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Immunotec Research Incorporated FDA Record

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

Immunotec Research Incorporated has 0 FDA recalls, 2 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Immunotec Research Incorporated" is on file.

What these totals cover: FDA records filed under the name "Immunotec Research Incorporated".

Latest inspection: Mar 26, 2025 · VAI

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	2	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

Immunotec Research Incorporated'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	1	0	0	0	0
2023	0	0	0	0	0
2022	0	0	0	0	0
2021	0	0	0	0	0
2020	0	0	0	0	0
2019	0	0	0	0	0
2018	0	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.

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Recent FDA inspections

2 inspections from Aug 21, 2024 to Mar 26, 2025.

Date	Site	Product	Classification	FEI
Mar 26, 2025	The Woodlands, TX	Food/Cosmetics	Voluntary Action Indicated (VAI)	3015601250
Aug 21, 2024	The Woodlands, TX	Food/Cosmetics	Voluntary Action Indicated (VAI)	3015601250

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 3015601250	The Woodlands, TX	2	Mar 26, 2025

Immunotec Research Incorporated and the FDA: common questions

Has Immunotec Research Incorporated received an FDA warning letter?

No FDA warning letter addressed to the name "Immunotec Research Incorporated" 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 Immunotec Research Incorporated received an FDA Form 483?

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

When did the FDA last inspect Immunotec Research Incorporated?

The most recent FDA inspection on file ended Mar 26, 2025 at The Woodlands, TX and was classified VAI. FDA has 2 inspections of Immunotec Research Incorporated on file.

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