1222868
AHA HYPERBARICS GMBH — FEI 3013938915
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 9, 2023
- Fiscal Year
- 2024
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Vienna (Austria)
Citations
| ID | CFR | Description |
|---|
| 2327 | 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures |
| 3101 | 21 CFR 820.30(g) | Design validation- Lack of or inadequate procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 632 | 21 CFR 803.17(a)(2) | Lack of System for Determining MDR Events |