FDA 483 - Optimus Pharma Private Limited - December 11, 2025

Optimus Pharma Private Limited in Sangareddy, India, was cited for significant deficiencies in its drug manufacturing operations. The inspection revealed issues with equipment cleaning validation, annual reserve sample inspections, quality unit procedures for vendor qualification, investigation of discrepancies, and data backup for critical systems. These findings indicate a lack of robust quality control and adherence to cGMP regulations.