FDA Inspection 1331668 — Blueroot Health, Inc.
The FDA completed an inspection of Blueroot Health, Inc. on Aug 19, 2026 in Middletown, CT. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 1 citation was issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Aug 19, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Middletown, CT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23215 | ISO 13485:2016 Clause 8.2.2 | Complaint handling procedures lack required elements |