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

Source: https://www.keypedia.com/records/483/amigo-mobility-international-inc/aef2ad09-f2cb-46e0-ac79-456be2896afa

> FDA 483 for Amigo Mobility International, Inc on February 05, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Amigo Mobility International, Inc
- Inspection Date: 2026-02-05
- Product Type: device
- Office Name: Detroit District Office
- Summary: 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.

## Related Officers

- [David J. Gasparovich](https://www.keypedia.com/people/david-j-gasparovich/478888db-d4b3-481a-89f5-ee234a160f07)

Company: https://www.keypedia.com/companies/amigo-mobility-international-inc/0a24d9d1-ee49-480f-bf2a-1b8ba485d392

Office: https://www.keypedia.com/offices/detroit-district-office/b09a1815-a000-40c0-bb44-5432ce87ed03