FDA Inspection
Air Innovations, Inc.Air Innovations, Inc. – FDA Inspection, Jan 23, 2014
Record Details
This FDA Inspection record concerns Air Innovations, Inc., with an inspection on January 23, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Air Innovations, Inc.
- Inspection Date
- January 23, 2014
- Product Type
- Devices
View Company Profile
ID · 4528ed2d-2f2a-4e11-a7de-f0d6dea72f33
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 865431
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
8- 21 CFR 820.80(e)Documentation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.200(a)Servicing - Lack of or inadequate procedures
- 21 CFR 820.200(d)Service reports
- 21 CFR 820.30(j)Design history file
- 21 CFR 820.184DHR content
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Air Innovations, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| December 8, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Air Innovations, Inc.
- FDA Inspection 995732 - 2016-12-08
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