FDA 483 - Amigo Mobility International, Inc - February 05, 2026

Amigo Mobility International, Inc. in Bridgeport, MI, a medical device manufacturer, was cited for multiple quality system deficiencies during an FDA inspection. The firm failed to adequately document risk management processes, implement corrective action procedures, and control nonconforming products. Additionally, issues were noted with personnel training, equipment calibration control, and the objectivity of internal audits, indicating significant gaps in their quality management system for Class II mobility scooters.