FDA 483 - Vasudha Pharma Chem Limited - June 01, 2018

Vasudha Pharma Chem Limited, an API drug manufacturer in Hyderabad, India, was cited for deficiencies in its laboratory controls. The firm failed to establish scientifically sound and appropriate test procedures, specifically by not using a check standard solution in chromatographic analysis to confirm the potency, accuracy, and purity of working standard solutions for APIs distributed to the U.S. market. This indicates a significant concern regarding the quality assurance of their active pharmaceutical ingredients.