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Wenzhou Lucheng Bright Glasses

⚠️ Moderate Risk

FEI: 3006374278 • Wenzhou • CHINA

FEI

FEI Number

3006374278

📍

Location

Wenzhou

🇨🇳

Country

CHINA
🏢

Address

139 Yanxing Rd Yanjiang Industri, , Wenzhou, , China

Moderate Risk

FDA Import Risk Assessment

45.6
LowModerateHighCritical

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

Statistics

10
Total Refusals
1
Unique Violations
10/17/2016
Latest Refusal
10/17/2016
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
Refusal Volume
38.6×30%
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

23110×

LENS CERT

The lenses are declared by accompanying certificate to meet the requirements for impact-resistant lenses in 21 CFR 801.410 but does not appear to be impact-resistant.

Refusal History

DateProductViolationsDivision
10/17/2016
86HOISPECTACLE, MAGNIFYING
231LENS CERT
Seattle District Office (SEA-DO)
10/17/2016
86HOISPECTACLE, MAGNIFYING
231LENS CERT
Seattle District Office (SEA-DO)
10/17/2016
86HOISPECTACLE, MAGNIFYING
231LENS CERT
Seattle District Office (SEA-DO)
10/17/2016
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
231LENS CERT
Seattle District Office (SEA-DO)
10/17/2016
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
231LENS CERT
Seattle District Office (SEA-DO)
10/17/2016
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
231LENS CERT
Seattle District Office (SEA-DO)
10/17/2016
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
231LENS CERT
Seattle District Office (SEA-DO)
10/17/2016
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
231LENS CERT
Seattle District Office (SEA-DO)
10/17/2016
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
231LENS CERT
Seattle District Office (SEA-DO)
10/17/2016
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
231LENS CERT
Seattle District Office (SEA-DO)

Frequently Asked Questions

What is Wenzhou Lucheng Bright Glasses's FDA import refusal history?

Wenzhou Lucheng Bright Glasses (FEI: 3006374278) has 10 FDA import refusal record(s) in our database, spanning from 10/17/2016 to 10/17/2016.

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 Lucheng Bright Glasses's FEI number is 3006374278.

What types of violations has Wenzhou Lucheng Bright Glasses received?

Wenzhou Lucheng Bright Glasses 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 Wenzhou Lucheng Bright Glasses come from?

All FDA import refusal data for Wenzhou Lucheng Bright Glasses 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.