FDA Inspection 836616 — Amigo Mobility International, Inc.
The FDA completed an inspection of Amigo Mobility International, Inc. on Jun 21, 2013 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). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 21, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Bridgeport, MI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3310 | 21 CFR 820.120(b) | DHR documentation of label release {see also 820.184} |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |