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

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.