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Yamaharu Co., Ltd. FDA Record

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

Yamaharu Co., Ltd. has 0 FDA recalls, 2 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Yamaharu Co., Ltd., the most recent on Sep 24, 2014.

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

Latest inspection: Nov 1, 2019 · VAI

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Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	0	Nov 8, 2026	File dated Nov 3, 2026	Current
510(k) clearances	0	Nov 8, 2026	File dated Nov 2, 2026	Current
Inspections	2	Nov 14, 2026	Newest record Nov 5, 2026	Current
Compliance actions	1	Nov 2, 2026	Newest record Oct 29, 2026	Current

Yamaharu Co., Ltd. FDA Warning Letters

1 warning letter on Sep 24, 2014.

Issued	Subject	Issuing office	Close-out letter
Sep 24, 2014

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

2 inspections from Apr 2, 2014 to Nov 1, 2019.

Date	Site	Product	Classification	FEI
Nov 1, 2019	Koto, Japan	Food/Cosmetics	Voluntary Action Indicated (VAI)	3004791456
Apr 2, 2014	Koto, Japan	Food/Cosmetics	Official Action Indicated (OAI)	3004791456

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 Yamaharu Co., Ltd.: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Sep 24, 2014.

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.

Facility	Location	Inspections	Latest
FEI 3004791456	Koto, Japan	2	Nov 1, 2019

Yamaharu Co., Ltd. and the FDA: common questions

Has Yamaharu Co., Ltd. received an FDA warning letter?

Yes. FDA has issued 1 warning letter to Yamaharu Co., Ltd.. The most recent is dated Sep 24, 2014.

Has Yamaharu Co., Ltd. received an FDA Form 483?

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

When did the FDA last inspect Yamaharu Co., Ltd.?

The most recent FDA inspection on file ended Nov 1, 2019 at Koto, Japan and was classified VAI. FDA has 2 inspections of Yamaharu Co., Ltd. on file, 1 of them classified OAI (official action indicated).

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