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Irlen Center

⚠️ Moderate Risk

FEI: 3003617057 • Wetter (Ruhr), North Rhine-Westphalia • GERMANY

FEI

FEI Number

3003617057

📍

Location

Wetter (Ruhr), North Rhine-Westphalia

🇩🇪

Country

GERMANY
🏢

Address

Amundsenstr. 37, , Wetter (Ruhr), North Rhine-Westphalia, Germany

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
6/5/2006
Latest Refusal
6/5/2006
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

2351×

NOT IMPACT

The article appears to not have impact-resistant lenses in accordance with 21 CFR 801.410.

Refusal History

DateProductViolationsDivision
6/5/2006
86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION)
235NOT IMPACT
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Irlen Center's FDA import refusal history?

Irlen Center (FEI: 3003617057) has 1 FDA import refusal record(s) in our database, spanning from 6/5/2006 to 6/5/2006.

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. Irlen Center's FEI number is 3003617057.

What types of violations has Irlen Center received?

Irlen Center 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 Irlen Center come from?

All FDA import refusal data for Irlen Center 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.