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Kanebo Cosmetics Inc. FDA Record

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

Latest inspection OAI · Sep 6, 2012
Last warning letter 2013

Inspections 1

1 OAI

Recalls 0 0 Class I

Warning letters 1 Latest Apr 1, 2013

510(k) clearances 0 None on file

Kanebo Cosmetics Inc. has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Kanebo Cosmetics Inc., the most recent on Apr 1, 2013.

What these totals cover: FDA records filed under the name "Kanebo Cosmetics Inc." and its spelling variant "Kanebo Cosmetics".

Latest inspection: Sep 6, 2012 · 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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Kanebo Cosmetics Inc. FDA Warning Letters

1 warning letter on Apr 1, 2013.

Issued	Subject	Issuing office	Close-out letter
Apr 1, 2013 · 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 Sep 6, 2012.

Date	Site	Product	Classification	FEI
Sep 6, 2012	Odawara, Japan	Drugs	Official Action Indicated (OAI)	3003411215

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 Kanebo Cosmetics Inc.: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Apr 1, 2013.

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 3003411215	Odawara, Japan	1	Sep 6, 2012

Kanebo Cosmetics Inc. and the FDA: common questions

Has Kanebo Cosmetics Inc. received an FDA warning letter?

Yes. FDA has issued 1 warning letter to Kanebo Cosmetics Inc.. The most recent is dated Apr 1, 2013.

Has Kanebo Cosmetics Inc. received an FDA Form 483?

FDA has not published a Form 483 for "Kanebo Cosmetics Inc." in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Kanebo Cosmetics Inc.?

The most recent FDA inspection on file ended Sep 6, 2012 at Odawara, Japan and was classified OAI. FDA has 1 inspection of Kanebo Cosmetics Inc. on file, 1 of them classified OAI (official action indicated).

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