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Assembleon Hong Kong Ltd.

⚠️ Moderate Risk

FEI: 3006175923 • Hong Kong • HONG KONG

FEI

FEI Number

3006175923

📍

Location

Hong Kong

🇭🇰

Country

HONG KONG
🏢

Address

Rm 507-511 5/F The Gateway, , Hong Kong, , Hong Kong

Moderate Risk

FDA Import Risk Assessment

28.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
5/16/2007
Latest Refusal
5/16/2007
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
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

4761×

NO REGISTR

The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).

Refusal History

DateProductViolationsDivision
5/16/2007
95L22LASER PRODUCT FOR NON-MEDICAL USE
476NO REGISTR
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Assembleon Hong Kong Ltd.'s FDA import refusal history?

Assembleon Hong Kong Ltd. (FEI: 3006175923) has 1 FDA import refusal record(s) in our database, spanning from 5/16/2007 to 5/16/2007.

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. Assembleon Hong Kong Ltd.'s FEI number is 3006175923.

What types of violations has Assembleon Hong Kong Ltd. received?

Assembleon Hong Kong 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 Assembleon Hong Kong Ltd. come from?

All FDA import refusal data for Assembleon Hong Kong 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.