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Neo Optical Co Ltd

⚠️ Moderate Risk

FEI: 3010745524 • Yen Dung • VIETNAM

FEI

FEI Number

3010745524

📍

Location

Yen Dung

🇻🇳

Country

VIETNAM
🏢

Address

Neo District Industrial Zone, , Yen Dung, , Vietnam

Moderate Risk

FDA Import Risk Assessment

33.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
1
Unique Violations
10/31/2017
Latest Refusal
10/31/2017
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

2353×

NOT IMPACT

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

Refusal History

DateProductViolationsDivision
10/31/2017
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
235NOT IMPACT
Division of Northeast Imports (DNEI)
10/31/2017
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
235NOT IMPACT
Division of Northeast Imports (DNEI)
10/31/2017
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
235NOT IMPACT
Division of Northeast Imports (DNEI)

Frequently Asked Questions

What is Neo Optical Co Ltd's FDA import refusal history?

Neo Optical Co Ltd (FEI: 3010745524) has 3 FDA import refusal record(s) in our database, spanning from 10/31/2017 to 10/31/2017.

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. Neo Optical Co Ltd's FEI number is 3010745524.

What types of violations has Neo Optical Co Ltd received?

Neo Optical Co Ltd 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 Neo Optical Co Ltd come from?

All FDA import refusal data for Neo Optical Co Ltd 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.