FDA 483 - Lupin Limited - April 04, 2022

An FDA inspection of Lupin Limited in Palghar, India, an API manufacturer, identified critical deficiencies in manufacturing processes, cleaning validation, in-process controls, and quality unit investigations. The firm failed to prevent contamination and cross-contamination of APIs, particularly with genotoxic impurities, due to the use of non-dedicated equipment and solvent recovery systems without adequate testing or cleaning validation. These systemic issues indicate a significant risk to the quality and safety of drug products intended for the US market.