1066293
VicTorch Meditek, Inc — FEI 3003323921
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 17, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- San Diego, CA (United States)
Citations
| ID | CFR | Description |
|---|
| 2327 | 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures |
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 3233 | 21 CFR 820.72(a) | Calibration, Inspection, etc. Procedures Lack of or Inadequ |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |