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Luxottica North America Distribution LLC

⚠️ Moderate Risk

FEI: 3002774493 • Mcdonough, GA • UNITED STATES

FEI

FEI Number

3002774493

📍

Location

Mcdonough, GA

🇺🇸
🏢

Address

100 Greenwood Industrial Pkwy, , Mcdonough, GA, United States

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
10/4/2011
Latest Refusal
10/4/2011
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
10/4/2011
86HQZFRAME, SPECTACLE
235NOT IMPACT
Florida District Office (FLA-DO)

Frequently Asked Questions

What is Luxottica North America Distribution LLC's FDA import refusal history?

Luxottica North America Distribution LLC (FEI: 3002774493) has 1 FDA import refusal record(s) in our database, spanning from 10/4/2011 to 10/4/2011.

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. Luxottica North America Distribution LLC's FEI number is 3002774493.

What types of violations has Luxottica North America Distribution LLC received?

Luxottica North America Distribution LLC 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 Luxottica North America Distribution LLC come from?

All FDA import refusal data for Luxottica North America Distribution LLC 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.