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Wenzhu Union Eyewear Co., Ltd

✅ Low Risk

FEI: 3007521320 • Wenzhou, Zhejiang • CHINA

FEI

FEI Number

3007521320

📍

Location

Wenzhou, Zhejiang

🇨🇳

Country

CHINA
🏢

Address

2#Wenzhou #2, 325011 Avenue; Shuitouzhen Pingyangxian, Wenzhou, Zhejiang, China

Low Risk

FDA Import Risk Assessment

22.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
2
Unique Violations
11/16/2011
Latest Refusal
11/16/2011
Earliest Refusal

Score Breakdown

Violation Severity
45.0×40%
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.

3411×

REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

Refusal History

DateProductViolationsDivision
11/16/2011
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
235NOT IMPACT
341REGISTERED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Wenzhu Union Eyewear Co., Ltd's FDA import refusal history?

Wenzhu Union Eyewear Co., Ltd (FEI: 3007521320) has 1 FDA import refusal record(s) in our database, spanning from 11/16/2011 to 11/16/2011.

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. Wenzhu Union Eyewear Co., Ltd's FEI number is 3007521320.

What types of violations has Wenzhu Union Eyewear Co., Ltd received?

Wenzhu Union Eyewear Co., Ltd has been cited for 2 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 Wenzhu Union Eyewear Co., Ltd come from?

All FDA import refusal data for Wenzhu Union Eyewear 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.