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Dong Nam Industries Co Ltd

✅ Low Risk

FEI: 3006161476 • Hwasung City • SOUTH KOREA

FEI

FEI Number

3006161476

📍

Location

Hwasung City

🇰🇷
🏢

Address

1537-4 Namyang Dong, , Hwasung City, , South Korea

Low Risk

FDA Import Risk Assessment

20.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
2
Unique Violations
11/27/2007
Latest Refusal
11/27/2007
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
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

1181×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

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).

Refusal History

DateProductViolationsDivision
11/27/2007
89ILYLAMP, INFRARED, THERAPEUTIC HEATING
118NOT LISTED
341REGISTERED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Dong Nam Industries Co Ltd's FDA import refusal history?

Dong Nam Industries Co Ltd (FEI: 3006161476) has 1 FDA import refusal record(s) in our database, spanning from 11/27/2007 to 11/27/2007.

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. Dong Nam Industries Co Ltd's FEI number is 3006161476.

What types of violations has Dong Nam Industries Co Ltd received?

Dong Nam Industries 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 Dong Nam Industries Co Ltd come from?

All FDA import refusal data for Dong Nam Industries 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.