging, labeling, location, and quantity, but not the product itself. The company initiated corrective action during the inspection by updating their SOP to include product inspection.