Esdei Hachikan Co.,Ltd. FDA Record

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

  • Latest inspection NAI · Jul 19, 2019
  • No warning letters matched by name
Inspections 2 0 OAI
Recalls 0 0 Class I
Warning letters 0 None on file
510(k) clearances 0 None on file

Esdei Hachikan Co.,Ltd. has 0 FDA recalls, 2 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Esdei Hachikan Co.,Ltd." is on file.

What these totals cover: FDA records filed under the name "Esdei Hachikan Co.,Ltd." and its spelling variant "Esdei Hachikan Co".

Latest inspection
Jul 19, 2019 · NAI

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
Inspections2Nov 15, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

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Recent FDA inspections

2 inspections from Feb 6, 2015 to Jul 19, 2019.

DateSiteProductClassificationFEI
Jul 19, 2019Hachinohe, JapanFood/CosmeticsNo Action Indicated (NAI)3009963620
Feb 6, 2015Hachinohe, JapanFood/CosmeticsVoluntary Action Indicated (VAI)3009963620
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 3009963620Hachinohe, Japan2Jul 19, 2019

Esdei Hachikan Co.,Ltd. and the FDA: common questions

Has Esdei Hachikan Co.,Ltd. received an FDA warning letter?

No FDA warning letter addressed to the name "Esdei Hachikan Co.,Ltd." 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 Esdei Hachikan Co.,Ltd. received an FDA Form 483?

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

When did the FDA last inspect Esdei Hachikan Co.,Ltd.?

The most recent FDA inspection on file ended Jul 19, 2019 at Hachinohe, Japan and was classified NAI. FDA has 2 inspections of Esdei Hachikan Co.,Ltd. on file.

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