FDA Inspection
Blueroot Health, Inc.Blueroot Health, Inc. – FDA Inspection, Aug 19, 2026
Record Details
This FDA Inspection record concerns Blueroot Health, Inc., with an inspection on August 19, 2026, issued by the Center for Devices and Radiological Health, covering medical devices & rad health.
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ID · dd508bac-4c9d-40ac-be63-5d9cea2d7f44
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1331668
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- ISO 13485:2016 Clause 8.2.2Complaint handling procedures lack required elements
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Blueroot Health, Inc.
8| Date | Classification | Office | Project area |
|---|---|---|---|
| April 20, 2026 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| September 22, 2021 | NAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
| June 30, 2017 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| December 9, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 25, 2014 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
Other documents for Blueroot Health, Inc.
- FDA Inspection 1313834 - 2026-04-20
- FDA Inspection 1153999 - 2021-09-22
- FDA Inspection 1019254 - 2017-06-30
- FDA Inspection 994804 - 2016-12-09
- FDA Inspection 886474 - 2014-06-25
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