SONGHWASU KOREAN RED GINSENG
⚠️ Moderate Risk
FEI: 3013030844 • Jinan-gun, Jeonrabug-do • SOUTH KOREA
FEI Number
3013030844
Location
Jinan-gun, Jeonrabug-do
Country
SOUTH KOREAAddress
1964 Jeonjin-ro, Bugwi-myeon, Jinan-gun, Jeonrabug-do, South Korea
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
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
NO ENGLISH
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(f) of the FD&C Act in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use (for example, label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1), except in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English)).
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/30/2021 | 54FBR12GINSENG (HERBAL & BOTANICALS, NOT TEAS) | 324NO ENGLISH | Division of Southeast Imports (DSEI) |
| 3/30/2021 | 54FBR12GINSENG (HERBAL & BOTANICALS, NOT TEAS) | 324NO ENGLISH | Division of Southeast Imports (DSEI) |
| 11/20/2018 | 54EBL12GINSENG (HERBAL & BOTANICAL TEAS) | 83NO PROCESS | Division of West Coast Imports (DWCI) |
| 11/20/2018 | 54EBL12GINSENG (HERBAL & BOTANICAL TEAS) | 83NO PROCESS | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is SONGHWASU KOREAN RED GINSENG's FDA import refusal history?
SONGHWASU KOREAN RED GINSENG (FEI: 3013030844) has 4 FDA import refusal record(s) in our database, spanning from 11/20/2018 to 3/30/2021.
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. SONGHWASU KOREAN RED GINSENG's FEI number is 3013030844.
What types of violations has SONGHWASU KOREAN RED GINSENG received?
SONGHWASU KOREAN RED GINSENG 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 SONGHWASU KOREAN RED GINSENG come from?
All FDA import refusal data for SONGHWASU KOREAN RED GINSENG 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.