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Canon Opto(Malaysia) Snd.Bhd

⚠️ Moderate Risk

FEI: 3004120160 • Alam Selangor Darul Ehs • MALAYSIA

FEI

FEI Number

3004120160

📍

Location

Alam Selangor Darul Ehs

🇲🇾

Country

MALAYSIA
🏢

Address

Jalan Selisik, Sksyen 26,40000 Shah, , Alam Selangor Darul Ehs, , Malaysia

Moderate Risk

FDA Import Risk Assessment

32.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
9/23/2003
Latest Refusal
9/23/2003
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
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

471×

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.

Refusal History

DateProductViolationsDivision
9/23/2003
97U09ULTRASOUND PRODUCT FOR NON-MEDICAL USE
47NON STD
Florida District Office (FLA-DO)

Frequently Asked Questions

What is Canon Opto(Malaysia) Snd.Bhd's FDA import refusal history?

Canon Opto(Malaysia) Snd.Bhd (FEI: 3004120160) has 1 FDA import refusal record(s) in our database, spanning from 9/23/2003 to 9/23/2003.

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. Canon Opto(Malaysia) Snd.Bhd's FEI number is 3004120160.

What types of violations has Canon Opto(Malaysia) Snd.Bhd received?

Canon Opto(Malaysia) Snd.Bhd 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 Canon Opto(Malaysia) Snd.Bhd come from?

All FDA import refusal data for Canon Opto(Malaysia) Snd.Bhd 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.