Fermion Oy
⚠️ Moderate Risk
FEI: 3003491490 • Espoo, Helsinki-Uusimaa • FINLAND
FEI Number
3003491490
Location
Espoo, Helsinki-Uusimaa
Country
FINLANDAddress
Koivu-Mankkaan Tie 6, , Espoo, Helsinki-Uusimaa, Finland
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
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/28/2017 | 60YIS99INHIBITOR (GROWTH FACTOR) N.E.C. | 16DIRECTIONS | Division of Northeast Imports (DNEI) |
| 3/21/2014 | 62IAY31METHOTREXATE (ANTI-NEOPLASTIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/2/2007 | 66MCS03ALPRAZOLAM (TRANQUILIZER) | 16DIRECTIONS | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Fermion Oy's FDA import refusal history?
Fermion Oy (FEI: 3003491490) has 3 FDA import refusal record(s) in our database, spanning from 8/2/2007 to 9/28/2017.
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. Fermion Oy's FEI number is 3003491490.
What types of violations has Fermion Oy received?
Fermion Oy has been cited for 2 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 Fermion Oy come from?
All FDA import refusal data for Fermion Oy 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.