# FDA 483 - Mankind Pharma Limited - April 13, 2023

Source: https://www.keypedia.com/records/483/mankind-pharma-limited/c2dea6ae-5d46-45d5-a559-5eeccbc059de

> FDA 483 for Mankind Pharma Limited on April 13, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Mankind Pharma Limited
- Inspection Date: 2023-04-13
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Mankind Pharma Limited's Control Testing Laboratory in Gurugram, Haryana, India, revealed significant deficiencies in laboratory controls. The firm failed to conduct scientifically justified investigations for out-of-specification results and did not adequately qualify laboratory equipment and instruments for their intended use. These issues indicate a lack of robust quality control in their testing processes.

## Related Officers

- [Eileen A. Liu](https://www.keypedia.com/people/eileen-a-liu/fa051db4-1242-4181-9af9-5b3cd2de5689)

Company: https://www.keypedia.com/companies/mankind-pharma-limited/405cc26a-91d6-4d5c-b736-c878bb4298f9

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1