FDA Inspection
VivaQuant, Inc.VivaQuant, Inc. – FDA Inspection, Jun 29, 2026
Record Details
This FDA Inspection record concerns VivaQuant, Inc., with an inspection on June 29, 2026, issued by the Minneapolis District Office, covering medical devices & rad health.
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ID · fafcec0c-f096-4d8b-8d08-c71c51ca6ea3
Inspection Facts
- Inspection number
- 1318340
- FDA center
- Medical Devices & Rad Health
- Project area
- Project Evaluation: Devices
- Outcome
- Form 483 issued
FDA Citations
2- ISO 13485:2016 Clause 7.3.1Design and development procedures not documented
- ISO 13485:2016 Clause 8.5.2Corrective action records not maintained
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Other FDA inspections of VivaQuant, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 25, 2021 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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