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Elegance Optical Manufactory, Ltd.

✅ Low Risk

FEI: 3909 • Kwun Tong, Kowloon • HONG KONG

FEI

FEI Number

3909

📍

Location

Kwun Tong, Kowloon

🇭🇰

Country

HONG KONG
🏢

Address

8/F, Mai Hing Industrial Building Block B; 16-18 Hing Yip Street, Kwun Tong, Kowloon, Hong Kong

Low Risk

FDA Import Risk Assessment

17.8
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

2
Total Refusals
1
Unique Violations
10/2/2008
Latest Refusal
10/25/2004
Earliest Refusal

Score Breakdown

Violation Severity
30.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
5.1×10%
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

3412×

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
10/2/2008
86HQZFRAME, SPECTACLE
341REGISTERED
Florida District Office (FLA-DO)
10/25/2004
86HQZFRAME, SPECTACLE
341REGISTERED
New York District Office (NYK-DO)

Frequently Asked Questions

What is Elegance Optical Manufactory, Ltd.'s FDA import refusal history?

Elegance Optical Manufactory, Ltd. (FEI: 3909) has 2 FDA import refusal record(s) in our database, spanning from 10/25/2004 to 10/2/2008.

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 Manufactory, Ltd.'s FEI number is 3909.

What types of violations has Elegance Optical Manufactory, Ltd. received?

Elegance Optical Manufactory, Ltd. 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 Manufactory, Ltd. come from?

All FDA import refusal data for Elegance Optical Manufactory, 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.