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Dongguan Wellko Shoes Factory Limited

⚠️ Moderate Risk

FEI: 3003387944 • Guangdong • CHINA

FEI

FEI Number

3003387944

📍

Location

Guangdong

🇨🇳

Country

CHINA
🏢

Address

Dongguan City, , Guangdong, , China

Moderate Risk

FDA Import Risk Assessment

25.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
6/18/2013
Latest Refusal
6/18/2013
Earliest Refusal

Score Breakdown

Violation Severity
45.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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
6/18/2013
86HQZFRAME, SPECTACLE
341REGISTERED
Los Angeles District Office (LOS-DO)
6/18/2013
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
235NOT IMPACT
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Dongguan Wellko Shoes Factory Limited's FDA import refusal history?

Dongguan Wellko Shoes Factory Limited (FEI: 3003387944) has 2 FDA import refusal record(s) in our database, spanning from 6/18/2013 to 6/18/2013.

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. Dongguan Wellko Shoes Factory Limited's FEI number is 3003387944.

What types of violations has Dongguan Wellko Shoes Factory Limited received?

Dongguan Wellko Shoes Factory Limited 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 Dongguan Wellko Shoes Factory Limited come from?

All FDA import refusal data for Dongguan Wellko Shoes Factory Limited 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.