BLANCHARD VISION CORP. FDA Record

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

BLANCHARD VISION CORP. has 0 FDA recalls, 2 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to BLANCHARD VISION CORP., the most recent on Dec 23, 2011.

What these totals cover: FDA records filed under the name "BLANCHARD VISION CORP." and its spelling variant "Blanchard Vision".

Latest inspection
Feb 19, 2014 · NAI

Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections2Nov 14, 2026Newest record Nov 5, 2026Current
Compliance actions1Nov 2, 2026Newest record Oct 29, 2026Current

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BLANCHARD VISION CORP. FDA Warning Letters

1 warning letter on Dec 23, 2011.

IssuedSubjectIssuing officeClose-out letter
Dec 23, 2011

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 Sep 1, 2011 to Feb 19, 2014.

DateSiteProductClassificationFEI
Feb 19, 2014Sherbrooke, CanadaDevicesNo Action Indicated (NAI)3002807465
Sep 1, 2011Sherbrooke, CanadaDevicesOfficial Action Indicated (OAI)3002807465
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 BLANCHARD VISION CORP.: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Dec 23, 2011.

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 3002807465Sherbrooke, Canada2Feb 19, 2014

BLANCHARD VISION CORP. and the FDA: common questions

Has BLANCHARD VISION CORP. received an FDA warning letter?

Yes. FDA has issued 1 warning letter to BLANCHARD VISION CORP.. The most recent is dated Dec 23, 2011.

Has BLANCHARD VISION CORP. received an FDA Form 483?

FDA has not published a Form 483 for "BLANCHARD VISION CORP." in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect BLANCHARD VISION CORP.?

The most recent FDA inspection on file ended Feb 19, 2014 at Sherbrooke, Canada and was classified NAI. FDA has 2 inspections of BLANCHARD VISION CORP. on file, 1 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.