# FDA 483 - Naari Pharma Private Limited - June 07, 2022

Source: https://www.globalkeysolutions.net/records/483/naari-pharma-private-limited/9d1d8c9d-3400-403c-9bd7-96ae4fa8cd13

> FDA 483 for Naari Pharma Private Limited on June 07, 2022. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Naari Pharma Private Limited
- Inspection Date: 2022-06-07
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Naari Pharma Pvt. Ltd. in Rudrapur, India, revealed significant deficiencies in manufacturing practices. Observations included inadequate cleaning processes leading to residue on equipment, severe lack of controls over electronic data and audit trails, and failure to qualify critical packaging leak test apparatus. These issues indicate a concerning lack of control over drug product quality and data integrity.

## Related Documents

- [483 - 2023-01-27](https://www.globalkeysolutions.net/records/483/naari-pharma-private-limited/b1226a12-8c13-4255-acc0-e7fe11d0466d)
- [483 - 2025-11-01](https://www.globalkeysolutions.net/records/483/naari-pharma-private-limited/565d725a-cf78-45fe-ae79-ca23e1393577)

## Related Officers

- [Dipesh K. Shah](https://www.globalkeysolutions.net/people/dipesh-k-shah/d4df4040-13d1-477b-8c21-4c8e5b3fc5b9)

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

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