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ORTHOPEDIATRICS CANADA ULC FDA Record

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

Latest inspection VAI · Mar 1, 2018
Last warning letter 2010

Inspections 3

2 OAI

Recalls 0 0 Class I

Warning letters 1 Latest Oct 26, 2010

510(k) clearances 0 None on file

ORTHOPEDIATRICS CANADA ULC has 0 FDA recalls, 3 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to ORTHOPEDIATRICS CANADA ULC, the most recent on Oct 26, 2010.

What these totals cover: FDA records filed under the name "ORTHOPEDIATRICS CANADA ULC".

Latest inspection: Mar 1, 2018 · VAI

Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	0	Nov 11, 2026 (checked Nov 15, 2026, unchanged)	File dated Nov 10, 2026	Current
510(k) clearances	0	Nov 15, 2026	File dated Nov 9, 2026	Current
Inspections	3	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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ORTHOPEDIATRICS CANADA ULC FDA Warning Letters

1 warning letter on Oct 26, 2010.

Issued	Subject	Issuing office	Close-out letter
Oct 26, 2010 · 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

3 inspections from Mar 31, 2010 to Mar 1, 2018.

Date	Site	Product	Classification	FEI
Mar 1, 2018	Laval, Canada	Devices	Voluntary Action Indicated (VAI)	3000327445
Jul 25, 2013	Laval, Canada	Devices	Official Action Indicated (OAI)	3000327445
Mar 31, 2010	Laval, Canada	Devices	Official Action Indicated (OAI)	3000327445

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 ORTHOPEDIATRICS CANADA ULC: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Oct 26, 2010.

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 3000327445	Laval, Canada	3	Mar 1, 2018

ORTHOPEDIATRICS CANADA ULC and the FDA: common questions

Has ORTHOPEDIATRICS CANADA ULC received an FDA warning letter?

Yes. FDA has issued 1 warning letter to ORTHOPEDIATRICS CANADA ULC. The most recent is dated Oct 26, 2010.

Has ORTHOPEDIATRICS CANADA ULC received an FDA Form 483?

FDA has not published a Form 483 for "ORTHOPEDIATRICS CANADA ULC" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect ORTHOPEDIATRICS CANADA ULC?

The most recent FDA inspection on file ended Mar 1, 2018 at Laval, Canada and was classified VAI. FDA has 3 inspections of ORTHOPEDIATRICS CANADA ULC on file, 2 of them classified OAI (official action indicated).

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