FDA 483 - Mankind Pharma Limited - February 25, 2022

Mankind Pharma Limited received a Form 483 citing significant deficiencies in its manufacturing operations. Observations included inadequate equipment design and qualification for filter integrity testing, insufficient cleaning and sanitization of equipment leading to residue, and critical failures in maintaining aseptic processing areas through proper cleaning, disinfection, and environmental monitoring. Additionally, the firm demonstrated inadequate investigation of discrepancies and lacked robust written procedures for process controls.