FDA 483 - AUSA MEDICAL DEVICES PVT LTD - March 05, 2026

An FDA inspection of AUSA MEDICAL DEVICES PVT LTD in Bengaluru, India, a contract manufacturer, revealed significant deficiencies in its quality management system. The firm failed to adequately address recurring nonconformities, maintain effective risk management processes, and control essential quality records. These issues indicate a lack of robust controls over manufacturing processes and documentation.