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Ito En (Hawaii) LLC

FDA Regulatory Profile

Ito En (Hawaii) LLC has 0 FDA recalls, 6 inspections, 0 510(k) clearances and 1 compliance action on record.

Latest inspection
May 13, 2025 · NAI

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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
Inspections6Nov 11, 2026Newest record Nov 5, 2026Current
Compliance actions1Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
May 13, 2025Honolulu, HIFood/CosmeticsNo Action Indicated (NAI)2915475
Oct 6, 2017Honolulu, HIFood/CosmeticsNo Action Indicated (NAI)2915475
Apr 28, 2015Honolulu, HIFood/CosmeticsNo Action Indicated (NAI)2915475
Aug 23, 2013Honolulu, HIFood/CosmeticsVoluntary Action Indicated (VAI)2915475
Jul 2, 2012Honolulu, HIFood/CosmeticsOfficial Action Indicated (OAI)2915475
Mar 16, 2009Honolulu, HIFood/CosmeticsVoluntary Action Indicated (VAI)2915475

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means 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

FacilityLocationInspectionsLatest
FEI 2915475Honolulu, HI6May 13, 2025

FDA data resources

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