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Orion Electric Co. Ltd.

⚠️ Moderate Risk

FEI: 1838 • Kyung Buk • SOUTH KOREA

FEI

FEI Number

1838

📍

Location

Kyung Buk

🇰🇷
🏢

Address

697 Shinbu Dong, Gumi Eup, Sunsan-Gun,, Kyung Buk, , South Korea

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
3/19/2003
Latest Refusal
3/19/2003
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
3/19/2003
94V05CATHODE RAY TUBE
476NO REGISTR
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

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

Orion Electric Co. Ltd. (FEI: 1838) has 1 FDA import refusal record(s) in our database, spanning from 3/19/2003 to 3/19/2003.

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. Orion Electric Co. Ltd.'s FEI number is 1838.

What types of violations has Orion Electric Co. Ltd. received?

Orion Electric 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 Orion Electric Co. Ltd. come from?

All FDA import refusal data for Orion Electric 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.