ORION CORPORATION
⚠️ Moderate Risk
FEI: 3005490741 • Seoul, Seoul Teugbyeolsi • SOUTH KOREA
FEI Number
3005490741
Location
Seoul, Seoul Teugbyeolsi
Country
SOUTH KOREAAddress
Seoul, 140715 Korea, 13 90 da-Gil, Baekbum-Ro, Yongsan-gu, Seoul, Seoul Teugbyeolsi, 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 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)).
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.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/21/2018 | 03AFT03BISCUITS | Division of Southeast Imports (DSEI) | |
| 8/21/2018 | 03AFT03BISCUITS | Division of Southeast Imports (DSEI) | |
| 8/21/2018 | 35AGT04GRASS JELLY (GELATIN PRODUCT) | Division of Southeast Imports (DSEI) | |
| 5/24/2018 | 03AFT03BISCUITS | 324NO ENGLISH | Division of Southeast Imports (DSEI) |
| 5/24/2018 | 03AFT03BISCUITS | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is ORION CORPORATION's FDA import refusal history?
ORION CORPORATION (FEI: 3005490741) has 5 FDA import refusal record(s) in our database, spanning from 5/24/2018 to 8/21/2018.
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 CORPORATION's FEI number is 3005490741.
What types of violations has ORION CORPORATION received?
ORION CORPORATION has been cited for 3 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 CORPORATION come from?
All FDA import refusal data for ORION CORPORATION 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.