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Yahorng Electronics

⚠️ Moderate Risk

FEI: 3005914320 • An Ding Hgiang • TAIWAN

FEI

FEI Number

3005914320

📍

Location

An Ding Hgiang

🇹🇼

Country

TAIWAN
🏢

Address

35 Sha Lung Chung Sha Tsung, , An Ding Hgiang, , Taiwan

Moderate Risk

FDA Import Risk Assessment

25.7
LowModerateHighCritical

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

Statistics

1
Total Refusals
3
Unique Violations
5/12/2010
Latest Refusal
5/12/2010
Earliest Refusal

Score Breakdown

Violation Severity
53.3×40%
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.

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).

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
5/12/2010
74DXNSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
223FALSE
341REGISTERED
479DV QUALITY
Seattle District Office (SEA-DO)

Frequently Asked Questions

What is Yahorng Electronics's FDA import refusal history?

Yahorng Electronics (FEI: 3005914320) has 1 FDA import refusal record(s) in our database, spanning from 5/12/2010 to 5/12/2010.

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. Yahorng Electronics's FEI number is 3005914320.

What types of violations has Yahorng Electronics received?

Yahorng Electronics has been cited for 3 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 Yahorng Electronics come from?

All FDA import refusal data for Yahorng Electronics 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.