FDA 483 - Lupin Limited - March 29, 2023

Lupin Limited in Pithampur, India, received a Form 483 with 10 observations following an inspection from March 21-29, 2023. The observations highlight significant deficiencies in quality control, including inadequate investigations of OOS results and complaints, poor data integrity controls, and insufficient personnel training. The firm also failed to maintain proper environmental controls and sterility assurance for drug products.