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Han Kook Shin Yak Pharmaceutical Co., Ltd.

⚠️ Moderate Risk

FEI: 3010165801 • Nonsan, Chungnam • SOUTH KOREA

FEI

FEI Number

3010165801

📍

Location

Nonsan, Chungnam

🇰🇷
🏢

Address

39-83 Jungsan-Gil, Yangchon-Myeon, Nonsan, Chungnam, 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
12/21/2005
Latest Refusal
12/21/2005
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
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

21201×

UNSFDIETSP

The article appears to be a dietary supplement or ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury.

Refusal History

DateProductViolationsDivision
12/21/2005
66VBR99MISCELLANEOUS PATENT MEDICINES, ETC.
2120UNSFDIETSP
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Han Kook Shin Yak Pharmaceutical Co., Ltd.'s FDA import refusal history?

Han Kook Shin Yak Pharmaceutical Co., Ltd. (FEI: 3010165801) has 1 FDA import refusal record(s) in our database, spanning from 12/21/2005 to 12/21/2005.

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. Han Kook Shin Yak Pharmaceutical Co., Ltd.'s FEI number is 3010165801.

What types of violations has Han Kook Shin Yak Pharmaceutical Co., Ltd. received?

Han Kook Shin Yak Pharmaceutical 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 Han Kook Shin Yak Pharmaceutical Co., Ltd. come from?

All FDA import refusal data for Han Kook Shin Yak Pharmaceutical 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.