FDA Inspection 1266030 — Cognivue Inc.
The FDA completed an inspection of Cognivue Inc. on June 13, 2025 in Victor, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 13, 2025
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Victor, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 22802 | 21 CFR 830.320(a) | GUDID Designation of contact for device identification. |
| 3375 | 21 CFR 820.198(e) | Records of complaint investigation |