FDA Inspection 1073289 — AHA HYPERBARICS GMBH
The FDA completed an inspection of AHA HYPERBARICS GMBH on Nov 29, 2018 in Vienna. 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). 4 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 29, 2018
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Vienna (Austria)
Citations
| ID | CFR | Description |
|---|---|---|
| 3118 | 21 CFR 820.75(a) | Documentation |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 3426 | 21 CFR 820.50(a)(1) | Documented evaluation |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |