973833
Columbia Scientific Development LLC — FEI 3012321270
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- May 18, 2016
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Portland, OR (United States)
Citations
| ID | CFR | Description |
|---|
| 14714 | 21 CFR 820.30(c) | Design input - Lack of or inadequate procedures |
| 14715 | 21 CFR 820.30(d) | Design output - Lack of or inadequate procedures |
| 2327 | 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures |
| 2604 | 21 CFR 820.30(e) | Design review - Lack of or inadequate procedures |
| 2650 | 21 CFR 820.30(f) | Design verification - Lack of or inadequate procedures |
| 3101 | 21 CFR 820.30(g) | Design validation- Lack of or inadequate procedures |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3120 | 21 CFR 820.80(a) | Lack of or inadequate procedures - Acceptance activities |
| 3160 | 21 CFR 820.184 | Lack of or inadequate DHR procedures |
| 3263 | 21 CFR 820.250(b) | Sampling plans |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 3666 | 21 CFR 820.20(c) | Management review - Lack of or inadequate procedures |
| 447 | 21 CFR 820.40 | Lack of procedures, or not maintained |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |