FDA Inspection 680936 — Thermo Fisher Scientific (Asheville) LLC
The FDA completed an inspection of Thermo Fisher Scientific (Asheville) LLC on September 10, 2010 in Marietta, OH. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Devices.
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 |