1013301
Columbia Scientific Development LLC — FEI 3012321270
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 7, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Portland, OR (United States)
Citations
| ID | CFR | Description |
|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 14722 | 21 CFR 820.40 | Procedures not adequately established or maintained |
| 2604 | 21 CFR 820.30(e) | Design review - Lack of or inadequate procedures |
| 3104 | 21 CFR 820.30(j) | Design history file |
| 3160 | 21 CFR 820.184 | Lack of or inadequate DHR procedures |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 3666 | 21 CFR 820.20(c) | Management review - Lack of or inadequate procedures |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |