FDA 483 - Mankind Pharma Limited - April 26, 2025

The FDA Form 483 for Mankind Pharma Limited Sotanala details significant deficiencies across quality control, production, equipment maintenance, and warehouse management. Issues include inadequate investigation of out-of-specification results, lack of validation for recycled solvents, poor equipment cleaning and cross-contamination risks, and improper storage and commingling of APIs in warehouses. The firm also failed to maintain data integrity for computer systems and lacked proper laboratory controls and environmental monitoring.