ORION Corp. Iksan Plant(2)
⚠️ Moderate Risk
FEI: 3004293179 • Iksan, Jeollabuk • SOUTH KOREA
FEI Number
3004293179
Location
Iksan, Jeollabuk
Country
SOUTH KOREAAddress
813-2 Shinhungng, , Iksan, Jeollabuk, 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
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.
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.
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.
ALLERGEN
the label fails to declare all major food allergens present in the product, as required by section 403(w)(1).
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.
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)).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/19/2019 | 33LGT07JELLIED CANDY, SOFT (JELLY BEANS, GUM DROPS, ETC.), WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE) | Division of West Coast Imports (DWCI) | |
| 1/19/2017 | 33LGT07JELLIED CANDY, SOFT (JELLY BEANS, GUM DROPS, ETC.), WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE) | 218LIST INGRE | Seattle District Office (SEA-DO) |
| 9/1/2015 | 07BGT99FRIED SNACK FOODS, N.E.C. | Seattle District Office (SEA-DO) | |
| 8/12/2005 | 03JGT02CHOCOLATE FILLED/ICED COOKIES,BISCUITS AND WAFERS | Los Angeles District Office (LOS-DO) | |
| 8/12/2005 | 03HGT99PLAIN COOKIES,BISCUITS AND WAFERS, N.E.C. | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is ORION Corp. Iksan Plant(2)'s FDA import refusal history?
ORION Corp. Iksan Plant(2) (FEI: 3004293179) has 5 FDA import refusal record(s) in our database, spanning from 8/12/2005 to 12/19/2019.
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. ORION Corp. Iksan Plant(2)'s FEI number is 3004293179.
What types of violations has ORION Corp. Iksan Plant(2) received?
ORION Corp. Iksan Plant(2) has been cited for 6 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 ORION Corp. Iksan Plant(2) come from?
All FDA import refusal data for ORION Corp. Iksan Plant(2) 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.