Menicon Co., Ltd. Central Research Laboratory FDA Record

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

Menicon Co., Ltd. Central Research Laboratory has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Menicon Co., Ltd. Central Research Laboratory" is on file.

What these totals cover: FDA records filed under the name "Menicon Co., Ltd. Central Research Laboratory" and its spelling variant "Menicon Co., Ltd. Central Research Laboratory".

Latest inspection
Dec 10, 2015 · VAI

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
Inspections1Nov 14, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

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Recent FDA inspections

1 inspection on Dec 10, 2015.

DateSiteProductClassificationFEI
Dec 10, 2015Kasugai, JapanDevicesVoluntary Action Indicated (VAI)3003062331
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.

FDA-inspected facilities

1 inspected site, newest inspection first.

FacilityLocationInspectionsLatest
FEI 3003062331Kasugai, Japan1Dec 10, 2015

Menicon Co., Ltd. Central Research Laboratory and the FDA: common questions

Has Menicon Co., Ltd. Central Research Laboratory received an FDA warning letter?

No FDA warning letter addressed to the name "Menicon Co., Ltd. Central Research Laboratory" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.

Has Menicon Co., Ltd. Central Research Laboratory received an FDA Form 483?

FDA has not published a Form 483 for "Menicon Co., Ltd. Central Research Laboratory" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Menicon Co., Ltd. Central Research Laboratory?

The most recent FDA inspection on file ended Dec 10, 2015 at Kasugai, Japan and was classified VAI. FDA has 1 inspection of Menicon Co., Ltd. Central Research Laboratory on file.

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