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

Source: https://www.globalkeysolutions.net/records/483/pharmazell-india-private-ltd/251f3418-9bc4-45ff-b107-2c0ff8cf3692

> 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 Inspections and Investigations
- Summary: During an inspection from February 3-7, 2025, the FDA observed significant deficiencies at Pharmazell (India) Private Ltd, an API manufacturer in Visakhapatnam. The primary concern was the firm's failure to conduct proper installation, operation, and performance qualification studies for multiple pieces of manufacturing equipment. This indicates a lapse in ensuring equipment is fit for its intended use in producing active pharmaceutical ingredients.

## Related Documents

- [483 - 2025-02-07](https://www.globalkeysolutions.net/records/483/pharmazell-india-private-ltd/8d659770-e83f-4d55-b8b6-b42df7083d77)

## 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-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8