Korea Ginseng Bio-Science Co., Ltd.
⚠️ Moderate Risk
FEI: 3004106080 • Paju, Gyeonggi • SOUTH KOREA
FEI Number
3004106080
Location
Paju, Gyeonggi
Country
SOUTH KOREAAddress
1145 Surihol-Lo, Beobwon-Eup, Paju, Gyeonggi, 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 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.
NEEDS FCE
It appears the manufacturer is not registered as a low acid canned food or acidified food manufacturer pursuant to 21 CFR 108.25(c)(1) or 108.35(c)(1).
LACKS N/C
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)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count in accordance with Section 403(e)(2) of the FD&C Act.
UNDER PRC
The article appears to have inadequate processing in having been prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health.
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.
NUTRIT LBL
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 fails to bear the required nutrition information.
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.
LIST INGRE
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)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/12/2012 | 31KGE99TEA, N.E.C. | 181UNDER PRC | New York District Office (NYK-DO) |
| 1/12/2012 | 31KGE99TEA, N.E.C. | 181UNDER PRC | New York District Office (NYK-DO) |
| 6/13/2007 | 54FCY99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 83NO PROCESS | San Francisco District Office (SAN-DO) |
| 6/13/2007 | 54FCY99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 83NO PROCESS | San Francisco District Office (SAN-DO) |
| 5/30/2007 | 54FDF12GINSENG (HERBAL & BOTANICALS, NOT TEAS) | 62NEEDS FCE | Los Angeles District Office (LOS-DO) |
| 5/9/2006 | 30YYE99BEVERAGE BASE NOT MENTIONED ELSEWHERE, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 5/9/2006 | 30YYE99BEVERAGE BASE NOT MENTIONED ELSEWHERE, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 1/26/2005 | 25GDN99MIXED VEGETABLES, JUICE OR DRINK, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 1/20/2005 | 25MYD99ROOT & TUBER VEGETABLE, JUICE OR DRINK, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 1/20/2005 | 25MDT99ROOT & TUBER VEGETABLE, JUICE OR DRINK, N.E.C. | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Korea Ginseng Bio-Science Co., Ltd.'s FDA import refusal history?
Korea Ginseng Bio-Science Co., Ltd. (FEI: 3004106080) has 10 FDA import refusal record(s) in our database, spanning from 1/20/2005 to 1/12/2012.
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 Ginseng Bio-Science Co., Ltd.'s FEI number is 3004106080.
What types of violations has Korea Ginseng Bio-Science Co., Ltd. received?
Korea Ginseng Bio-Science Co., Ltd. has been cited for 8 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 Ginseng Bio-Science Co., Ltd. come from?
All FDA import refusal data for Korea Ginseng Bio-Science 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.