871900
3M Unitek Corporation — FEI 2020467
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 27, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Monrovia, CA (United States)
Citations
| ID | CFR | Description |
|---|
| 2350 | 21 CFR 820.25(b) | Training - Lack of or inadequate procedures |
| 2557 | 21 CFR 820.30(c) | Design input - documentation |
| 2630 | 21 CFR 820.30(e) | Design review - documentation |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3204 | 21 CFR 820.40(b) | Change records, content |
| 3237 | 21 CFR 820.72(b) | Remedial action |
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |