FDA 483 - Jubilant Generics Limited - August 01, 2025

An FDA inspection of Jubilant Generics Limited in Roorkee, India, revealed significant deficiencies in equipment design, cleaning, data integrity, and process control. The firm failed to demonstrate that production equipment was suitable for its intended use and free from contamination, and lacked appropriate controls over computerized systems. Additionally, hold time studies were found to be deficient, using unrepresentative product quantities.