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WENZHOU EYESTAR EYEWEAR CO., LTD

⚠️ Moderate Risk

FEI: 3013603033 • Wenzhou, Zhejiang • CHINA

FEI

FEI Number

3013603033

📍

Location

Wenzhou, Zhejiang

🇨🇳

Country

CHINA
🏢

Address

Building A3 Ouhai Headquarter Fl 12, Louqiao, Wenzhou, Zhejiang, China

Moderate Risk

FDA Import Risk Assessment

26.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
9/23/2020
Latest Refusal
9/23/2020
Earliest Refusal

Score Breakdown

Violation Severity
55.0×40%
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.

32801×

FRNMFGREG

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.

Refusal History

DateProductViolationsDivision
9/23/2020
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
235NOT IMPACT
3280FRNMFGREG
Division of West Coast Imports (DWCI)

Frequently Asked Questions

What is WENZHOU EYESTAR EYEWEAR CO., LTD's FDA import refusal history?

WENZHOU EYESTAR EYEWEAR CO., LTD (FEI: 3013603033) has 1 FDA import refusal record(s) in our database, spanning from 9/23/2020 to 9/23/2020.

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. WENZHOU EYESTAR EYEWEAR CO., LTD's FEI number is 3013603033.

What types of violations has WENZHOU EYESTAR EYEWEAR CO., LTD received?

WENZHOU EYESTAR 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 WENZHOU EYESTAR EYEWEAR CO., LTD come from?

All FDA import refusal data for WENZHOU EYESTAR 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.