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.
ID · 6faf7c41-a0d5-40a4-8168-e26c65cf2bc3
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