# FDA 483 - Mankind Pharma Limited - March 25, 2025

Source: https://www.globalkeysolutions.net/records/483/mankind-pharma-limited/6b147711-ca8a-45f3-9c86-5404652bdb59

> FDA 483 for Mankind Pharma Limited on March 25, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Mankind Pharma Limited
- Inspection Date: 2025-03-25
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Mankind Pharma Limited in Paonta Sahib, India, was inspected by the FDA, resulting in three observations. The inspection revealed deficiencies in equipment cleaning and maintenance procedures, inadequate equipment design and operational procedures for decontamination, and scientifically unsound sampling plans for stability studies. These issues indicate a lack of robust controls to ensure drug product quality and purity.

## Related Documents

- [483 - 2019-01-11](https://www.globalkeysolutions.net/records/483/mankind-pharma-limited/35bc6b3c-661d-4936-b769-15ade70a402f)
- [483 - 2022-02-25](https://www.globalkeysolutions.net/records/483/mankind-pharma-limited/752e8a8d-8ce6-4e99-adcd-e9576843a609)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/unnee-ranjan/43f1d07e-4079-4d33-88a9-baf6a5df932c)

Company: https://www.globalkeysolutions.net/companies/mankind-pharma-limited/448ddf49-4ff4-4a2b-8444-e8cc23677777

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