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Korea - Redginseng Products

⚠️ Moderate Risk

FEI: 3008605051 • Gyeonggi-do • SOUTH KOREA

FEI

FEI Number

3008605051

📍

Location

Gyeonggi-do

🇰🇷
🏢

Address

76-18, Goryeo Health, Deukyang, , Gyeonggi-do, , South Korea

Moderate Risk

FDA Import Risk Assessment

33.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
1/18/2011
Latest Refusal
1/18/2011
Earliest Refusal

Score Breakdown

Violation Severity
65.0×40%
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

2601×

FALSE

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(a)(1 ) of the FD&C Act in that the labeling is false or misleading in any particular.

831×

NO PROCESS

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the manufacturer's failure to file a scheduled process demonstrates that the product is not being manufactured under the mandatory provisions of 21 CFR Part 108 and therefore appears to have been manufactured, processed, or packed, under insanitary conditions whereby it may have been rendered injurious to health.

Refusal History

DateProductViolationsDivision
1/18/2011
54FCY12GINSENG (HERBAL & BOTANICALS, NOT TEAS)
83NO PROCESS
Los Angeles District Office (LOS-DO)
1/18/2011
54FCY12GINSENG (HERBAL & BOTANICALS, NOT TEAS)
260FALSE
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Korea - Redginseng Products's FDA import refusal history?

Korea - Redginseng Products (FEI: 3008605051) has 2 FDA import refusal record(s) in our database, spanning from 1/18/2011 to 1/18/2011.

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. Korea - Redginseng Products's FEI number is 3008605051.

What types of violations has Korea - Redginseng Products received?

Korea - Redginseng Products 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 Korea - Redginseng Products come from?

All FDA import refusal data for Korea - Redginseng Products 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.