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CANON INC. FDA Inspection Record

FEI 1000181430 · Inspections, Form 483s, warning letters and import refusals

CANON INC. is an FDA-registered facility (FEI 1000181430) located in Kawasaki Kanagawa, JP. RegDataLab tracks 1 FDA inspection at this facility.

What FDA found at this site

Latest inspection
Sep 17, 2014: No Action Indicated (NAI)
Inspections on record
1 (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
Recalls as the recalling firm
2, latest Dec 5, 2012
Import refusals
3

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
Sep 17, 2014No Action Indicated (NAI)No citations listed

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
Dec 5, 2012Class IIZ-1404-2013Canon Full Auto Ref-Keratometer RK-F2, Catalog Number 6937B002AA. Product Usage: This…
Canon Inc. had received 17 claims from our foreign sales companies between October to November 2012 that measurement value of RK-F2s…
Nov 1, 2010Class IIZ-2265-2012Canon Solid State X-ray Imager (Flat Panel/Digital Imager), Digital Radiography, Models…
Screws holding the 55REF circuit board are loosening and roaming inside of the sealed sensor.

FDA record score

0 of 100. A count of this site's adverse public FDA records, weighted by how recent each one is. A higher number means more, or more recent, records. Each record below adds the points shown.

Counted on Nov 15, 2026, method version 1. It counts records and does not judge the site: a low number does not establish that a site is safe, and sites that FDA inspects more often can collect more points. How this is counted.

2 records behind this number
RecordDatePoints x age weightAdds
Class II recall Z-1404-2013, this FEI as the recalling firmDec 5, 201210 years or older, so it adds no points0
Class II recall Z-2265-2012, this FEI as the recalling firmNov 1, 201010 years or older, so it adds no points0

When each source was last refreshed

FDA sources behind this page and when RegDataLab last refreshed each one
RecordsLast refreshedSource as ofStatus
InspectionsNov 15, 2026Newest record Nov 5, 2026Current
Inspection citationsNov 15, 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 15, 2026Newest record Nov 11, 2026Current
Form 483s and inspection documentsNov 13, 2026Newest record Nov 12, 2026Current
Import refusalsNov 15, 2026Newest record Nov 5, 2026Current

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Facility details

Company
Canon Inc.
Location
Kawasaki Kanagawa (JP)
Source
device

Import refusals

FDA data resources

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