FDA Inspection
Hyperbaric Technologies Inc.Hyperbaric Technologies Inc. – FDA Inspection, May 12, 2009
Record Details
This FDA Inspection record concerns Hyperbaric Technologies Inc., with an inspection on May 12, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Hyperbaric Technologies Inc.
- Inspection Date
- May 12, 2009
- Product Type
- Devices
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ID · b551cba2-4118-4ece-bdb5-6702e67f52d3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 578886
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
4- 21 CFR 820.100(a)(2)Investigation
- 21 CFR 820.198(a)(3)Processing MDRs {see also 803, 804}
- 21 CFR 820.120Lack of or inadequate procedures for labeling
- 21 CFR 820.198(b)Review and evaluation for investigation
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Other FDA inspections of Hyperbaric Technologies Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| September 26, 2018 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| February 20, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 4, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Hyperbaric Technologies Inc.
- FDA Inspection 1066879 - 2018-09-26
- FDA Inspection 819582 - 2013-02-20
- FDA Inspection 709392 - 2011-02-04
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