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ORION CORP.

⚠️ Moderate Risk

FEI: 3004348360 • Pusan, PUSAN • SOUTH KOREA

FEI

FEI Number

3004348360

📍

Location

Pusan, PUSAN

🇰🇷
🏢

Address

Amnamdong, , Pusan, PUSAN, South Korea

Moderate Risk

FDA Import Risk Assessment

37.2
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

17
Total Refusals
9
Unique Violations
5/21/2012
Latest Refusal
5/2/2003
Earliest Refusal

Score Breakdown

Violation Severity
53.3×40%
Refusal Volume
46.5×30%
Recency
0.0×20%
Frequency
18.8×10%
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

118×

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).

2747×

COLOR LBLG

The article appears to contain an artificial coloring and it fails to bear labeling stating that fact.

646×

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.

3245×

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)).

2184×

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.

3213×

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.

3201×

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.

33001×

ALLERGEN

the label fails to declare all major food allergens present in the product, as required by section 403(w)(1).

4821×

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

DateProductViolationsDivision
5/21/2012
03FHT99CRACKERS (NON FILLED) N.E.C.
218LIST INGRE
3300ALLERGEN
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)
11UNSAFE COL
274COLOR LBLG
324NO ENGLISH
64YELLOW #5
Los Angeles District Office (LOS-DO)
5/16/2011
33LGT05CANDY BAR OR PIECES (NOT CARAMEL OR FONDANT), SOFT, WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE)
11UNSAFE COL
274COLOR LBLG
64YELLOW #5
Los Angeles District Office (LOS-DO)
5/16/2011
33LGT05CANDY BAR OR PIECES (NOT CARAMEL OR FONDANT), SOFT, WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE)
11UNSAFE COL
274COLOR LBLG
64YELLOW #5
Los Angeles District Office (LOS-DO)
5/16/2011
33LGT05CANDY BAR OR PIECES (NOT CARAMEL OR FONDANT), SOFT, WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE)
11UNSAFE COL
274COLOR LBLG
64YELLOW #5
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)
218LIST INGRE
274COLOR LBLG
64YELLOW #5
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)
11UNSAFE COL
274COLOR LBLG
320LACKS FIRM
321LACKS N/C
324NO ENGLISH
Los Angeles District Office (LOS-DO)
8/18/2005
03MFY99COOKIE,BISCUIT,WAFER DOUGH, N.E.C.
218LIST INGRE
321LACKS N/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)
11UNSAFE COL
274COLOR LBLG
64YELLOW #5
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.