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Eyegaze Inc. FDA Record

Warning letters, Form 483s, inspections, recalls and 510(k) clearances

Eyegaze Inc. has 0 FDA recalls, 5 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Eyegaze Inc." is on file.

What these totals cover: FDA records filed under the name "Eyegaze Inc." and its spelling variant "Eyegaze".

Latest inspection: May 2, 2025 · NAI

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Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	0	Nov 8, 2026	File dated Nov 3, 2026	Current
510(k) clearances	0	Nov 8, 2026	File dated Nov 2, 2026	Current
Inspections	5	Nov 14, 2026	Newest record Nov 5, 2026	Current
Compliance actions	0	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

Eyegaze Inc.'s FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Year	Inspections	OAI	Warning letters	Recall records	Class I
2026	0	0	0	0	0
2025	1	0	0	0	0
2024	0	0	0	0	0
2023	0	0	0	0	0
2022	0	0	0	0	0
2021	1	0	0	0	0
2020	0	0	0	0	0
2019	0	0	0	0	0
2018	1	0	0	0	0
2017	0	0	0	0	0

Inspections are counted by the date they ended, warning letters by the date FDA issued them and recall records by the recall start date. FDA lists one recall record per recalled product, so one recall event can add several.

Recent FDA inspections

5 inspections from Apr 23, 2015 to May 2, 2025.

Date	Site	Product	Classification	FEI
May 2, 2025	Fairfax, VA	Devices	No Action Indicated (NAI)	1000123308
Oct 8, 2021	Fairfax, VA	Devices	Voluntary Action Indicated (VAI)	1000123308
Oct 5, 2018	Fairfax, VA	Devices	Voluntary Action Indicated (VAI)	1000123308
Sep 15, 2016	Fairfax, VA	Devices	No Action Indicated (NAI)	1000123308
Apr 23, 2015	Fairfax, VA	Devices	Voluntary Action Indicated (VAI)	1000123308

NAI: No objectionable conditions or practices were found during the inspection.
VAI: Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
OAI: Regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

FDA-inspected facilities

1 inspected site, newest inspection first.

Facility	Location	Inspections	Latest
FEI 1000123308	Fairfax, VA	5	May 2, 2025

Eyegaze Inc. and the FDA: common questions

Has Eyegaze Inc. received an FDA warning letter?

No FDA warning letter addressed to the name "Eyegaze Inc." is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.

Has Eyegaze Inc. received an FDA Form 483?

FDA has not published a Form 483 for "Eyegaze Inc." in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Eyegaze Inc.?

The most recent FDA inspection on file ended May 2, 2025 at Fairfax, VA and was classified NAI. FDA has 5 inspections of Eyegaze Inc. on file.

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