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Elcan Optical Technologiesiso 9001 Registered

⚠️ Moderate Risk

FEI: 3002171115 • Midland, Ontario • CANADA

FEI

FEI Number

3002171115

📍

Location

Midland, Ontario

🇨🇦

Country

CANADA
🏢

Address

450 Leitz Rd, , Midland, Ontario, 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
12/13/2002
Latest Refusal
12/13/2002
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
12/13/2002
95L22LASER PRODUCT FOR NON-MEDICAL USE
476NO REGISTR
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Elcan Optical Technologiesiso 9001 Registered's FDA import refusal history?

Elcan Optical Technologiesiso 9001 Registered (FEI: 3002171115) has 1 FDA import refusal record(s) in our database, spanning from 12/13/2002 to 12/13/2002.

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. Elcan Optical Technologiesiso 9001 Registered's FEI number is 3002171115.

What types of violations has Elcan Optical Technologiesiso 9001 Registered received?

Elcan Optical Technologiesiso 9001 Registered 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 Elcan Optical Technologiesiso 9001 Registered come from?

All FDA import refusal data for Elcan Optical Technologiesiso 9001 Registered 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.