FDA 483 - Aurobindo Pharma Limited - February 10, 2026

An FDA Form 483 was issued to Aurobindo Pharma Limited, Unit VII, detailing multiple deficiencies in their manufacturing and quality control processes. Observations included issues with equipment cleaning, computer system controls, master production records, complaint handling, and investigation of discrepancies. The report indicates a need for significant improvements in quality systems and adherence to CGMP requirements.