Sanofi Aventis
⚠️ High Risk
FEI: 3009457349 • Paris, Paris • FRANCE
FEI Number
3009457349
Location
Paris, Paris
Country
FRANCEAddress
54 rue la Boetie, , Paris, Paris, France
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).
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/7/2025 | 60ODE05TEGASEROD MALEATE (AGONIST) | Division of West Coast Imports (DWCI) | |
| 4/2/2020 | 64BDY25HYDROCHLOROTHIAZIDE (DIURETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/25/2017 | 61LDY29ENOXAPARIN SODIUM (ANTI-COAGULANT) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 2/1/2017 | 61PCY99ANTI-DIABETIC N.E.C. | Cincinnati District Office (CIN-DO) | |
| 2/1/2017 | 61PCY99ANTI-DIABETIC N.E.C. | Cincinnati District Office (CIN-DO) | |
| 12/17/2015 | 64BDY37SPIRONOLACTONE (DIURETIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 12/17/2015 | 63EDY19AMIODARONE HYDROCHLORIDE (CARDIAC DEPRESSANT (ANTI-ARRHYTHMIC)) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 12/26/2013 | 61LDB38CLOPIDOGREL BISULFATE (ANTI-COAGULANT) | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
Frequently Asked Questions
What is Sanofi Aventis's FDA import refusal history?
Sanofi Aventis (FEI: 3009457349) has 8 FDA import refusal record(s) in our database, spanning from 12/26/2013 to 5/7/2025.
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 3009457349.
What types of violations has Sanofi Aventis received?
Sanofi Aventis 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 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.