Suzukatsu Co., Ltd FDA Record

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

Suzukatsu 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 Suzukatsu Co., Ltd, the most recent on Feb 13, 2015.

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

Latest inspection
Feb 21, 2019 · NAI

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
Inspections2Nov 14, 2026Newest record Nov 5, 2026Current
Compliance actions1Nov 2, 2026Newest record Oct 29, 2026Current

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Suzukatsu Co., Ltd FDA Warning Letters

1 warning letter on Feb 13, 2015.

IssuedSubjectIssuing officeClose-out letter
Feb 13, 2015

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 Sep 12, 2014 to Feb 21, 2019.

DateSiteProductClassificationFEI
Feb 21, 2019Yaizu, JapanFood/CosmeticsNo Action Indicated (NAI)1000178015
Sep 12, 2014Yaizu, JapanFood/CosmeticsVoluntary Action Indicated (VAI)1000178015
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 Suzukatsu Co., Ltd: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Feb 13, 2015.

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.

FacilityLocationInspectionsLatest
FEI 1000178015Yaizu, Japan2Feb 21, 2019

Suzukatsu Co., Ltd and the FDA: common questions

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

Yes. FDA has issued 1 warning letter to Suzukatsu Co., Ltd. The most recent is dated Feb 13, 2015.

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

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

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

The most recent FDA inspection on file ended Feb 21, 2019 at Yaizu, Japan and was classified NAI. FDA has 2 inspections of Suzukatsu Co., Ltd on file.

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