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Han Zung Pharmaceutical Co.,Ltd.

⚠️ Moderate Risk

FEI: 3006505281 • Taejon • SOUTH KOREA

FEI

FEI Number

3006505281

📍

Location

Taejon

🇰🇷
🏢

Address

165-7 Sangseo-Dong Taeduk-Ku, , Taejon, , South Korea

Moderate Risk

FDA Import Risk Assessment

26.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
4
Unique Violations
1/31/2008
Latest Refusal
1/31/2008
Earliest Refusal

Score Breakdown

Violation Severity
55.0×40%
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

3081×

MFR INSAN

The article is subject to refusal of admission pursuant to section 801(a)(1) in that the article appears to have been manufactured, processed, or packed under insanitary conditions.

3201×

LACKS FIRM

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(e)(1) of the FD&C Act in that the food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor.

4731×

LABELING

The article appears in violation of FPLA because of its placement, form and/or contents statement.

4881×

HEALTH C

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling bears an unauthorized nutrient content/health claim.

Refusal History

DateProductViolationsDivision
1/31/2008
54ECL99HERBALS & BOTANICAL TEAS, N.E.C.
308MFR INSAN
320LACKS FIRM
473LABELING
488HEALTH C
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

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

Han Zung Pharmaceutical Co.,Ltd. (FEI: 3006505281) has 1 FDA import refusal record(s) in our database, spanning from 1/31/2008 to 1/31/2008.

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. Han Zung Pharmaceutical Co.,Ltd.'s FEI number is 3006505281.

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

Han Zung Pharmaceutical Co.,Ltd. has been cited for 4 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 Zung Pharmaceutical Co.,Ltd. come from?

All FDA import refusal data for Han Zung 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.