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Celltrion Skincure Co., Ltd. (Hanskin)

✅ Low Risk

FEI: 3008327789 • Paju, Gyeonggi • SOUTH KOREA

FEI

FEI Number

3008327789

📍

Location

Paju, Gyeonggi

🇰🇷
🏢

Address

Hanskin Distribution Center, 35 Sinchon2-Ro, Paju, Gyeonggi, South Korea

Low Risk

FDA Import Risk Assessment

24.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
9/24/2012
Latest Refusal
9/24/2012
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
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).

Refusal History

DateProductViolationsDivision
9/24/2012
53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
118NOT LISTED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Celltrion Skincure Co., Ltd. (Hanskin)'s FDA import refusal history?

Celltrion Skincure Co., Ltd. (Hanskin) (FEI: 3008327789) has 1 FDA import refusal record(s) in our database, spanning from 9/24/2012 to 9/24/2012.

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. Celltrion Skincure Co., Ltd. (Hanskin)'s FEI number is 3008327789.

What types of violations has Celltrion Skincure Co., Ltd. (Hanskin) received?

Celltrion Skincure Co., Ltd. (Hanskin) 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 Celltrion Skincure Co., Ltd. (Hanskin) come from?

All FDA import refusal data for Celltrion Skincure Co., Ltd. (Hanskin) 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.