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Canon Inc.

⚠️ Moderate Risk

FEI: 1000181430 • Kawasaki, Kanagawa • JAPAN

FEI

FEI Number

1000181430

📍

Location

Kawasaki, Kanagawa

🇯🇵

Country

JAPAN
🏢

Address

9-1, Imaikami-cho, Nakahara-ku, , Kawasaki, Kanagawa, Japan

Moderate Risk

FDA Import Risk Assessment

25.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
2
Unique Violations
8/25/2011
Latest Refusal
2/24/2003
Earliest Refusal

Score Breakdown

Violation Severity
46.7×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
3.5×10%
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

3412×

REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

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
8/25/2011
86HLMINSTRUMENT, MEASURING, LENS, AC-POWERED
341REGISTERED
Detroit District Office (DET-DO)
8/25/2011
86HKNREFRACTOR, MANUAL, NON-POWERED, INCLUDING PHOROPTER
341REGISTERED
Detroit District Office (DET-DO)
2/24/2003
95L30LASER PRINTERS
126FAILS STD
Atlanta District Office (ATL-DO)

Frequently Asked Questions

What is Canon Inc.'s FDA import refusal history?

Canon Inc. (FEI: 1000181430) has 3 FDA import refusal record(s) in our database, spanning from 2/24/2003 to 8/25/2011.

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 1000181430.

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.