FDA Inspection
Hyperox IncHyperox Inc – FDA Inspection, Jan 28, 2009
Record Details
This FDA Inspection record concerns Hyperox Inc, with an inspection on January 28, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Hyperox Inc
- Inspection Date
- January 28, 2009
- Product Type
- Devices
View Company Profile
ID · 79bb9a77-6b8a-4c95-84a6-18f5e5bc1862
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 643381
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.20(e)Quality System Procedures
- 21 CFR 820.30(j)Design history file
- 21 CFR 820.20(b)Lack of or inadequate organizational structure
- 21 CFR 820.170(b)Installer"s documentation of results
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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