European Dictorate For The Quality Of Medicines
⚠️ Moderate Risk
FEI: 3005729756 • Cedex • 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
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
Frequently Asked Questions
What is European Dictorate For The Quality Of Medicines's FDA import refusal history?
European Dictorate For The Quality Of Medicines (FEI: 3005729756) has 1 FDA import refusal record(s) in our database, spanning from 11/3/2006 to 11/3/2006.
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. European Dictorate For The Quality Of Medicines's FEI number is 3005729756.
What types of violations has European Dictorate For The Quality Of Medicines received?
European Dictorate For The Quality Of Medicines 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 European Dictorate For The Quality Of Medicines come from?
All FDA import refusal data for European Dictorate For The Quality Of Medicines 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.