Home / Facilities / 3002807019

FUKUDA DENSHI CO., LTD. FDA Inspection Record

FEI 3002807019 · Inspections, Form 483s, warning letters and import refusals

FUKUDA DENSHI CO., LTD. is an FDA-registered facility (FEI 3002807019) located in Bunkyo-ku T?ky?, JP. RegDataLab tracks 4 FDA inspections at this facility.

What FDA found at this site

Latest inspection
Apr 10, 2025: Voluntary Action Indicated (VAI)
Inspections on record
4 (1 VAI, 3 NAI)
Last OAI inspection
None on record
Warning letters
None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
Recalls as the recalling firm
1, latest Oct 16, 2017

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Newest first. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
Apr 10, 2025Voluntary Action Indicated (VAI)No citations listed
Aug 2, 2018No Action Indicated (NAI)No citations listed
Jan 24, 2013No Action Indicated (NAI)No citations listed
Jun 4, 2009No Action Indicated (NAI)Uniform and timely processing (21 CFR 820.198(a)(1))
Documentation (21 CFR 820.100(b))

Recalls

Newest first. Recalls FDA's Enforcement Report lists with this FEI as the recalling firm. The recalling firm is not always the site that made the product. Search FDA's Enforcement Report by recall number.

DateClassRecallProduct and reason
Oct 16, 2017Class IIZ-0203-2018Fukuda Denshi patient monitor model DS-8100M and DS-8100N Product Usage: Use of the…
For the Fukuda Denshi patient monitor model DS-8100, in less than 0.003% (17) of the 6227 devices sold worldwide, a Short-term Battery…

When each source was last refreshed

FDA sources behind this page and when RegDataLab last refreshed each one
RecordsLast refreshedSource as ofStatus
InspectionsNov 14, 2026Newest record Nov 5, 2026Current
Inspection citationsNov 14, 2026Newest record Nov 5, 2026Current
Compliance actions (warning letters, injunctions and other action types)Nov 2, 2026Newest record Oct 29, 2026Current
Warning letter textNov 14, 2026Newest record Nov 10, 2026Current
Recalls (Enforcement Report)Nov 14, 2026Newest record Nov 11, 2026Current
Form 483s and inspection documentsNov 13, 2026Newest record Nov 12, 2026Current
Import refusalsNov 2, 2026Newest record Oct 22, 2026Current

Reviewing FUKUDA DENSHI CO., LTD. as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.

Check this supplier

Or check FUKUDA DENSHI CO., LTD. yourself in Claude, Cursor or ChatGPT: get the full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site.

Get a free API key

Facility details

Company
Fukuda Denshi Co., Ltd.
Location
Bunkyo-ku T?ky? (JP)
Source
device

FDA data resources

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