FDA 483 - Visionary Medical Supplies Inc. - February 25, 2026

Visionary Medical Supplies Inc. in Madison, WI, a manufacturer of Class I and Class II medical devices, received a Form FDA 483 following an inspection. The inspection revealed significant deficiencies in the firm's quality management system, including a lack of timely management reviews and failure to establish and follow quality plans. These issues indicate a failure to maintain an effective quality system to ensure device safety and effectiveness.