FDA 483 - Ipca Laboratories Limited - October 17, 2014

An FDA inspection of Ipca Laboratories Ltd in Pithampur, India, revealed significant data integrity and quality control deficiencies. The firm was observed performing unreported "trial" injections to achieve passing results, deleting and overwriting raw electronic data, and lacking proper computer system controls. Additionally, the inspection found inadequate deviation investigations, uncontrolled quality unit stamps, and failures in employee training documentation.