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Shenzhen Wei Ye Glasses Factory

⚠️ Moderate Risk

FEI: 3005216781 • Shenzhen • CHINA

FEI

FEI Number

3005216781

📍

Location

Shenzhen

🇨🇳

Country

CHINA
🏢

Address

The Fifth Vidgepole, Up And Down, Fence Ind. Estate, Baoan Vill., Henggang, Shenzhen, , China

Moderate Risk

FDA Import Risk Assessment

42.7
LowModerateHighCritical

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

Statistics

12
Total Refusals
2
Unique Violations
10/4/2012
Latest Refusal
8/23/2011
Earliest Refusal

Score Breakdown

Violation Severity
50.8×40%
Refusal Volume
41.3×30%
Recency
0.0×20%
Frequency
100.0×10%
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

11812×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

2351×

NOT IMPACT

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

Refusal History

DateProductViolationsDivision
10/4/2012
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
118NOT LISTED
Detroit District Office (DET-DO)
4/9/2012
86HQZFRAME, SPECTACLE
118NOT LISTED
Detroit District Office (DET-DO)
4/9/2012
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
118NOT LISTED
Detroit District Office (DET-DO)
12/19/2011
86HQZFRAME, SPECTACLE
118NOT LISTED
Detroit District Office (DET-DO)
12/19/2011
86HQZFRAME, SPECTACLE
118NOT LISTED
Detroit District Office (DET-DO)
12/19/2011
86HQZFRAME, SPECTACLE
118NOT LISTED
Detroit District Office (DET-DO)
12/19/2011
86HQZFRAME, SPECTACLE
118NOT LISTED
Detroit District Office (DET-DO)
12/19/2011
86HQZFRAME, SPECTACLE
118NOT LISTED
Detroit District Office (DET-DO)
12/19/2011
86HQZFRAME, SPECTACLE
118NOT LISTED
Detroit District Office (DET-DO)
12/19/2011
86HQZFRAME, SPECTACLE
118NOT LISTED
Detroit District Office (DET-DO)
8/23/2011
86HQZFRAME, SPECTACLE
118NOT LISTED
New Orleans District Office (NOL-DO)
8/23/2011
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
118NOT LISTED
235NOT IMPACT
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Shenzhen Wei Ye Glasses Factory's FDA import refusal history?

Shenzhen Wei Ye Glasses Factory (FEI: 3005216781) has 12 FDA import refusal record(s) in our database, spanning from 8/23/2011 to 10/4/2012.

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. Shenzhen Wei Ye Glasses Factory's FEI number is 3005216781.

What types of violations has Shenzhen Wei Ye Glasses Factory received?

Shenzhen Wei Ye Glasses Factory 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 Shenzhen Wei Ye Glasses Factory come from?

All FDA import refusal data for Shenzhen Wei Ye Glasses Factory 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.