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Coastal Contacts Inc. FDA Record

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

Latest inspection VAI · Apr 9, 2015
Last warning letter 2013

Inspections 2

1 OAI

Recalls 0 0 Class I

Warning letters 1 Latest Dec 11, 2013

510(k) clearances 0 None on file

Coastal Contacts Inc. has 0 FDA recalls, 2 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Coastal Contacts Inc., the most recent on Dec 11, 2013.

What these totals cover: FDA records filed under the name "Coastal Contacts Inc." and its spelling variant "Coastal Contacts".

Latest inspection: Apr 9, 2015 · 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	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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Coastal Contacts Inc. FDA Warning Letters

1 warning letter on Dec 11, 2013.

Issued	Subject	Issuing office	Close-out letter
Dec 11, 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 Jul 31, 2013 to Apr 9, 2015.

Date	Site	Product	Classification	FEI
Apr 9, 2015	Vancouver, Canada	Devices	Voluntary Action Indicated (VAI)	3006066935
Jul 31, 2013	Vancouver, Canada	Devices	Official Action Indicated (OAI)	3006066935

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

Most recent: Warning Letter, Dec 11, 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 3006066935	Vancouver, Canada	2	Apr 9, 2015

Coastal Contacts Inc. and the FDA: common questions

Has Coastal Contacts Inc. received an FDA warning letter?

Yes. FDA has issued 1 warning letter to Coastal Contacts Inc.. The most recent is dated Dec 11, 2013.

Has Coastal Contacts Inc. received an FDA Form 483?

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

When did the FDA last inspect Coastal Contacts Inc.?

The most recent FDA inspection on file ended Apr 9, 2015 at Vancouver, Canada and was classified VAI. FDA has 2 inspections of Coastal Contacts Inc. on file, 1 of them classified OAI (official action indicated).

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