FDA 483 - Jubilant Generics Limited - August 01, 2025

Jubilant Generics Limited, a drug manufacturer in Roorkee, India, received a Form 483 with four observations during an FDA inspection. The firm was cited for issues including equipment not being of appropriate design, inadequate cleaning and maintenance of production equipment leading to contamination, and insufficient controls over computerized systems. Additionally, hold time studies were found deficient as product quantities used were not representative of actual batch sizes, with two observations being repeats from previous inspections.