Orion Corporation, Orion Pharma
⚠️ High Risk
FEI: 3003073605 • Espoo, Helsinki-Uusimaa • FINLAND
FEI Number
3003073605
Location
Espoo, Helsinki-Uusimaa
Country
FINLANDAddress
Orionintie 1, , Espoo, Helsinki-Uusimaa, Finland
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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
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).
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).
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.
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/22/2025 | 66JCA01LEVOTHYROXINE SODIUM (THYROID HORMONE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/16/2024 | 66MDA03ALPRAZOLAM (TRANQUILIZER) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/22/2019 | 64LCA44METHYLPREDNISOLONE (GLUCOCORTICOID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/24/2016 | 66YCY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 11/24/2014 | 66YCY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 3/9/2009 | 83JSJCULTURE MEDIA, SELECTIVE AND NON-DIFFERENTIAL | 341REGISTERED | Cincinnati District Office (CIN-DO) |
| 6/30/2006 | 61WBS31TOLNAFTATE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | New York District Office (NYK-DO) | |
| 4/28/2004 | 60TCY99ANTAGONIST, N.E.C. | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Orion Corporation, Orion Pharma's FDA import refusal history?
Orion Corporation, Orion Pharma (FEI: 3003073605) has 8 FDA import refusal record(s) in our database, spanning from 4/28/2004 to 8/22/2025.
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, Orion Pharma's FEI number is 3003073605.
What types of violations has Orion Corporation, Orion Pharma received?
Orion Corporation, Orion Pharma has been cited for 4 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, Orion Pharma come from?
All FDA import refusal data for Orion Corporation, Orion Pharma 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.