FDA 483 - Aurobindo Pharma USA Inc - May 15, 2024

Aurobindo Pharma USA Inc. in East Windsor, NJ, received a Form 483 following an inspection that identified significant deficiencies in its Drug Supply Chain Security Act (DSCSA) compliance systems. The firm failed to establish adequate procedures for identifying, investigating, and notifying authorities about suspect or illegitimate drug products. Additionally, the company did not report a cargo theft involving prescription drugs to the FDA within the required 24-hour timeframe.