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DongKoo Pharm Ind. Co., Ltd.

⚠️ Moderate Risk

FEI: 3004650391 • Hwasung-Si, Gyeonggido • SOUTH KOREA

FEI

FEI Number

3004650391

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Location

Hwasung-Si, Gyeonggido

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Address

901-3 Sangsin-Ri, Hyangnam-Eup, , Hwasung-Si, Gyeonggido, South Korea

Moderate Risk

FDA Import Risk Assessment

32.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
9/22/2015
Latest Refusal
9/22/2015
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
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

1151×

DR QUALITY

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to be represented as a drug the name of which is recognized in an official compendium and its strength appears to differ from or its quality or purity appear to fall below the standards set forth in such compendium.

Refusal History

DateProductViolationsDivision
9/22/2015
60LBH01ACETAMINOPHEN (ANALGESIC)
115DR QUALITY
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is DongKoo Pharm Ind. Co., Ltd.'s FDA import refusal history?

DongKoo Pharm Ind. Co., Ltd. (FEI: 3004650391) has 1 FDA import refusal record(s) in our database, spanning from 9/22/2015 to 9/22/2015.

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. DongKoo Pharm Ind. Co., Ltd.'s FEI number is 3004650391.

What types of violations has DongKoo Pharm Ind. Co., Ltd. received?

DongKoo Pharm Ind. 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 DongKoo Pharm Ind. Co., Ltd. come from?

All FDA import refusal data for DongKoo Pharm Ind. 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.