International Laboratories (Canada) Ltd. FDA Record

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

  • Latest inspection OAI · Sep 27, 2013
  • Last warning letter 2012
Inspections 2 2 OAI
Recalls 0 0 Class I
Warning letters 1 Latest Oct 23, 2012
510(k) clearances 0 None on file

International Laboratories (Canada) Ltd. has 0 FDA recalls, 2 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to International Laboratories (Canada) Ltd., the most recent on Oct 23, 2012.

What these totals cover: FDA records filed under the name "International Laboratories (Canada) Ltd." and its spelling variant "International Laboratories (Canada)".

Latest inspection
Sep 27, 2013 · OAI

Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 11, 2026 (checked Nov 15, 2026, unchanged)File dated Nov 10, 2026Current
510(k) clearances0Nov 15, 2026File dated Nov 9, 2026Current
Inspections2Nov 15, 2026Newest record Nov 5, 2026Current
Compliance actions1Nov 2, 2026Newest record Oct 29, 2026Current

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International Laboratories (Canada) Ltd. FDA Warning Letters

1 warning letter on Oct 23, 2012.

IssuedSubjectIssuing officeClose-out letter
Oct 23, 2012 · 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 Feb 16, 2012 to Sep 27, 2013.

DateSiteProductClassificationFEI
Sep 27, 2013Calgary, CanadaDrugsOfficial Action Indicated (OAI)3005256547
Feb 16, 2012Calgary, CanadaDrugsOfficial Action Indicated (OAI)3005256547
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 International Laboratories (Canada) Ltd.: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Oct 23, 2012.

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.

FacilityLocationInspectionsLatest
FEI 3005256547Calgary, Canada2Sep 27, 2013

International Laboratories (Canada) Ltd. and the FDA: common questions

Has International Laboratories (Canada) Ltd. received an FDA warning letter?

Yes. FDA has issued 1 warning letter to International Laboratories (Canada) Ltd.. The most recent is dated Oct 23, 2012.

Has International Laboratories (Canada) Ltd. received an FDA Form 483?

FDA has not published a Form 483 for "International Laboratories (Canada) Ltd." in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect International Laboratories (Canada) Ltd.?

The most recent FDA inspection on file ended Sep 27, 2013 at Calgary, Canada and was classified OAI. FDA has 2 inspections of International Laboratories (Canada) Ltd. on file, 2 of them classified OAI (official action indicated).

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Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.