483
Alembic Pharmaceuticals LimitedFDA 483 - Alembic Pharmaceuticals Limited - March 24, 2023
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
Alembic Pharmaceuticals Limited in Vadodara, India, a sterile drug manufacturer, received a Form 483 with two observations. The inspection revealed inadequate quality control unit oversight regarding batch record review for drug product release and deficiencies in the internal audit system. These issues indicate a lack of robust quality management practices.
Open in Dashboard
ID · eddad71e-1e59-406b-931a-d1dd1cedbd0a