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

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.