# FDA 483 - Vasudha Pharma Chem Limited - March 14, 2025

Source: https://www.globalkeysolutions.net/records/483/vasudha-pharma-chem-limited/4fdc2cfa-73fb-42a1-b9d7-1a11aa7b40b0

> FDA 483 for Vasudha Pharma Chem Limited on March 14, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Vasudha Pharma Chem Limited
- Inspection Date: 2025-03-14
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: The FDA inspection of Vasudha Pharma Chem Limited, Unit-I in Jeedimetla, Hyderabad, revealed significant deficiencies across multiple areas of their manufacturing operations. The firm failed to thoroughly investigate out-of-specification results and critical deviations, maintain adequate equipment cleaning, and ensure proper equipment qualification. Additionally, cleaning procedures lacked sufficient detail, and sampling plans for water were not scientifically sound, indicating systemic issues in their quality management system.

## Related Documents

- [483 - 2018-06-01](https://www.globalkeysolutions.net/records/483/vasudha-pharma-chem-limited/7a5e19fa-cf78-4ac1-81b1-f697c0328c3c)

## Related Officers

- [Lata C. Mathew](https://www.globalkeysolutions.net/people/lata-c-mathew/0610a0ef-dcc5-43e7-ab74-2ac54d758beb)

Company: https://www.globalkeysolutions.net/companies/vasudha-pharma-chem-limited/0811b896-55df-4e1d-b8f1-b2b3bb8b88a6

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