FDA Inspection
Air Techniques IncAir Techniques Inc – FDA Inspection, Apr 29, 2016
Record Details
This FDA Inspection record concerns Air Techniques Inc, with an inspection on April 29, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Air Techniques Inc
- Inspection Date
- April 29, 2016
- Product Type
- Devices
View Company Profile
ID · 21a2b264-93ae-4953-8eb7-e9644c7022fa
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 969945
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.120(d)Records, DHR {see also 820.184(e)}
- 21 CFR 820.75(a)Documentation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Air Techniques Inc
5| Date | Classification | Office | Project area |
|---|---|---|---|
| June 6, 2019 | NAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
| October 19, 2016 | NAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
| September 12, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 20, 2012 | VAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
| February 5, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Air Techniques Inc
- FDA Inspection 1115251 - 2019-06-06
- FDA Inspection 989060 - 2016-10-19
- FDA Inspection 896921 - 2014-09-12
- FDA Inspection 795593 - 2012-08-20
- FDA Inspection 651132 - 2010-02-05
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