FDA Inspection 1301792 — Amigo Mobility International, Inc.
The FDA completed an inspection of Amigo Mobility International, Inc. on February 5, 2026 in Bridgeport, MI. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- February 5, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Bridgeport, MI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23070 | ISO 13485:2016 Clause 6.2 | Process(es) for personnel competence, training and awareness not documented |
| 23087 | ISO 13485:2016 Clause 7.1 | Product realization risk management processes not documented |
| 23193 | ISO 13485:2016 Clause 7.6 | Procedures for monitoring and measuring equipment requirements not documented |
| 23224 | ISO 13485:2016 Clause 8.2.4 | Objectivity and impartiality of internal audit process not ensured |
| 23238 | ISO 13485:2016 Clause 8.3.1 | Nonconforming product not adequately evaluated |
| 23258 | ISO 13485:2016 Clause 8.5.2 | Corrective action procedures not documented |