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ARTSUN (H.K) INDUSTRIAL CO., LTD.

✅ Low Risk

FEI: 3009302840 • Wan Chai, Hong Kong Island • HONG KONG

FEI

FEI Number

3009302840

📍

Location

Wan Chai, Hong Kong Island

🇭🇰

Country

HONG KONG
🏢

Address

Unit A, 2/F, Trust Tower; 68 Johnston Road, Wan Chai, Hong Kong Island, Hong Kong

Low Risk

FDA Import Risk Assessment

16.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
1/10/2014
Latest Refusal
1/10/2014
Earliest Refusal

Score Breakdown

Violation Severity
30.0×40%
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

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
1/10/2014
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
341REGISTERED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is ARTSUN (H.K) INDUSTRIAL CO., LTD.'s FDA import refusal history?

ARTSUN (H.K) INDUSTRIAL CO., LTD. (FEI: 3009302840) has 1 FDA import refusal record(s) in our database, spanning from 1/10/2014 to 1/10/2014.

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. ARTSUN (H.K) INDUSTRIAL CO., LTD.'s FEI number is 3009302840.

What types of violations has ARTSUN (H.K) INDUSTRIAL CO., LTD. received?

ARTSUN (H.K) INDUSTRIAL CO., 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 ARTSUN (H.K) INDUSTRIAL CO., LTD. come from?

All FDA import refusal data for ARTSUN (H.K) INDUSTRIAL CO., 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.