FDA Inspection
Aurident IncAurident Inc – FDA Inspection, Oct 15, 2026
Record Details
This FDA Inspection record concerns Aurident Inc, with an inspection on October 15, 2026, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Aurident Inc
- Inspection Date
- October 15, 2026
- Product Type
- Devices
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ID · 50dc2fba-1ae7-4957-9700-6aeac9810417
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1341670
- Project area
- Compliance: Devices
FDA Citations
3- ISO 13485:2016 Clause 7.3.10Design and development file does not include or reference required records
- ISO 13485:2016 Clause 7.1Supplier performance not monitored
- ISO 13485:2016 Clause 8.5.1QMS not reviewed by top management at documented planned intervals
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Other FDA inspections of Aurident Inc
3| Date | Classification | Office | Project area |
|---|---|---|---|
| September 27, 2018 | 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 1067019 - 2018-09-27
- FDA Inspection 816456 - 2013-01-29
- FDA Inspection 761092 - 2011-12-07
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