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DONG PHARMACEUTICAL

⚠️ Moderate Risk

FEI: 3012320490 • SEOUL • SOUTH KOREA

FEI

FEI Number

3012320490

📍

Location

SEOUL

🇰🇷
🏢

Address

252 YOUNGDU-DONG, , SEOUL, , South Korea

Moderate Risk

FDA Import Risk Assessment

36.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
1/6/2025
Latest Refusal
1/6/2025
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
Refusal Volume
11.2×30%
Recency
79.8×20%
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

23001×

DIETARYLBL

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(s)(2)(B) of the FD&C Act in that the label or labeling fails to identify the product by using the term "dietary supplement", which term may be modified with the name of such an ingredient.

Refusal History

DateProductViolationsDivision
1/6/2025
29BCT99CARBONATED SOFT DRINK, N.E.C.
2300DIETARYLBL
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is DONG PHARMACEUTICAL's FDA import refusal history?

DONG PHARMACEUTICAL (FEI: 3012320490) has 1 FDA import refusal record(s) in our database, spanning from 1/6/2025 to 1/6/2025.

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. DONG PHARMACEUTICAL's FEI number is 3012320490.

What types of violations has DONG PHARMACEUTICAL received?

DONG PHARMACEUTICAL 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 DONG PHARMACEUTICAL come from?

All FDA import refusal data for DONG PHARMACEUTICAL 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.