# FDA 483 - Vasudha Pharma Chem Limited - Unit II - September 13, 2024

Source: https://www.keypedia.com/records/483/vasudha-pharma-chem-limited-unit-ii/1712cb49-6b41-4ebf-8a95-1c45368a54af

> FDA 483 for Vasudha Pharma Chem Limited - Unit II on September 13, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Vasudha Pharma Chem Limited - Unit II
- Inspection Date: 2024-09-13
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Vasudha Pharma Chem Limited - Unit II, an API Non-Sterile Drug Substance Manufacturer in Thanam, India, was inspected by the FDA from September 9-13, 2024. The inspection revealed inadequate control over computer systems used for drug substance analysis. Specifically, the firm lacked procedures to prevent unauthorized aborting or stopping of sample sets during HPLC/GC analysis, which was observed in audit trails.

## Related Officers

- [Ankur C. Patel](https://www.keypedia.com/people/ankur-c-patel/602c7d14-2c48-4929-a07b-6e4c235d7f13)

Company: https://www.keypedia.com/companies/vasudha-pharma-chem-limited-unit-ii/adc525bc-9a23-4664-bc09-ca04b55f8173

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