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ARKRAY, INC. FDA Inspection Record

FEI 3002807423 · Inspections, Form 483s, warning letters and import refusals

ARKRAY, INC. is an FDA-registered facility (FEI 3002807423) located in Kamigyo-ku Ky?to, JP. RegDataLab tracks 3 FDA inspections and 1 compliance action at this facility.

What FDA found at this site

Latest inspection
Oct 10, 2014: Official Action Indicated (OAI)
Inspections on record
3 (1 OAI, 2 NAI)
Last OAI inspection
Oct 10, 2014
Warning letters
1 listed by FDA for this FEI, latest Apr 10, 2015
Import refusals
2

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
Oct 10, 2014Official Action Indicated (OAI)Design review - Lack of or inadequate procedures (21 CFR 820.30(e))
Design verification - Lack of or inadequate procedures (21 CFR 820.30(f))
Design validation- Lack of or inadequate procedures (21 CFR 820.30(g))
Design transfer - Lack of or inadequate procedures (21 CFR 820.30(h))
and 2 more
Aug 2, 2011No Action Indicated (NAI)No citations listed
Feb 9, 2009No Action Indicated (NAI)No citations listed

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
ARKRAY, Inc.
Location
Kamigyo-ku Ky?to (JP)
Source
device

Compliance actions

Import refusals

FDA data resources

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