# FDA 483 - Naari Pharma Private Limited - November 01, 2025

Source: https://www.globalkeysolutions.net/records/483/naari-pharma-private-limited/565d725a-cf78-45fe-ae79-ca23e1393577

> FDA 483 for Naari Pharma Private Limited on November 01, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Naari Pharma Private Limited
- Inspection Date: 2025-11-01
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Naari Pharma Private Limited, an Indian manufacturer of finished drug products, was inspected and received a Form 483 with four observations. The inspection revealed significant issues including an inadequate quality control unit, poor environmental monitoring and risk assessment for cross-contamination, facility design flaws leading to contamination, and insufficient investigations into environmental excursions and analytical discrepancies. These findings indicate a lack of robust quality systems and controls over manufacturing processes and laboratory operations.

## Related Documents

- [483 - 2022-06-07](https://www.globalkeysolutions.net/records/483/naari-pharma-private-limited/9d1d8c9d-3400-403c-9bd7-96ae4fa8cd13)
- [483 - 2023-01-27](https://www.globalkeysolutions.net/records/483/naari-pharma-private-limited/b1226a12-8c13-4255-acc0-e7fe11d0466d)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/rafeeq-a-habeeb/ac58c0b7-bd42-4037-8ccb-bf0351b7744f)

Company: https://www.globalkeysolutions.net/companies/naari-pharma-private-limited/1c2f99e8-3cb0-4ae1-ab3a-d3daf65f1595

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