FDA 483 - Dr. Reddy's Laboratories Limited (Unit II) - November 19, 2024
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.
An FDA inspection of Dr. Reddy's Laboratories Limited (Unit II) in Hyderabad, India, revealed significant deficiencies across multiple systems, including repeat observations for inadequate complaint investigations and computer system controls. The firm failed to maintain manufacturing processes in a validated state, exhibited poor quality control unit procedures, and lacked robust laboratory controls. These findings indicate a systemic failure to ensure the quality, purity, and compliance of Active Pharmaceutical Ingredients (APIs) destined for the US market.
ID · 270586ef-e74d-41e1-95e3-04a843954efa