# FDA 483 - Mankind Pharma Limited - January 11, 2019

Source: https://www.globalkeysolutions.net/records/483/mankind-pharma-limited/35bc6b3c-661d-4936-b769-15ade70a402f

> FDA 483 for Mankind Pharma Limited on January 11, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Mankind Pharma Limited
- Inspection Date: 2019-01-11
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Mankind Pharma Limited in Rampur Ghat, Himachal Pradesh, India, revealed a significant issue with the facility's plumbing system. The firm failed to detect leaks from its (b) (4) system, which could lead to contamination of drug products. This observation indicates a potential risk to product quality and patient safety.

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## Related Officers

- [Santos E. Camara](https://www.globalkeysolutions.net/people/santos-e-camara/18cea942-f6f9-4dec-9ce9-1c01c39009ce)

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

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd