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Batrik Medical Mfg., Inc. FDA Record

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

Latest inspection VAI · Jul 16, 2015
Last warning letter 2013

Inspections 2

1 OAI

Recalls 0 0 Class I

Warning letters 1 Latest Sep 23, 2013

510(k) clearances 0 None on file

Batrik Medical Mfg., Inc. has 0 FDA recalls, 2 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Batrik Medical Mfg., Inc., the most recent on Sep 23, 2013.

What these totals cover: FDA records filed under the name "Batrik Medical Mfg., Inc." and its spelling variant "Batrik Medical Mfg".

Latest inspection: Jul 16, 2015 · 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 15, 2026	Newest record Nov 5, 2026	Current
Compliance actions	1	Nov 2, 2026	Newest record Oct 29, 2026	Current

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Batrik Medical Mfg., Inc. FDA Warning Letters

1 warning letter on Sep 23, 2013.

Issued	Subject	Issuing office	Close-out letter
Sep 23, 2013 · 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

2 inspections from Jun 27, 2013 to Jul 16, 2015.

Date	Site	Product	Classification	FEI
Jul 16, 2015	Lachine, Canada	Devices	Voluntary Action Indicated (VAI)	3003749234
Jun 27, 2013	Lachine, Canada	Devices	Official Action Indicated (OAI)	3003749234

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 Batrik Medical Mfg., Inc.: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Sep 23, 2013.

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 3003749234	Lachine, Canada	2	Jul 16, 2015

Batrik Medical Mfg., Inc. and the FDA: common questions

Has Batrik Medical Mfg., Inc. received an FDA warning letter?

Yes. FDA has issued 1 warning letter to Batrik Medical Mfg., Inc.. The most recent is dated Sep 23, 2013.

Has Batrik Medical Mfg., Inc. received an FDA Form 483?

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

When did the FDA last inspect Batrik Medical Mfg., Inc.?

The most recent FDA inspection on file ended Jul 16, 2015 at Lachine, Canada and was classified VAI. FDA has 2 inspections of Batrik Medical Mfg., Inc. on file, 1 of them classified OAI (official action indicated).

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