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Gentex Optics, Inc.

⚠️ Moderate Risk

FEI: 1215866 • Dudley, MA • UNITED STATES

FEI

FEI Number

1215866

📍

Location

Dudley, MA

🇺🇸
🏢

Address

183 W Main St, , Dudley, MA, United States

Moderate Risk

FDA Import Risk Assessment

37.6
LowModerateHighCritical

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

Statistics

5
Total Refusals
1
Unique Violations
3/22/2017
Latest Refusal
3/22/2017
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
Refusal Volume
28.8×30%
Recency
0.0×20%
Frequency
50.0×10%
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

2355×

NOT IMPACT

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

Refusal History

DateProductViolationsDivision
3/22/2017
86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION)
235NOT IMPACT
New Orleans District Office (NOL-DO)
3/22/2017
86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION)
235NOT IMPACT
New Orleans District Office (NOL-DO)
3/22/2017
86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION)
235NOT IMPACT
New Orleans District Office (NOL-DO)
3/22/2017
86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION)
235NOT IMPACT
New Orleans District Office (NOL-DO)
3/22/2017
86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION)
235NOT IMPACT
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Gentex Optics, Inc.'s FDA import refusal history?

Gentex Optics, Inc. (FEI: 1215866) has 5 FDA import refusal record(s) in our database, spanning from 3/22/2017 to 3/22/2017.

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. Gentex Optics, Inc.'s FEI number is 1215866.

What types of violations has Gentex Optics, Inc. received?

Gentex Optics, Inc. 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 Gentex Optics, Inc. come from?

All FDA import refusal data for Gentex Optics, Inc. 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.