1014538
Orion Vision Group — FEI 1000140384
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- March 29, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Marietta, GA (United States)
Citations
| ID | CFR | Description |
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 2328 | 21 CFR 820.22 | Quality audits - auditor independence |
| 3375 | 21 CFR 820.198(e) | Records of complaint investigation |
| 3669 | 21 CFR 820.20(c) | Management review - defined interval, sufficient frequency |
| 3696 | 21 CFR 820.100(b) | Documentation |