FDA 483 - Lupin Limited - November 21, 2025

Lupin Limited, a drug product manufacturer in Verna, Goa, India, was cited with seven observations during an FDA inspection from November 10-21, 2025. Key issues include the quality unit's failure to address drug products exceeding impurity limits, unreliable analytical test methods, inadequate cleaning validation, and deficient investigations into OOS results and customer complaints. These findings indicate significant concerns regarding product quality control, data integrity, and overall adherence to cGMP regulations.