FDA Inspection
Hyperbaric For Life Llc.comHyperbaric For Life Llc.com – FDA Inspection, Apr 17, 2024
Record Details
This FDA Inspection record concerns Hyperbaric For Life Llc.com, with an inspection on April 17, 2024, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 76fa4200-0b35-4429-87ae-142c252cc8d0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1231705
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
13- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.20(d)Quality plan
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.20(e)Quality System Procedures
Showing 10 of 13 citations.
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Other FDA inspections of Hyperbaric For Life Llc.com
3| Date | Classification | Office | Project area |
|---|---|---|---|
| December 6, 2017 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| March 8, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 18, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Hyperbaric For Life Llc.com
- FDA Inspection 1035857 - 2017-12-06
- FDA Inspection 714314 - 2011-03-08
- FDA Inspection 645207 - 2010-02-18
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