FDA 483 - Jubilant Generics Limited - August 01, 2022

Jubilant Generics Limited in Sikanderpur Bhainswal, Uttaranchal, India, was inspected from July 20 to August 1, 2022, and received a Form 483 with six observations. The inspection revealed significant deficiencies in the firm's quality control unit, including failures to thoroughly investigate discrepancies, maintain adequate records for equipment failures and laboratory incidents, and follow established laboratory control mechanisms. Additionally, issues were noted with incomplete batch production and control records, leading to concerns about product quality and data integrity for products shipped to the US market.