FDA Inspection 1268684 — Eyegaze Inc.
The FDA completed an inspection of Eyegaze Inc. on May 2, 2025 in Fairfax, VA. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 3 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- No Action Indicated (NAI)
- End Date
- May 2, 2025
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Fairfax, VA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 22795 | 21 CFR 801.20(a) | Label to bear a unique device identifier |
| 3132 | 21 CFR 820.120 | Lack of or inadequate procedures for labeling |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |