FDA Inspection 1074131 — Allied Vision Group Inc
The FDA completed an inspection of Allied Vision Group Inc on December 11, 2018 in Fort Lauderdale, FL. 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
- December 11, 2018
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Fort Lauderdale, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14710 | 21 CFR 820.150 | Lack of or inadequate procedures for storage. |
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3121 | 21 CFR 820.80(b) | Lack of or inadequate receiving acceptance procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3699 | 21 CFR 820.160(b) | Distribution records |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |