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SAMSUNG BIOEPIS GLOBAL CENTER

⚠️ Moderate Risk

FEI: 3026998525 • Yeonsu, Incheon • SOUTH KOREA

FEI

FEI Number

3026998525

📍

Location

Yeonsu, Incheon

🇰🇷
🏢

Address

300 Songdobaiodae-Ro, , Yeonsu, Incheon, South Korea

Moderate Risk

FDA Import Risk Assessment

43.5
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
11/4/2025
Latest Refusal
11/4/2025
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
11.2×30%
Recency
95.8×20%
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

32801×

FRNMFGREG

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.

Refusal History

DateProductViolationsDivision
11/4/2025
58SCP01ADALIMUMAB-BWWD
3280FRNMFGREG
Division of West Coast Imports (DWCI)

Frequently Asked Questions

What is SAMSUNG BIOEPIS GLOBAL CENTER's FDA import refusal history?

SAMSUNG BIOEPIS GLOBAL CENTER (FEI: 3026998525) has 1 FDA import refusal record(s) in our database, spanning from 11/4/2025 to 11/4/2025.

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. SAMSUNG BIOEPIS GLOBAL CENTER's FEI number is 3026998525.

What types of violations has SAMSUNG BIOEPIS GLOBAL CENTER received?

SAMSUNG BIOEPIS GLOBAL CENTER 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 SAMSUNG BIOEPIS GLOBAL CENTER come from?

All FDA import refusal data for SAMSUNG BIOEPIS GLOBAL CENTER 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.