Mitsutoyo Co. Ltd., Hakodate Plant FDA Record

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

  • Latest inspection VAI · Jul 16, 2019
  • Last warning letter 2013
Inspections 3 0 OAI
Recalls 0 0 Class I
Warning letters 1 Latest Mar 4, 2013
510(k) clearances 0 None on file

Mitsutoyo Co. Ltd., Hakodate Plant has 0 FDA recalls, 3 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Mitsutoyo Co. Ltd., Hakodate Plant, the most recent on Mar 4, 2013.

What these totals cover: FDA records filed under the name "Mitsutoyo Co. Ltd., Hakodate Plant".

Latest inspection
Jul 16, 2019 · VAI

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
Inspections3Nov 15, 2026Newest record Nov 5, 2026Current
Compliance actions1Nov 2, 2026Newest record Oct 29, 2026Current

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Mitsutoyo Co. Ltd., Hakodate Plant FDA Warning Letters

1 warning letter on Mar 4, 2013.

IssuedSubjectIssuing officeClose-out letter
Mar 4, 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

3 inspections from Nov 16, 2012 to Jul 16, 2019.

DateSiteProductClassificationFEI
Jul 16, 2019Hokuto, JapanFood/CosmeticsVoluntary Action Indicated (VAI)3004336309
Jan 30, 2015Hokuto, JapanFood/CosmeticsVoluntary Action Indicated (VAI)3004336309
Nov 16, 2012Hokuto, JapanFood/CosmeticsNo Action Indicated (NAI)3004336309
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 Mitsutoyo Co. Ltd., Hakodate Plant: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Mar 4, 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.

FacilityLocationInspectionsLatest
FEI 3004336309Hokuto, Japan3Jul 16, 2019

Mitsutoyo Co. Ltd., Hakodate Plant and the FDA: common questions

Has Mitsutoyo Co. Ltd., Hakodate Plant received an FDA warning letter?

Yes. FDA has issued 1 warning letter to Mitsutoyo Co. Ltd., Hakodate Plant. The most recent is dated Mar 4, 2013.

Has Mitsutoyo Co. Ltd., Hakodate Plant received an FDA Form 483?

FDA has not published a Form 483 for "Mitsutoyo Co. Ltd., Hakodate Plant" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Mitsutoyo Co. Ltd., Hakodate Plant?

The most recent FDA inspection on file ended Jul 16, 2019 at Hokuto, Japan and was classified VAI. FDA has 3 inspections of Mitsutoyo Co. Ltd., Hakodate Plant on file.

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