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Won Herb Medicine Pharmaceutical

✅ Low Risk

FEI: 3005780071 • Kimjae • SOUTH KOREA

FEI

FEI Number

3005780071

📍

Location

Kimjae

🇰🇷
🏢

Address

955-2 Sun Dong, , Kimjae, , South Korea

Low Risk

FDA Import Risk Assessment

18.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
2
Unique Violations
3/22/2007
Latest Refusal
3/22/2007
Earliest Refusal

Score Breakdown

Violation Severity
35.0×40%
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

3351×

LACKS N/C

The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.

4721×

NO ENGLISH

Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).

Refusal History

DateProductViolationsDivision
3/22/2007
66VBL99MISCELLANEOUS PATENT MEDICINES, ETC.
335LACKS N/C
472NO ENGLISH
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Won Herb Medicine Pharmaceutical's FDA import refusal history?

Won Herb Medicine Pharmaceutical (FEI: 3005780071) has 1 FDA import refusal record(s) in our database, spanning from 3/22/2007 to 3/22/2007.

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. Won Herb Medicine Pharmaceutical's FEI number is 3005780071.

What types of violations has Won Herb Medicine Pharmaceutical received?

Won Herb Medicine Pharmaceutical has been cited for 2 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 Won Herb Medicine Pharmaceutical come from?

All FDA import refusal data for Won Herb Medicine 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.