FDA Inspection
Aurident IncAurident Inc – FDA Inspection, Sep 27, 2018
Record Details
This FDA Inspection record concerns Aurident Inc, with an inspection on September 27, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · ef8aaa1e-94be-4115-b2a7-e15b627b3e50
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1067019
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.184Lack of or inadequate DHR procedures
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Other FDA inspections of Aurident Inc
3| Date | Classification | Office | Project area |
|---|---|---|---|
| October 15, 2026 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 29, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 7, 2011 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Aurident Inc
- FDA Inspection 1341670 - 2026-10-15
- FDA Inspection 816456 - 2013-01-29
- FDA Inspection 761092 - 2011-12-07
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