Sanofi Aventis
⚠️ High Risk
FEI: 3008918733 • Megrine, Ben Arous • TUNISIA
FEI Number
3008918733
Location
Megrine, Ben Arous
Country
TUNISIAAddress
34 Avenue De Paris, , Megrine, Ben Arous, Tunisia
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/19/2025 | 62LDY36QUININE DIHYDROCHLORIDE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/19/2025 | 66YDY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/19/2025 | 66YDY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/31/2023 | 61MDY30VALPROATE SODIUM (ANTI-CONVULSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/5/2012 | 62ODB05RAMIPRIL (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Sanofi Aventis's FDA import refusal history?
Sanofi Aventis (FEI: 3008918733) has 5 FDA import refusal record(s) in our database, spanning from 4/5/2012 to 3/19/2025.
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. Sanofi Aventis's FEI number is 3008918733.
What types of violations has Sanofi Aventis received?
Sanofi Aventis has been cited for 1 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 Sanofi Aventis come from?
All FDA import refusal data for Sanofi Aventis 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.