1151741
Compumedics USA, Inc — FEI 3002716534
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 16, 2021
- Fiscal Year
- 2021
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Charlotte, NC (United States)
Citations
| ID | CFR | Description |
|---|
| 2350 | 21 CFR 820.25(b) | Training - Lack of or inadequate procedures |
| 3170 | 21 CFR 820.198(b) | Review and evaluation for investigation |
| 3203 | 21 CFR 820.40(b) | Document change records, maintained. |
| 3323 | 21 CFR 820.170(b) | Installer records |
| 3409 | 21 CFR 820.200(d) | Service reports |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 3427 | 21 CFR 820.50(a)(2) | Supplier oversight |
| 3665 | 21 CFR 820.20(b)(3) | Management representative |
| 3668 | 21 CFR 820.20(c) | Management review dates |
| 3696 | 21 CFR 820.100(b) | Documentation |