# FDA 483 - Mankind Pharma Limited - April 26, 2025

Source: https://www.globalkeysolutions.net/records/483/mankind-pharma-limited/6faf7c41-a0d5-40a4-8168-e26c65cf2bc3

> FDA 483 for Mankind Pharma Limited on April 26, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Mankind Pharma Limited
- Inspection Date: 2025-04-26
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: 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.

## Related Officers

- [Yvins Dezan](https://www.globalkeysolutions.net/people/yvins-dezan/e9fd12e6-c090-4eb6-bc78-8b80e8a90946)

Company: https://www.globalkeysolutions.net/companies/mankind-pharma-limited/0178beca-0473-4315-b2ce-0cb4d44da7ac

Office: https://www.globalkeysolutions.net/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8