Sellus Co., Ltd
⚠️ Moderate Risk
FEI: 3005950987 • Eumseong, Chungcheongbuk • SOUTH KOREA
FEI Number
3005950987
Location
Eumseong, Chungcheongbuk
Country
SOUTH KOREAAddress
20 Meongsimigil264beon-Gil, Geumwang-Eup, Eumseong, Chungcheongbuk, 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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/24/2007 | 41BYT99FOODS WITH SUPPLEMENTAL NUTRIENTS ADDED, WITH OR WITHOUT ARTIFICAL SWEETNERS | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 9/24/2007 | 41BYT99FOODS WITH SUPPLEMENTAL NUTRIENTS ADDED, WITH OR WITHOUT ARTIFICAL SWEETNERS | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 9/24/2007 | 41BYT99FOODS WITH SUPPLEMENTAL NUTRIENTS ADDED, WITH OR WITHOUT ARTIFICAL SWEETNERS | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 9/24/2007 | 41BYT99FOODS WITH SUPPLEMENTAL NUTRIENTS ADDED, WITH OR WITHOUT ARTIFICAL SWEETNERS | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 9/24/2007 | 41BYT99FOODS WITH SUPPLEMENTAL NUTRIENTS ADDED, WITH OR WITHOUT ARTIFICAL SWEETNERS | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 9/24/2007 | 41BYT99FOODS WITH SUPPLEMENTAL NUTRIENTS ADDED, WITH OR WITHOUT ARTIFICAL SWEETNERS | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Sellus Co., Ltd's FDA import refusal history?
Sellus Co., Ltd (FEI: 3005950987) has 6 FDA import refusal record(s) in our database, spanning from 9/24/2007 to 9/24/2007.
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. Sellus Co., Ltd's FEI number is 3005950987.
What types of violations has Sellus Co., Ltd received?
Sellus Co., Ltd has been cited for 1 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 Sellus Co., Ltd come from?
All FDA import refusal data for Sellus Co., Ltd 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.