Conseil De L'Europe
⚠️ Moderate Risk
FEI: 3003081334 • Strasbourg, Bas Rhin • FRANCE
FEI Number
3003081334
Location
Strasbourg, Bas Rhin
Country
FRANCEAddress
224 avenue de Colmar, , Strasbourg, Bas Rhin, France
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
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/19/2006 | 61JCR09FENOFIBRATE (ANTI-CHOLESTEREMIC) | New York District Office (NYK-DO) | |
| 1/5/2006 | 62KAA08LOPERAMIDE HYDROCHLORIDE (ANTI-PERISTALTIC, ANTI-DIARRHEAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/9/2004 | 60LAS01ACETAMINOPHEN (ANALGESIC) | New York District Office (NYK-DO) | |
| 4/12/2004 | 66MIY98HALOPERIDOL DECANOATE (TRANQUILIZER, ANTI-PSYCHOTIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/12/2004 | 60LIY69TRAMADOL HCL (ANALGESIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Conseil De L'Europe's FDA import refusal history?
Conseil De L'Europe (FEI: 3003081334) has 5 FDA import refusal record(s) in our database, spanning from 4/12/2004 to 1/19/2006.
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. Conseil De L'Europe's FEI number is 3003081334.
What types of violations has Conseil De L'Europe received?
Conseil De L'Europe has been cited for 3 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 Conseil De L'Europe come from?
All FDA import refusal data for Conseil De L'Europe 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.