483
Amphastar Nanjing Pharmaceuticals IncFDA 483 - Amphastar Nanjing Pharmaceuticals Inc - October 10, 2019
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
Record Details
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.
Open in Dashboard
ID · 1b722d28-3603-4fae-a123-76b1bd4c8cb7