820021
Vela Operations USA, Inc. — FEI 3009071564
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 27, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Salt Lake City, UT (United States)
Citations
| ID | CFR | Description |
|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 14720 | 21 CFR 820.50(a)(3) | Acceptable supplier records, inadequate records |
| 2350 | 21 CFR 820.25(b) | Training - Lack of or inadequate procedures |
| 3108 | 21 CFR 820.70(e) | Contamination control, Lack of or inadequate procedures |
| 3118 | 21 CFR 820.75(a) | Documentation |
| 3128 | 21 CFR 820.90(a) | Nonconforming product control |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3199 | 21 CFR 820.40(a) | Document review, approval documentation |
| 3226 | 21 CFR 820.70(g)(1) | Maintenance schedule, Lack of or inadequate schedule |
| 3264 | 21 CFR 820.250(b) | Sampling methods - Lack of or inadequate procedures |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 3345 | 21 CFR 820.200(a) | Servicing - Lack of or inadequate procedures |
| 3672 | 21 CFR 820.30(c) | Design input - review and approval |
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 3837 | 21 CFR 820.25(b) | Training records |
| 419 | 21 CFR 820.20(b) | Lack of or inadequate organizational structure |
| 502 | 21 CFR 820.60 | Identification procedures, Lack of or inadequate procedures |