FDA Inspection 680936 — Thermo Fisher Scientific (Asheville) LLC
The FDA completed an inspection of Thermo Fisher Scientific (Asheville) LLC on Sep 10, 2010 in Marietta, OH. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 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 |