# FDA 483 - Pharmazell (India) Private Ltd - February 07, 2025

Source: https://www.globalkeysolutions.net/records/483/pharmazell-india-private-ltd/8d659770-e83f-4d55-b8b6-b42df7083d77

> FDA 483 for Pharmazell (India) Private Ltd on February 07, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pharmazell (India) Private Ltd
- Inspection Date: 2025-02-07
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Pharmazell (India) Private Ltd's API manufacturing facility in Visakhapatnam revealed significant deficiencies in equipment qualification. The firm failed to conduct proper installation, operational, and performance qualification studies for multiple manufacturing equipment. This indicates a lack of adherence to a written program designed to assure proper equipment performance.

## Related Documents

- [483 - 2025-02-07](https://www.globalkeysolutions.net/records/483/pharmazell-india-private-ltd/251f3418-9bc4-45ff-b107-2c0ff8cf3692)

## Related Officers

- [Olumide A. Akinyemi](https://www.globalkeysolutions.net/people/olumide-a-akinyemi/a520acd2-450c-4624-a7af-b871e4fad9c7)
- [Drug Investigator](https://www.globalkeysolutions.net/people/jessica-s-estriplet/b7152ec3-6e1b-45aa-840e-7147f357aea2)

Company: https://www.globalkeysolutions.net/companies/pharmazell-india-private-ltd/1a60e2bc-b058-468d-b52f-ba85d9f757d2

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