Virtual Radiologic Corp. – FDA 483, Mar 5, 2026

An FDA inspection of Virtual Radiologic Corporation in Edina, MN, revealed significant deficiencies in their quality management system. The firm failed to implement adequate corrective actions for a class II medical device software issue, lacked sufficient resources for QMS maintenance, and had inadequate procedures for supplier control and personnel training. These observations indicate a systemic breakdown in maintaining a compliant quality system for their medical imaging products.