710770
Orion Vision Group — FEI 1000140384
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- February 9, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Marietta, GA (United States)
Citations
| ID | CFR | Description |
|---|
| 3170 | 21 CFR 820.198(b) | Review and evaluation for investigation |
| 3173 | 21 CFR 820.198(d) | Evaluation, timeliness, identification |
| 3207 | 21 CFR 820.50(b) | Supplier notification of changes |
| 3269 | 21 CFR 820.80(b) | Incoming acceptance records, documentation |
| 3313 | 21 CFR 820.120(d) | Records, DHR {see also 820.184(e)} |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 454 | 21 CFR 820.40(a) | Document review, approval by designated individual |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |