680936
Thermo Fisher Scientific (Asheville) LLC — FEI 1523845
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 10, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Marietta, OH (United States)
Citations
| ID | CFR | Description |
|---|
| 1689 | 21 CFR 110.80 | Reasonable precautions |
| 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 |
| 3661 | 21 CFR 110.37(e)(5) | Signs |