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Winnertek Co.Ltd.

⚠️ Moderate Risk

FEI: 3010424465 • Seoul • SOUTH KOREA

FEI

FEI Number

3010424465

📍

Location

Seoul

🇰🇷
🏢

Address

47-4 Myeongil-Dong, , Seoul, , South Korea

Moderate Risk

FDA Import Risk Assessment

32.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
12/5/2013
Latest Refusal
12/5/2013
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
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

471×

NON STD

The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.

Refusal History

DateProductViolationsDivision
12/5/2013
95RFELASER CUTTER, MATERIAL PROCESSING LASER PRODUCTS
47NON STD
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Winnertek Co.Ltd.'s FDA import refusal history?

Winnertek Co.Ltd. (FEI: 3010424465) has 1 FDA import refusal record(s) in our database, spanning from 12/5/2013 to 12/5/2013.

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. Winnertek Co.Ltd.'s FEI number is 3010424465.

What types of violations has Winnertek Co.Ltd. received?

Winnertek 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 Winnertek Co.Ltd. come from?

All FDA import refusal data for Winnertek 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.