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Insung Pharmaceutical Co.,Ltd

⚠️ Moderate Risk

FEI: 3004695642 • Umsung-gun, KR-43 • SOUTH KOREA

FEI

FEI Number

3004695642

📍

Location

Umsung-gun, KR-43

🇰🇷
🏢

Address

9-5 Buyun-Ri, Daeso-Myun, Umsung-Gun, , Umsung-gun, KR-43, South Korea

Moderate Risk

FDA Import Risk Assessment

28.6
LowModerateHighCritical

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

Statistics

2
Total Refusals
3
Unique Violations
10/31/2008
Latest Refusal
10/31/2008
Earliest Refusal

Score Breakdown

Violation Severity
53.3×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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

22002×

DIET INGRE

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be for use as an ingredient in a dietary supplement and appears to be or may be otherwise unfit for food.

23002×

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.

3282×

USUAL NAME

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(1) of the FD&C Act in that the label fails to bear the common or usual name of the food, if any there be.

Refusal History

DateProductViolationsDivision
10/31/2008
54YCA99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
2200DIET INGRE
2300DIETARYLBL
328USUAL NAME
Los Angeles District Office (LOS-DO)
10/31/2008
54YCA99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
2200DIET INGRE
2300DIETARYLBL
328USUAL NAME
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Insung Pharmaceutical Co.,Ltd's FDA import refusal history?

Insung Pharmaceutical Co.,Ltd (FEI: 3004695642) has 2 FDA import refusal record(s) in our database, spanning from 10/31/2008 to 10/31/2008.

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. Insung Pharmaceutical Co.,Ltd's FEI number is 3004695642.

What types of violations has Insung Pharmaceutical Co.,Ltd received?

Insung Pharmaceutical Co.,Ltd has been cited for 3 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 Insung Pharmaceutical Co.,Ltd come from?

All FDA import refusal data for Insung 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.