FDA 483 - Aurobindo Pharma Limited - September 05, 2025

An FDA inspection of Aurobindo Pharma Ltd. in Bachupally, Hyderabad, revealed critical deficiencies in sterile drug product manufacturing, including inadequate aseptic processing and environmental monitoring. The firm also failed to properly investigate product complaints and batch discrepancies, and exhibited issues with process validation, equipment cleaning, and facility maintenance. These observations indicate significant non-compliance with cGMP regulations across multiple operational areas.