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Kenvue Canada Inc. FDA Record

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

Kenvue Canada Inc. has 0 FDA recalls, 3 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Kenvue Canada Inc." is on file.

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

Latest inspection: Apr 15, 2025 · VAI

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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	3	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

Kenvue Canada 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	0	0	0	0	0
2020	0	0	0	0	0
2019	0	0	0	0	0
2018	0	0	0	0	0
2017	1	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

3 inspections from Jul 23, 2010 to Apr 15, 2025.

Date	Site	Product	Classification	FEI
Apr 15, 2025	Guelph, Canada	Drugs	Voluntary Action Indicated (VAI)	1000328785
Dec 1, 2017	Guelph, Canada	Drugs	No Action Indicated (NAI)	1000328785
Jul 23, 2010	Guelph, Canada	Drugs	Voluntary Action Indicated (VAI)	1000328785

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 1000328785	Guelph, Canada	3	Apr 15, 2025

Kenvue Canada Inc. and the FDA: common questions

Has Kenvue Canada Inc. received an FDA warning letter?

No FDA warning letter addressed to the name "Kenvue Canada 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 Kenvue Canada Inc. received an FDA Form 483?

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

When did the FDA last inspect Kenvue Canada Inc.?

The most recent FDA inspection on file ended Apr 15, 2025 at Guelph, Canada and was classified VAI. FDA has 3 inspections of Kenvue Canada Inc. on file.

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