FDA Inspection 794229 — SOMNOmedics AG
The FDA completed an inspection of SOMNOmedics AG on Jul 12, 2012 in Randersacker. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 12, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Randersacker (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 3237 | 21 CFR 820.72(b) | Remedial action |