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Damin Health Care Co Ltd

⚠️ Moderate Risk

FEI: 3004639163 • Seoul • SOUTH KOREA

FEI

FEI Number

3004639163

📍

Location

Seoul

🇰🇷
🏢

Address

2614 Yongdu Dong, , Seoul, , South Korea

Moderate Risk

FDA Import Risk Assessment

40.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
9/11/2004
Latest Refusal
9/11/2004
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
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

751×

UNAPPROVED

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).

Refusal History

DateProductViolationsDivision
9/11/2004
53LD99OTHER SKIN CARE PREPARATIONS, N.E.C.
75UNAPPROVED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Damin Health Care Co Ltd's FDA import refusal history?

Damin Health Care Co Ltd (FEI: 3004639163) has 1 FDA import refusal record(s) in our database, spanning from 9/11/2004 to 9/11/2004.

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. Damin Health Care Co Ltd's FEI number is 3004639163.

What types of violations has Damin Health Care Co Ltd received?

Damin Health Care 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 Damin Health Care Co Ltd come from?

All FDA import refusal data for Damin Health Care 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.