ORION CORP.
⚠️ Moderate Risk
FEI: 3004348360 • Pusan, PUSAN • SOUTH KOREA
FEI Number
3004348360
Location
Pusan, PUSAN
Country
SOUTH KOREAAddress
Amnamdong, , Pusan, 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
UNSAFE COL
The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).
COLOR LBLG
The article appears to contain an artificial coloring and it fails to bear labeling stating that fact.
YELLOW #5
The food appears to bear or contain the color additive FD & C Yellow No. 5, which is not declared on the label per 21 CFR 74.705(a)(c) under section 721.
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)).
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.
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.
ALLERGEN
the label fails to declare all major food allergens present in the product, as required by section 403(w)(1).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/21/2012 | 03FHT99CRACKERS (NON FILLED) N.E.C. | Los Angeles District Office (LOS-DO) | |
| 11/17/2011 | 07BGT99FRIED SNACK FOODS, N.E.C. | 324NO ENGLISH | Los Angeles District Office (LOS-DO) |
| 11/17/2011 | 07BGT06POTATO CHIPS,FRIED | 324NO ENGLISH | Los Angeles District Office (LOS-DO) |
| 6/10/2011 | 33LGT05CANDY BAR OR PIECES (NOT CARAMEL OR FONDANT), SOFT, WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE) | Los Angeles District Office (LOS-DO) | |
| 5/16/2011 | 33LGT05CANDY BAR OR PIECES (NOT CARAMEL OR FONDANT), SOFT, WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE) | Los Angeles District Office (LOS-DO) | |
| 5/16/2011 | 33LGT05CANDY BAR OR PIECES (NOT CARAMEL OR FONDANT), SOFT, WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE) | Los Angeles District Office (LOS-DO) | |
| 5/16/2011 | 33LGT05CANDY BAR OR PIECES (NOT CARAMEL OR FONDANT), SOFT, WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE) | Los Angeles District Office (LOS-DO) | |
| 1/9/2009 | 03FGY02FLAVORED OR PARTY CRACKERS | 218LIST INGRE | Los Angeles District Office (LOS-DO) |
| 12/10/2007 | 33EGY06FLAVORED CANDY, HARD (LIVE SAVERS, ETC.), WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE) | 482NUTRIT LBL | Los Angeles District Office (LOS-DO) |
| 8/30/2006 | 33EGY06FLAVORED CANDY, HARD (LIVE SAVERS, ETC.), WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE) | Los Angeles District Office (LOS-DO) | |
| 7/26/2006 | 21UET99SUBTROPICAL AND TROPICAL FRUIT, JAM, JELLY, PRESERVES, MARMALADE, BUTTER OR CANDIED, N.E.C. | 324NO ENGLISH | Seattle District Office (SEA-DO) |
| 1/17/2006 | 33EGY06FLAVORED CANDY, HARD (LIVE SAVERS, ETC.), WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE) | Los Angeles District Office (LOS-DO) | |
| 8/18/2005 | 03MFY99COOKIE,BISCUIT,WAFER DOUGH, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 7/22/2005 | 03FFY01CRACKER MEAL AND CRACKER CRUMBS | 321LACKS N/C | Los Angeles District Office (LOS-DO) |
| 5/25/2004 | 33JGT05CANDY BAR OR PIECES (NOT CARAMEL OR FONDANT), SOFT, WITH FRUIT (WITHOUT CHOCOLATE) | 11UNSAFE COL | Seattle District Office (SEA-DO) |
| 5/2/2003 | 33LGT99SOFT CANDY WITHOUT NUTS AND FRUIT, N.E.C. (WITHOUT CHOCOLATE) | Seattle District Office (SEA-DO) | |
| 5/2/2003 | 33EGT05CANDY BAR OR PIECES (NOT CARAMEL OR FONDANT), HARD, WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE) | 11UNSAFE COL | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is ORION CORP.'s FDA import refusal history?
ORION CORP. (FEI: 3004348360) has 17 FDA import refusal record(s) in our database, spanning from 5/2/2003 to 5/21/2012.
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. ORION CORP.'s FEI number is 3004348360.
What types of violations has ORION CORP. received?
ORION CORP. has been cited for 9 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. come from?
All FDA import refusal data for ORION CORP. 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.