Fermion Oy
⚠️ Moderate Risk
FEI: 3002807817 • Hanko Pohjoinen, Uusimaa • FINLAND
FEI Number
3002807817
Location
Hanko Pohjoinen, Uusimaa
Country
FINLANDAddress
Orioninkatu 2, , Hanko Pohjoinen, 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.
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/9/2005 | 61PCS09GLIPIZIDE (ANTI-DIABETIC) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 5/18/2005 | 64TCS08TACROLIMUS (IMMUNOSUPPRESSIVE) | New York District Office (NYK-DO) | |
| 7/15/2003 | 62OCS24DILTIAZEM HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II) | 16DIRECTIONS | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Fermion Oy's FDA import refusal history?
Fermion Oy (FEI: 3002807817) has 3 FDA import refusal record(s) in our database, spanning from 7/15/2003 to 6/9/2005.
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 3002807817.
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.