KNF Korea Inc
⚠️ Moderate Risk
FEI: 3008929146 • Geumjeong-Gu, PUSAN • SOUTH KOREA
FEI Number
3008929146
Location
Geumjeong-Gu, PUSAN
Country
SOUTH KOREAAddress
44-1 Geumsa-Dong, , Geumjeong-Gu, PUSAN, 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).
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.
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.
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/23/2013 | 54ECT92CODONOPSIS TANSHEN (HERBAL & BOTANICAL TEAS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 2/12/2013 | 25MVE21GARLIC BULB, JUICE OR DRINK | Los Angeles District Office (LOS-DO) | |
| 2/12/2013 | 20DYN02BLUEBERRY JUICE, BERRY JUICE OR CONCENTRATES | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 11/1/2012 | 31MVI02TEA WITH EXTRACTS OR CONCENTRATES | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 11/1/2012 | 31MVI02TEA WITH EXTRACTS OR CONCENTRATES | 62NEEDS FCE | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is KNF Korea Inc's FDA import refusal history?
KNF Korea Inc (FEI: 3008929146) has 5 FDA import refusal record(s) in our database, spanning from 11/1/2012 to 12/23/2013.
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. KNF Korea Inc's FEI number is 3008929146.
What types of violations has KNF Korea Inc received?
KNF Korea Inc has been cited for 5 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 KNF Korea Inc come from?
All FDA import refusal data for KNF Korea Inc 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.