Conseil De L'Europe
⚠️ Moderate Risk
FEI: 3006400391 • Strasbourg • FRANCE
FEI Number
3006400391
Location
Strasbourg
Country
FRANCEAddress
7 Alle Kasiner, , Strasbourg, , 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.
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/3/2014 | 60QAY28THIOPENTAL SODIUM (ANESTHETIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 8/22/2014 | 60QAY28THIOPENTAL SODIUM (ANESTHETIC) | 16DIRECTIONS | Cincinnati District Office (CIN-DO) |
| 11/3/2011 | 81NPRTEST, FACTOR II G20210A MUTATIONS, GENOMIC DNA PCR | Florida District Office (FLA-DO) | |
| 8/12/2008 | 66VIS99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Conseil De L'Europe's FDA import refusal history?
Conseil De L'Europe (FEI: 3006400391) has 4 FDA import refusal record(s) in our database, spanning from 8/12/2008 to 10/3/2014.
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 3006400391.
What types of violations has Conseil De L'Europe received?
Conseil De L'Europe 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 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.