FDA 483 - Aurobindo Pharma Limited - February 17, 2020

An FDA inspection of Aurobindo Pharma Ltd in Bachupally, Telangana, revealed significant deficiencies in their manufacturing operations. Observations included inadequate facilities and procedures to prevent contamination of sterile drug products, insufficient employee training, and a failure to thoroughly investigate discrepancies and out-of-specification results. The firm also demonstrated inadequate procedures for handling product complaints and validating test methods.