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Marukai Foods Co., Inc. (Takasu Factory) FDA Record

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

Latest inspection OAI · Feb 20, 2014
Last warning letter 2014

Inspections 1

1 OAI

Recalls 0 0 Class I

Warning letters 1 Latest Jul 14, 2014

510(k) clearances 0 None on file

Marukai Foods Co., Inc. (Takasu Factory) has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Marukai Foods Co., Inc. (Takasu Factory), the most recent on Jul 14, 2014.

What these totals cover: FDA records filed under the name "Marukai Foods Co., Inc. (Takasu Factory)".

Latest inspection: Feb 20, 2014 · OAI

Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	0	Nov 11, 2026 (checked Nov 15, 2026, unchanged)	File dated Nov 10, 2026	Current
510(k) clearances	0	Nov 15, 2026	File dated Nov 9, 2026	Current
Inspections	1	Nov 15, 2026	Newest record Nov 5, 2026	Current
Compliance actions	1	Nov 2, 2026	Newest record Oct 29, 2026	Current

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Marukai Foods Co., Inc. (Takasu Factory) FDA Warning Letters

1 warning letter on Jul 14, 2014.

Issued	Subject	Issuing office	Close-out letter
Jul 14, 2014 · Record page

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

1 inspection on Feb 20, 2014.

Date	Site	Product	Classification	FEI
Feb 20, 2014	Onomichi, Japan	Food/Cosmetics	Official Action Indicated (OAI)	3009485928

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 Marukai Foods Co., Inc. (Takasu Factory): warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Jul 14, 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 3009485928	Onomichi, Japan	1	Feb 20, 2014

Marukai Foods Co., Inc. (Takasu Factory) and the FDA: common questions

Has Marukai Foods Co., Inc. (Takasu Factory) received an FDA warning letter?

Yes. FDA has issued 1 warning letter to Marukai Foods Co., Inc. (Takasu Factory). The most recent is dated Jul 14, 2014.

Has Marukai Foods Co., Inc. (Takasu Factory) received an FDA Form 483?

FDA has not published a Form 483 for "Marukai Foods Co., Inc. (Takasu Factory)" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Marukai Foods Co., Inc. (Takasu Factory)?

The most recent FDA inspection on file ended Feb 20, 2014 at Onomichi, Japan and was classified OAI. FDA has 1 inspection of Marukai Foods Co., Inc. (Takasu Factory) on file, 1 of them classified OAI (official action indicated).

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