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Mitsutoyo Co. Ltd., Hakodate Plant FDA Inspection Record

FEI 3004336309 · Inspections, Form 483s, warning letters and import refusals

Mitsutoyo Co. Ltd., Hakodate Plant is an FDA-inspected facility (FEI 3004336309) located in Hokuto, JP. RegDataLab tracks 3 FDA inspections and 1 compliance action at this facility.

What FDA found at this site

Latest inspection
Jul 16, 2019: Voluntary Action Indicated (VAI)
Inspections on record
3 (2 VAI, 1 NAI)
Last OAI inspection
None on record
Warning letters
1 listed by FDA for this FEI, latest Mar 4, 2013
Import refusals
2

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Newest first. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
Jul 16, 2019Voluntary Action Indicated (VAI)No citations listed
Jan 30, 2015Voluntary Action Indicated (VAI)Sanitation monitoring (21 CFR 123.11(b))
Monitoring - adequacy (21 CFR 123.6(c)(4))
HACCP plan implementation (21 CFR 123.6(b))
Critical control points (21 CFR 123.6(c)(2))
Nov 16, 2012No Action Indicated (NAI)Sanitation monitoring (21 CFR 123.11(b))
Monitoring - adequacy (21 CFR 123.6(c)(4))
Verification procedures - adequacy (21 CFR 123.6(c)(6))
Calibration - adequacy (21 CFR 123.8(a)(2)(ii))
and 2 more

FDA record score

2 of 100. A count of this site's adverse public FDA records, weighted by how recent each one is. A higher number means more, or more recent, records. Each record below adds the points shown.

Counted on Nov 15, 2026, method version 1. It counts records and does not judge the site: a low number does not establish that a site is safe, and sites that FDA inspects more often can collect more points. How this is counted.

3 records behind this number
RecordDatePoints x age weightAdds
Inspection classified VAIJul 16, 20196 x 0.251.5
Inspection classified VAIJan 30, 201510 years or older, so it adds no points0
Warning letter on FDA's dashboard, which does not show close-outsMar 4, 201310 years or older, so it adds no points0

When each source was last refreshed

FDA sources behind this page and when RegDataLab last refreshed each one
RecordsLast refreshedSource as ofStatus
InspectionsNov 15, 2026Newest record Nov 5, 2026Current
Inspection citationsNov 15, 2026Newest record Nov 5, 2026Current
Compliance actions (warning letters, injunctions and other action types)Nov 2, 2026Newest record Oct 29, 2026Current
Warning letter textNov 14, 2026Newest record Nov 10, 2026Current
Recalls (Enforcement Report)Nov 15, 2026Newest record Nov 11, 2026Current
Form 483s and inspection documentsNov 13, 2026Newest record Nov 12, 2026Current
Import refusalsNov 15, 2026Newest record Nov 5, 2026Current

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Facility details

Company
Mitsutoyo Co. Ltd., Hakodate Plant
Location
Hokuto (JP)
Source
inspections

Compliance actions

Import refusals

FDA data resources

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