483
Apotex Research Private LimitedFDA 483 - Apotex Research Private Limited
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 Apotex Research Private Limited in Bangalore, India, revealed significant deficiencies in manufacturing process validation, laboratory controls, and quality unit procedures. The firm failed to thoroughly investigate discrepancies, maintain equipment, and ensure proper documentation and tracking of materials and samples. Repeat observations were noted regarding control procedures and the stability testing program, indicating systemic issues.
- Product Type
- Drugs
Open in Dashboard
ID · e4899c56-8df1-4d9f-8486-9e68edd1627b