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Chu Kong Optical Mfy Limited

✅ Low Risk

FEI: 3012185547 • Hong Kong • HONG KONG

FEI

FEI Number

3012185547

📍

Location

Hong Kong

🇭🇰

Country

HONG KONG
🏢

Address

63 Wo Yi Hop Road 852, , Hong Kong, , Hong Kong

Low Risk

FDA Import Risk Assessment

22.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
4/21/2016
Latest Refusal
4/21/2016
Earliest Refusal

Score Breakdown

Violation Severity
45.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
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

2351×

NOT IMPACT

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

3411×

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
4/21/2016
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
235NOT IMPACT
341REGISTERED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Chu Kong Optical Mfy Limited's FDA import refusal history?

Chu Kong Optical Mfy Limited (FEI: 3012185547) has 1 FDA import refusal record(s) in our database, spanning from 4/21/2016 to 4/21/2016.

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. Chu Kong Optical Mfy Limited's FEI number is 3012185547.

What types of violations has Chu Kong Optical Mfy Limited received?

Chu Kong Optical Mfy Limited 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 Mfy Limited come from?

All FDA import refusal data for Chu Kong Optical Mfy Limited 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.