Company
AustriaAHA Hyperbarics GmbH, Vienna, Austria – FDA Inspections
Inspection records and compliance data for AHA Hyperbarics GmbH in Vienna. 2 FDA inspections on record, 2 Form 483s, last inspected November 09, 2023.
Company Profile
This profile covers AHA Hyperbarics GmbH based in Vienna, Austria.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 2
- NAI
- 0
- Form 483s
- 2
- Warning letters
- 0
First inspected November 29, 2018. Last inspected November 9, 2023.
Most cited issue areas
- Design validation- Lack of or inadequate procedures1 inspection
- Documentation1 inspection
- Documented evaluation1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 9, 2023 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1222868 |
| November 29, 2018 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1073289 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
AHA Hyperbarics GmbH
FEI Number
3013938915
Address
Mellergasse 4, Vienna, Austria
Country
Austria
ID: 3b0d6fcf-9046-463f-9d15-a53dc311fb4b