FDA 483 - Aurobindo Pharma Limited - September 29, 2023

Aurobindo Pharma Limited, Unit-VI in Penapur, India, was inspected from September 22-29, 2023, and received one observation. The firm failed to establish adequate control procedures to monitor manufacturing processes, specifically regarding the management of packaging hold times. This is a repeat observation, indicating a persistent issue with ensuring product quality and process control.