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GE Healthcare Japan Corporation FDA Inspection Record

FEI 3002808529 · Inspections, Form 483s, warning letters and import refusals

GE Healthcare Japan Corporation is an FDA-registered facility (FEI 3002808529) located in HINO-SHI T?ky?, JP. RegDataLab tracks 3 FDA inspections at this facility.

What FDA found at this site

Latest inspection
Dec 15, 2017: No Action Indicated (NAI)
Inspections on record
3 (1 VAI, 2 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 Apr 27, 2018
Import refusals
10 or more

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
Dec 15, 2017No Action Indicated (NAI)No citations listed
May 21, 2015No Action Indicated (NAI)Design review - Lack of or inadequate procedures (21 CFR 820.30(e))
Apr 5, 2012Voluntary Action Indicated (VAI)Lack of or inadequate complaint procedures (21 CFR 820.198(a))
Lack of or inadequate procedures (21 CFR 820.100(a))
DHR content (21 CFR 820.184)
Investigation of device failures (21 CFR 820.198(c))

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
Apr 27, 2018Class IIZ-2870-2018GE Healthcare Revolution EVO, Optima CT660, Optima CT670, Optima CT680. The systems are… and 3 more products
GE Healthcare has identified that some CT systems may have a damaged cable that can expose 120VAC to Service Engineers working inside the…

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
GE Healthcare Japan Corporation
Location
HINO-SHI T?ky? (JP)
Source
device

Import refusals

FDA data resources

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