Fukuda Denshi Co., Ltd. FDA Record

Summary

FDA record by year

Fukuda Denshi Co., Ltd.'s FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Inspections are counted by the date they ended, warning letters by the date FDA issued them and recall records by the recall start date. FDA lists one recall record per recalled product, so one recall event can add several.

Fukuda Denshi Co., Ltd. FDA Warning Letters

1 warning letter on Feb 21, 2012.

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 recalls

1 recall record on Oct 16, 2017.

Recent FDA inspections

5 inspections from Jun 4, 2009 to Apr 10, 2025.

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

Most recent: Warning Letter, Feb 21, 2012.

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

2 inspected sites, newest inspection first.

Recent 510(k) clearances

2 510(k) clearances from Sep 9, 2008 to Apr 8, 2011.

Fukuda Denshi Co., Ltd. and the FDA: common questions

Has Fukuda Denshi Co., Ltd. received an FDA warning letter?

Yes. FDA has issued 1 warning letter to Fukuda Denshi Co., Ltd.. The most recent is dated Feb 21, 2012.

Has Fukuda Denshi Co., Ltd. received an FDA Form 483?

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

When did the FDA last inspect Fukuda Denshi Co., Ltd.?

The most recent FDA inspection on file ended Apr 10, 2025 at Bunkyo, Japan and was classified VAI. FDA has 5 inspections of Fukuda Denshi Co., Ltd. on file, 1 of them classified OAI (official action indicated).

Has Fukuda Denshi Co., Ltd. had an FDA recall?

Yes. Fukuda Denshi Co., Ltd. has 1 FDA recall on record. The most recent started Oct 16, 2017.