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Ya Horng Electronic Co.,Ltd.

⚠️ Moderate Risk

FEI: 3002597177 • Kowloon • HONG KONG

FEI

FEI Number

3002597177

📍

Location

Kowloon

🇭🇰

Country

HONG KONG
🏢

Address

11-12 Tak Hing Streetrm. 1608, 16/F., , Kowloon, , Hong Kong

Moderate Risk

FDA Import Risk Assessment

30.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
2/1/2010
Latest Refusal
2/1/2010
Earliest Refusal

Score Breakdown

Violation Severity
65.0×40%
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

2231×

FALSE

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.

4791×

DV QUALITY

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be adulterated since its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess.

Refusal History

DateProductViolationsDivision
2/1/2010
74DXNSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
223FALSE
479DV QUALITY
Seattle District Office (SEA-DO)

Frequently Asked Questions

What is Ya Horng Electronic Co.,Ltd.'s FDA import refusal history?

Ya Horng Electronic Co.,Ltd. (FEI: 3002597177) has 1 FDA import refusal record(s) in our database, spanning from 2/1/2010 to 2/1/2010.

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. Ya Horng Electronic Co.,Ltd.'s FEI number is 3002597177.

What types of violations has Ya Horng Electronic Co.,Ltd. received?

Ya Horng Electronic Co.,Ltd. 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 Ya Horng Electronic Co.,Ltd. come from?

All FDA import refusal data for Ya Horng Electronic 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.