EYEGAZE INC. FDA Inspection Record
EYEGAZE INC. is an FDA-registered facility (FEI 1000123308) located in FAIRFAX, VA, US. RegDataLab tracks 5 FDA inspections at this facility.
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What FDA found at this site
- Latest inspection
- May 2, 2025: No Action Indicated (NAI)
- Inspections on record
- 5 (3 VAI, 2 NAI)
- Last OAI inspection
- None on record
- Warning letters
- None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| May 2, 2025 | No Action Indicated (NAI) | Label to bear a unique device identifier (21 CFR 801.20(a)) Lack of or inadequate procedures for labeling (21 CFR 820.120) Nonconforming product, Lack of or inadequate procedures (21 CFR 820.90(a)) |
| Oct 8, 2021 | Voluntary Action Indicated (VAI) | Lack of or inadequate complaint procedures (21 CFR 820.198(a)) Procedures not adequately established or maintained (21 CFR 820.40) Training - Lack of or inadequate procedures (21 CFR 820.25(b)) Quality Audit/Reaudit - conducted (21 CFR 820.22) and 1 more |
| Oct 5, 2018 | Voluntary Action Indicated (VAI) | Lack of or inadequate final acceptance procedures (21 CFR 820.80(d)) Lack of or inadequate procedures (21 CFR 820.100(a)) Complaints (21 CFR 820.198(a)) Nonconforming product, Lack of or inadequate procedures (21 CFR 820.90(a)) |
| Sep 15, 2016 | No Action Indicated (NAI) | No citations listed |
| Apr 23, 2015 | Voluntary Action Indicated (VAI) | No citations listed |
Facility details
- Company
- Eyegaze Inc.
- Location
- FAIRFAX, VA (US)
- Source
- device