Ionfarms Co., Ltd.
⚠️ Moderate Risk
FEI: 3005155687 • Incheon • 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
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/16/2008 | 80LDQDEVICE, GENERAL MEDICAL | 223FALSE | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Ionfarms Co., Ltd.'s FDA import refusal history?
Ionfarms Co., Ltd. (FEI: 3005155687) has 1 FDA import refusal record(s) in our database, spanning from 6/16/2008 to 6/16/2008.
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. Ionfarms Co., Ltd.'s FEI number is 3005155687.
What types of violations has Ionfarms Co., Ltd. received?
Ionfarms 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 Ionfarms Co., Ltd. come from?
All FDA import refusal data for Ionfarms 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.