FDA 483 - Aurobindo Pharma Limited - September 29, 2023

Aurobindo Pharma Limited, Unit-VI in Polepaur, India, a sterile and non-sterile drug manufacturer, was inspected by the FDA from September 22-29, 2023. The inspection revealed a failure to establish adequate control procedures for manufacturing processes, specifically concerning the monitoring of packaging hold times. The firm's Quality Unit did not implement comprehensive corrective and preventive actions to address 35 batches that exceeded established hold times, a deficiency noted as a repeat observation from a previous inspection.