821205
Orion Vision Group — FEI 1000140384
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 8, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Marietta, GA (United States)
Citations
| ID | CFR | Description |
|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3426 | 21 CFR 820.50(a)(1) | Documented evaluation |
| 4059 | 21 CFR 820.22 | Quality Audits - defined intervals |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |
| 631 | 21 CFR 803.17(a)(1) | Lack of System for Event Evaluations |