AHA HYPERBARICS GMBH — FDA Facility Profile
AHA HYPERBARICS GMBH is an FDA-registered facility (FEI 3013938915) located in Vienna Wien, AT. RegDataLab tracks 2 FDA inspections at this facility.
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What FDA found at this site
- Latest inspection
- Nov 9, 2023: Voluntary Action Indicated (VAI)
- Inspections on record
- 2 (2 VAI)
- Last OAI inspection
- None on record
- Warning letters
- None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Nov 9, 2023 | Voluntary Action Indicated (VAI) | Quality audits - Lack of or inadequate procedures (21 CFR 820.22) Design validation- Lack of or inadequate procedures (21 CFR 820.30(g)) Lack of or inadequate procedures (21 CFR 820.100(a)) Lack of System for Determining MDR Events (21 CFR 803.17(a)(2)) |
| Nov 29, 2018 | Voluntary Action Indicated (VAI) | Documentation (21 CFR 820.75(a)) Quality Audit/Reaudit - conducted (21 CFR 820.22) Documented evaluation (21 CFR 820.50(a)(1)) Lack of Written MDR Procedures (21 CFR 803.17) |
Facility details
- Company
- AHA HYPERBARICS GMBH
- Location
- Vienna Wien (AT)
- Source
- device