FDA 483 - Dane Technologies - August 25, 2025

An FDA inspection of Dane Technologies in Maple Grove, MN, a manufacturer of the Wheel Chair Mover device, revealed significant deficiencies in its quality system. The firm failed to adequately establish corrective and preventive action procedures, servicing procedures, and did not conduct management reviews or quality audits with sufficient frequency. These issues indicate a systemic breakdown in maintaining an effective quality management system.