FDA Inspection 640243 — Amigo Mobility International, Inc.
The FDA completed an inspection of Amigo Mobility International, Inc. on Jan 15, 2010 in Bridgeport, MI. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 9 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Jan 15, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Bridgeport, MI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 3118 | 21 CFR 820.75(a) | Documentation |
| 3160 | 21 CFR 820.184 | Lack of or inadequate DHR procedures |
| 3291 | 21 CFR 820.100(b) | Procedures |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 3665 | 21 CFR 820.20(b)(3) | Management representative |
| 3669 | 21 CFR 820.20(c) | Management review - defined interval, sufficient frequency |
| 4058 | 21 CFR 820.20 | Management responsibility |
| 4189 | 21 CFR 820.198(a) | General |