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Changjo Int'L Ltd

⚠️ Moderate Risk

FEI: 3001419610 • Inchon • SOUTH KOREA

FEI

FEI Number

3001419610

📍

Location

Inchon

🇰🇷
🏢

Address

435-6 Nandong-Gondan 45b/6f, , Inchon, , South Korea

Moderate Risk

FDA Import Risk Assessment

30.0
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
9/20/2007
Latest Refusal
9/20/2007
Earliest Refusal

Score Breakdown

Violation Severity
56.7×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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

5082×

NO 510(K)

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.

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
9/20/2007
84NUHSTIMULATOR, NERVE, TRANSCUTANEOUS, OVER-THE-COUNTER
508NO 510(K)
Los Angeles District Office (LOS-DO)
9/20/2007
84NUHSTIMULATOR, NERVE, TRANSCUTANEOUS, OVER-THE-COUNTER
341REGISTERED
508NO 510(K)
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Changjo Int'L Ltd's FDA import refusal history?

Changjo Int'L Ltd (FEI: 3001419610) has 2 FDA import refusal record(s) in our database, spanning from 9/20/2007 to 9/20/2007.

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. Changjo Int'L Ltd's FEI number is 3001419610.

What types of violations has Changjo Int'L Ltd received?

Changjo Int'L 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 Changjo Int'L Ltd come from?

All FDA import refusal data for Changjo Int'L 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.