Amigo Mobility International, Inc – FDA 483, Feb 5, 2026

Amigo Mobility International, Inc. in Bridgeport, MI, was inspected regarding its medical device manufacturing operations. The FDA issued a Form 483 citing six observations related to significant deficiencies in the firm's quality system, including inadequate risk management, ineffective corrective and preventive actions, and failures in nonconforming product control, training, equipment calibration, and internal audit objectivity. These issues indicate a lack of robust quality system controls for their Class II Amigo Mobility Scooters.