ImportRefusal LogoImportRefusal

Ablecom Technology

⚠️ Moderate Risk

FEI: 3006370079 • Taipei • TAIWAN

FEI

FEI Number

3006370079

📍

Location

Taipei

🇹🇼

Country

TAIWAN
🏢

Address

228 Lian Cheng, , Taipei, , Taiwan

Moderate Risk

FDA Import Risk Assessment

36.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
4/8/2009
Latest Refusal
4/8/2009
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
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

1261×

FAILS STD

The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.

Refusal History

DateProductViolationsDivision
4/8/2009
95RFWDVD, DVD-ROM PLAYER, LASER UTILITY/PERIPHERAL LASER PRODUCTS
126FAILS STD
San Francisco District Office (SAN-DO)

Frequently Asked Questions

What is Ablecom Technology's FDA import refusal history?

Ablecom Technology (FEI: 3006370079) has 1 FDA import refusal record(s) in our database, spanning from 4/8/2009 to 4/8/2009.

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. Ablecom Technology's FEI number is 3006370079.

What types of violations has Ablecom Technology received?

Ablecom Technology 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 Ablecom Technology come from?

All FDA import refusal data for Ablecom Technology 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.