FDA Inspection 966109 — Amigo Mobility International, Inc.
The FDA completed an inspection of Amigo Mobility International, Inc. on Mar 24, 2016 in Bridgeport, MI. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 24, 2016
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Bridgeport, MI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3149 | 21 CFR 820.180 | Availability |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 3669 | 21 CFR 820.20(c) | Management review - defined interval, sufficient frequency |
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |