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Elegance Optical Mfy

⚠️ Moderate Risk

FEI: 3006564735 • Shenzhen • CHINA

FEI

FEI Number

3006564735

📍

Location

Shenzhen

🇨🇳

Country

CHINA
🏢

Address

No 1 Road Thre Jin Quan Industrial, , Shenzhen, , China

Moderate Risk

FDA Import Risk Assessment

33.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
1
Unique Violations
3/4/2015
Latest Refusal
3/4/2015
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

2313×

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
3/4/2015
86HOISPECTACLE, MAGNIFYING
231LENS CERT
Los Angeles District Office (LOS-DO)
3/4/2015
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
231LENS CERT
Los Angeles District Office (LOS-DO)
3/4/2015
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
231LENS CERT
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Elegance Optical Mfy's FDA import refusal history?

Elegance Optical Mfy (FEI: 3006564735) has 3 FDA import refusal record(s) in our database, spanning from 3/4/2015 to 3/4/2015.

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. Elegance Optical Mfy's FEI number is 3006564735.

What types of violations has Elegance Optical Mfy received?

Elegance Optical Mfy 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 Elegance Optical Mfy come from?

All FDA import refusal data for Elegance Optical Mfy 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.