FDA 483 - Lupin Limited - April 07, 2017

An FDA inspection of Lupin Limited in Verna, India, revealed significant deficiencies across its quality control, production, and process control systems. The firm failed to thoroughly investigate out-of-specification results, often invalidating them without scientific justification or adequate corrective actions. Additionally, the inspection found inadequate procedures for hold time studies, process validation, and monitoring of manufacturing processes, including issues with data integrity in in-process testing.