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The Canon Zhongshan Business Machines Co. Ltd.

⚠️ Moderate Risk

FEI: 3004045903 • Guangdong • CHINA

FEI

FEI Number

3004045903

📍

Location

Guangdong

🇨🇳

Country

CHINA
🏢

Address

No.26 Huoju, , Zhongshan, Guangdong, , China

Moderate Risk

FDA Import Risk Assessment

36.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
9/8/2003
Latest Refusal
9/8/2003
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
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

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
9/8/2003
95L30LASER PRINTERS
126FAILS STD
Florida District Office (FLA-DO)

Frequently Asked Questions

What is The Canon Zhongshan Business Machines Co. Ltd.'s FDA import refusal history?

The Canon Zhongshan Business Machines Co. Ltd. (FEI: 3004045903) has 1 FDA import refusal record(s) in our database, spanning from 9/8/2003 to 9/8/2003.

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. The Canon Zhongshan Business Machines Co. Ltd.'s FEI number is 3004045903.

What types of violations has The Canon Zhongshan Business Machines Co. Ltd. received?

The Canon Zhongshan Business Machines Co. Ltd. has been cited for 1 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 The Canon Zhongshan Business Machines Co. Ltd. come from?

All FDA import refusal data for The Canon Zhongshan Business Machines Co. Ltd. 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.