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Aztex Enterprises Ltd. FDA Record

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

Aztex Enterprises Ltd. has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Aztex Enterprises Ltd., the most recent on Oct 23, 2017.

What these totals cover: FDA records filed under the name "Aztex Enterprises Ltd." and its spelling variant "Aztex Enterprises".

Latest inspection: Jun 13, 2017 · OAI

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

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Aztex Enterprises Ltd. FDA Warning Letters

1 warning letter on Oct 23, 2017.

Issued	Subject	Issuing office	Close-out letter
Oct 23, 2017 · 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

1 inspection on Jun 13, 2017.

Date	Site	Product	Classification	FEI
Jun 13, 2017	Burlington, Canada	Drugs	Official Action Indicated (OAI)	3003516782

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 Aztex Enterprises Ltd.: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Oct 23, 2017.

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 3003516782	Burlington, Canada	1	Jun 13, 2017

Aztex Enterprises Ltd. and the FDA: common questions

Has Aztex Enterprises Ltd. received an FDA warning letter?

Yes. FDA has issued 1 warning letter to Aztex Enterprises Ltd.. The most recent is dated Oct 23, 2017.

Has Aztex Enterprises Ltd. received an FDA Form 483?

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

When did the FDA last inspect Aztex Enterprises Ltd.?

The most recent FDA inspection on file ended Jun 13, 2017 at Burlington, Canada and was classified OAI. FDA has 1 inspection of Aztex Enterprises Ltd. on file, 1 of them classified OAI (official action indicated).

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