FDA Inspection
Hyperbaric Technologies Inc.Hyperbaric Technologies Inc. – FDA Inspection, Sep 26, 2018
Record Details
This FDA Inspection record concerns Hyperbaric Technologies Inc., with an inspection on September 26, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · e1ab615f-9f96-4eff-a7ae-eec03f5d3844
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1066879
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.40(b)Document change records, maintained.
- 21 CFR 820.184DHR content
- 21 CFR 820.75(a)Documentation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Hyperbaric Technologies Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| February 20, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 4, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 12, 2009 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Hyperbaric Technologies Inc.
- FDA Inspection 819582 - 2013-02-20
- FDA Inspection 709392 - 2011-02-04
- FDA Inspection 578886 - 2009-05-12
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