FDA Inspection
Advanced Breath Diagnostics, LLC dba Cairn DiagnosticsAdvanced Breath Diagnostics, LLC dba Cairn Diagnostics – FDA Inspection, Sep 14, 2016
Record Details
This FDA Inspection record concerns Advanced Breath Diagnostics, LLC dba Cairn Diagnostics, with an inspection on September 14, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- September 14, 2016
- Product Type
- Devices
View Company Profile
ID · fa8ee797-ca89-4a5a-a1f6-a49517bce0e5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 985069
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
Other FDA inspections of Advanced Breath Diagnostics, LLC dba Cairn Diagnostics
4| Date | Classification | Office | Project area |
|---|---|---|---|
| May 18, 2023 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| January 22, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| November 20, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 19, 2012 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for Advanced Breath Diagnostics, LLC dba Cairn Diagnostics
- FDA Inspection 1206618 - 2023-05-18
- FDA Inspection 911095 - 2015-01-22
- FDA Inspection 856779 - 2013-11-20
- FDA Inspection 806708 - 2012-10-19
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