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Gentec Electro-Optique

⚠️ Moderate Risk

FEI: 3003899818 • Quebec, Quebec • CANADA

FEI

FEI Number

3003899818

📍

Location

Quebec, Quebec

🇨🇦

Country

CANADA
🏢

Address

445 Saint-Jean-Baptiste Ave, , Quebec, Quebec, Canada

Moderate Risk

FDA Import Risk Assessment

28.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
12/13/2013
Latest Refusal
12/13/2013
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
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

4761×

NO REGISTR

The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).

Refusal History

DateProductViolationsDivision
12/13/2013
86HLCINSTRUMENT, MEASURING, STEREOPSIS
476NO REGISTR
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Gentec Electro-Optique's FDA import refusal history?

Gentec Electro-Optique (FEI: 3003899818) has 1 FDA import refusal record(s) in our database, spanning from 12/13/2013 to 12/13/2013.

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. Gentec Electro-Optique's FEI number is 3003899818.

What types of violations has Gentec Electro-Optique received?

Gentec Electro-Optique 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 Gentec Electro-Optique come from?

All FDA import refusal data for Gentec Electro-Optique 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.