FDA 483 - Lupin Limited - November 23, 2022

The inspection at Lupin Limited Unit I in Mandideep, India, revealed significant deficiencies in quality control, data integrity, and manufacturing practices. Observations included inadequate investigations into out-of-specification results, lack of proper computer system controls, failure to maintain complete records, and deficiencies in engineering practices and equipment calibration. These issues indicate a systemic breakdown in ensuring the quality and integrity of pharmaceutical products.