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OMRON HEALTHCARE CO., LTD. FDA Inspection Record

FEI 3004072282 · Inspections, Form 483s, warning letters and import refusals

OMRON HEALTHCARE CO., LTD. is an FDA-registered facility (FEI 3004072282) located in MUKO Ky?to, JP. RegDataLab tracks 3 FDA inspections at this facility.

What FDA found at this site

Latest inspection
Feb 27, 2018: No Action Indicated (NAI)
Inspections on record
3 (2 VAI, 1 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
Import refusals
4

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
Feb 27, 2018No Action Indicated (NAI)No citations listed
May 29, 2015Voluntary Action Indicated (VAI)Design review - documentation (21 CFR 820.30(e))
Not approved or obsolete document retrieval (21 CFR 820.40(a))
Sep 29, 2011Voluntary Action Indicated (VAI)Lack of or inadequate complaint procedures (21 CFR 820.198(a))
Quality plan (21 CFR 820.20(d))
Lack of or inadequate procedures (21 CFR 820.100(a))
Lack of System for Determining MDR Events (21 CFR 803.17(a)(2))

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

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Facility details

Company
Omron Healthcare Co., Ltd.
Location
MUKO Ky?to (JP)
Source
device

Import refusals

FDA data resources

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