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Canon Inc

⚠️ Moderate Risk

FEI: 1000128466 • Toride, Ibaraki • JAPAN

FEI

FEI Number

1000128466

📍

Location

Toride, Ibaraki

🇯🇵

Country

JAPAN
🏢

Address

Toridejigyosho, 5-1, HAKUSAN 7-CHOME, TORIDE-SHI, Toride, Ibaraki, Japan

Moderate Risk

FDA Import Risk Assessment

50.0
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

10
Total Refusals
2
Unique Violations
4/16/2004
Latest Refusal
8/7/2003
Earliest Refusal

Score Breakdown

Violation Severity
71.0×40%
Refusal Volume
38.6×30%
Recency
0.0×20%
Frequency
100.0×10%
How is this score calculated?

Proprietary Algorithm

  • 40% Violation Severity — AI-assessed (1-10)
  • 30% Refusal Volume — Logarithmic scale
  • 20% Recency — Decays over 5 years
  • 10% Frequency — Refusals per year

© ImportRefusal.com Original Analysis

Violation Summary

479×

NON STD

The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.

1261×

FAILS STD

The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.

Refusal History

DateProductViolationsDivision
4/16/2004
95L30LASER PRINTERS
47NON STD
Florida District Office (FLA-DO)
11/19/2003
95L30LASER PRINTERS
47NON STD
Florida District Office (FLA-DO)
10/30/2003
95L30LASER PRINTERS
47NON STD
Florida District Office (FLA-DO)
10/30/2003
95L30LASER PRINTERS
47NON STD
Florida District Office (FLA-DO)
10/17/2003
95L30LASER PRINTERS
47NON STD
Florida District Office (FLA-DO)
10/17/2003
95L30LASER PRINTERS
47NON STD
Florida District Office (FLA-DO)
9/10/2003
95L30LASER PRINTERS
47NON STD
Florida District Office (FLA-DO)
9/10/2003
95L30LASER PRINTERS
47NON STD
Florida District Office (FLA-DO)
9/8/2003
95L30LASER PRINTERS
126FAILS STD
Florida District Office (FLA-DO)
8/7/2003
95L30LASER PRINTERS
47NON STD
Florida District Office (FLA-DO)

Frequently Asked Questions

What is Canon Inc's FDA import refusal history?

Canon Inc (FEI: 1000128466) has 10 FDA import refusal record(s) in our database, spanning from 8/7/2003 to 4/16/2004.

What is an FEI number?

FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Canon Inc's FEI number is 1000128466.

What types of violations has Canon Inc received?

Canon Inc has been cited for 2 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.

Where does this information about Canon Inc come from?

All FDA import refusal data for Canon Inc is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.

Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.