# FDA 483 - Naari Pharma Private Limited - January 27, 2023

Source: https://www.globalkeysolutions.net/records/483/naari-pharma-private-limited/b1226a12-8c13-4255-acc0-e7fe11d0466d

> FDA 483 for Naari Pharma Private Limited on January 27, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Naari Pharma Private Limited
- Inspection Date: 2023-01-27
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Nasri Pharma Private Limited, a drug product manufacturer, was cited for significant deficiencies in its production and process controls. Observations included failures to record deviations in process validation reports and a lack of adequate written procedures to ensure drug product quality, purity, and strength. The firm also exhibited issues with following SOPs, inconsistent batch record entries, and inadequate investigations into out-of-specification results.

## Related Documents

- [483 - 2022-06-07](https://www.globalkeysolutions.net/records/483/naari-pharma-private-limited/9d1d8c9d-3400-403c-9bd7-96ae4fa8cd13)
- [483 - 2025-11-01](https://www.globalkeysolutions.net/records/483/naari-pharma-private-limited/565d725a-cf78-45fe-ae79-ca23e1393577)

## Related Officers

- [Jogy George](https://www.globalkeysolutions.net/people/jogy-george/00ef0915-66d2-4b34-9b74-d1e08caf2db3)

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
