EUROAPI FRANCE
⚠️ Moderate Risk
FEI: 1463 • Vertolaye, Puy de Dome • FRANCE
FEI Number
1463
Location
Vertolaye, Puy de Dome
Country
FRANCEAddress
4 Lieu Dit La Paterie, , Vertolaye, Puy de Dome, 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
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.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/21/2015 | 64LCS20DEXAMETHASONE SODIUM PHOSPHATE (GLUCOCORTICOID) | 75UNAPPROVED | Atlanta District Office (ATL-DO) |
| 8/17/2006 | 64LCS44METHYLPREDNISOLONE (GLUCOCORTICOID) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 8/9/2006 | 64LIS74TRIAMCINOLONE ACETONIDE (GLUCOCORTICOID) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 5/25/2006 | 64LCS19DEXAMETHASONE (GLUCOCORTICOID) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 5/11/2006 | 64LIZ37HYDROCORTISONE (GLUCOCORTICOID) | New Orleans District Office (NOL-DO) | |
| 6/9/2005 | 64LCS45METHYLPREDNISOLONE ACETATE (GLUCOCORTICOID) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 1/25/2005 | 64LCS50PREDNISOLONE (GLUCOCORTICOID) | 16DIRECTIONS | New York District Office (NYK-DO) |
Frequently Asked Questions
What is EUROAPI FRANCE's FDA import refusal history?
EUROAPI FRANCE (FEI: 1463) has 7 FDA import refusal record(s) in our database, spanning from 1/25/2005 to 1/21/2015.
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. EUROAPI FRANCE's FEI number is 1463.
What types of violations has EUROAPI FRANCE received?
EUROAPI FRANCE 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 EUROAPI FRANCE come from?
All FDA import refusal data for EUROAPI FRANCE 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.