FDA 483 - Aurobindo Pharma Limited - September 27, 2019

Aurobindo Pharma Limited, a finished product manufacturer in Polepally, India, was cited for significant deficiencies across its quality system. Observations included failures in out-of-specification (OOS) investigations, lack of adequate written procedures for production and process controls, and incomplete laboratory records. These issues indicate a systemic breakdown in ensuring drug product quality, identity, strength, and purity.