FDA 483 - Symbiotec Pharmalab Limited - September 30, 2022

An FDA inspection of Symbiotec Pharmalab Pvt. Limited, an API manufacturer in Pithampur, India, revealed significant deficiencies across six observations. The firm failed to follow laboratory control procedures, adequately validate cleaning processes for non-dedicated equipment, and establish proper monitoring for processing steps. Additionally, the inspection found issues with the investigation of computerized system errors, the review of analytical method validation documents, and the timely resolution of quality complaints.