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Dectro International, Inc. FDA Record

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

Latest inspection NAI · Dec 13, 2017
Last warning letter 2014

Inspections 1

0 OAI

Recalls 0 0 Class I

Warning letters 1 Latest May 22, 2014

510(k) clearances 0 None on file

Dectro International, Inc. has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Dectro International, Inc., the most recent on May 22, 2014.

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

Latest inspection: Dec 13, 2017 · 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	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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Dectro International, Inc. FDA Warning Letters

1 warning letter on May 22, 2014.

Issued	Subject	Issuing office	Close-out letter
May 22, 2014 · 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 Dec 13, 2017.

Date	Site	Product	Classification	FEI
Dec 13, 2017	Quebec, Canada	Devices	No Action Indicated (NAI)	3001446810

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 Dectro International, Inc.: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, May 22, 2014.

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 3001446810	Quebec, Canada	1	Dec 13, 2017

Dectro International, Inc. and the FDA: common questions

Has Dectro International, Inc. received an FDA warning letter?

Yes. FDA has issued 1 warning letter to Dectro International, Inc.. The most recent is dated May 22, 2014.

Has Dectro International, Inc. received an FDA Form 483?

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

When did the FDA last inspect Dectro International, Inc.?

The most recent FDA inspection on file ended Dec 13, 2017 at Quebec, Canada and was classified NAI. FDA has 1 inspection of Dectro International, Inc. on file.

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