FDA 483 - Aurobindo Pharma Limited - February 21, 2020

An FDA inspection of Aurobindo Pharma Ltd in Bachupally, Telangana, revealed significant deficiencies in manufacturing practices for drug products. Observations included inadequate facilities for contamination prevention, failures in microbiological contamination control for sterile products, and insufficient employee training. The firm also demonstrated poor handling of discrepancies, out-of-specification results, and customer complaints, alongside unvalidated test methods.