FDA 483 - Lupin Limited

Lupin Limited in Nagpur, India, received a Form FDA 483 with five observations following an inspection on October 20, 2022. The inspection revealed significant deficiencies in aseptic processing areas, including facility surfaces, microbiological contamination prevention procedures, inadequate validation of aseptic processes, and environmental monitoring systems. Additionally, the firm failed to thoroughly review unexplained discrepancies and out-of-specification events related to API shipment and sterility testing.