FDA Inspection 924750 — Thermo Electron LED GmbH
The FDA completed an inspection of Thermo Electron LED GmbH on January 22, 2015 in Langenselbold. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 22, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Langenselbold (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 3120 | 21 CFR 820.80(a) | Lack of or inadequate procedures - Acceptance activities |
| 3170 | 21 CFR 820.198(b) | Review and evaluation for investigation |