FDA Inspection 929266 — SOMNOmedics AG
The FDA completed an inspection of SOMNOmedics AG on May 7, 2015 in Randersacker. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 7, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Randersacker (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 3118 | 21 CFR 820.75(a) | Documentation |
| 3159 | 21 CFR 820.184 | DHR content |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |