FDA Inspection
AHA Hyperbarics GmbHAHA Hyperbarics GmbH – FDA Inspection, Nov 9, 2023
Record Details
This FDA Inspection record concerns AHA Hyperbarics GmbH, with an inspection on November 9, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · eada2173-1c57-4f20-9481-9b4a29c1ee5b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1222868
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 803.17(a)(2)Lack of System for Determining MDR Events
- 21 CFR 803.17(a)(2)Lack of System for Determining MDR Events
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
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Other FDA inspections of AHA Hyperbarics GmbH
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 29, 2018 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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