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Prime Health Products FDA Record

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

Prime Health Products has 0 FDA recalls, 4 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Prime Health Products, the most recent on Jul 29, 2015.

What these totals cover: FDA records filed under the name "Prime Health Products".

Latest inspection: Feb 27, 2020 · NAI

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	4	Nov 14, 2026	Newest record Nov 5, 2026	Current
Compliance actions	1	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

Prime Health Products'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	0	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	1	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.

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Prime Health Products FDA Warning Letters

1 warning letter on Jul 29, 2015.

Issued	Subject	Issuing office	Close-out letter
Jul 29, 2015 · Record page

A warning letter is FDA's formal notice that a company has violated FDA requirements. Each date links to the letter on fda.gov where FDA has it online. Search the text of every letter with the FDA warning letter search.

Recent FDA inspections

4 inspections from Mar 22, 2013 to Feb 27, 2020.

Date	Site	Product	Classification	FEI
Feb 27, 2020	Etobicoke, Canada	Food/Cosmetics	No Action Indicated (NAI)	3004332606
Jun 21, 2018	Etobicoke, Canada	Food/Cosmetics	Voluntary Action Indicated (VAI)	3004332606
Sep 10, 2014	Etobicoke, Canada	Food/Cosmetics	Official Action Indicated (OAI)	3004332606
Mar 22, 2013	Etobicoke, Canada	Food/Cosmetics	Voluntary Action Indicated (VAI)	3004332606

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.

Compliance Actions

FDA's compliance actions data lists 1 compliance action under Prime Health Products: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Jul 29, 2015.

The warning letters in this data are listed above, together with the letters FDA posts online; a letter found in both is shown once. Other actions are not listed on this page. Search them with the FDA warning letter search or browse all compliance actions.

FDA-inspected facilities

1 inspected site, newest inspection first.

Facility	Location	Inspections	Latest
FEI 3004332606	Etobicoke, Canada	4	Feb 27, 2020

Prime Health Products and the FDA: common questions

Has Prime Health Products received an FDA warning letter?

Yes. FDA has issued 1 warning letter to Prime Health Products. The most recent is dated Jul 29, 2015.

Has Prime Health Products received an FDA Form 483?

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

When did the FDA last inspect Prime Health Products?

The most recent FDA inspection on file ended Feb 27, 2020 at Etobicoke, Canada and was classified NAI. FDA has 4 inspections of Prime Health Products on file, 1 of them classified OAI (official action indicated).

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