Vasudha Pharma Chem Limited - Unit IISeptember 13, 2024

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

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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.

Company: Vasudha Pharma Chem Limited - Unit II
Inspection Date: September 13, 2024
Product Type: Drugs
Office: Office of Inspections and Investigations
Person: Ankur C. Patel

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