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CHU KONG OPTICAL MANUFACTORY LIM

⚠️ Moderate Risk

FEI: 3012306440 • Kwai Chung, New Territories • HONG KONG

FEI

FEI Number

3012306440

📍

Location

Kwai Chung, New Territories

🇭🇰

Country

HONG KONG
🏢

Address

Regent Centre Tower A, 63 Wo Yi Hop Road, Kwai Chung, New Territories, Hong Kong

Moderate Risk

FDA Import Risk Assessment

30.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
2
Unique Violations
10/14/2008
Latest Refusal
10/14/2008
Earliest Refusal

Score Breakdown

Violation Severity
52.5×40%
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

1183×

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
10/14/2008
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
118NOT LISTED
235NOT IMPACT
Chicago District Office (CHI-DO)
10/14/2008
86HQZFRAME, SPECTACLE
118NOT LISTED
Chicago District Office (CHI-DO)
10/14/2008
86HQZFRAME, SPECTACLE
118NOT LISTED
Chicago District Office (CHI-DO)

Frequently Asked Questions

What is CHU KONG OPTICAL MANUFACTORY LIM's FDA import refusal history?

CHU KONG OPTICAL MANUFACTORY LIM (FEI: 3012306440) has 3 FDA import refusal record(s) in our database, spanning from 10/14/2008 to 10/14/2008.

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. CHU KONG OPTICAL MANUFACTORY LIM's FEI number is 3012306440.

What types of violations has CHU KONG OPTICAL MANUFACTORY LIM received?

CHU KONG OPTICAL MANUFACTORY LIM 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 CHU KONG OPTICAL MANUFACTORY LIM come from?

All FDA import refusal data for CHU KONG OPTICAL MANUFACTORY LIM 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.