Sanofi Aventis France
⚠️ Moderate Risk
FEI: 3008575899 • Paris, Paris • FRANCE
FEI Number
3008575899
Location
Paris, Paris
Country
FRANCEAddress
1 boulevard Romain Rolland, , Paris, Paris, 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).
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.
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).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
RX LEGEND
The article appears to be a prescription drug without a prescription drug legend as required by Section 503(b)(4).
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.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/26/2019 | 62GLM46KETOPROFEN (ANTI-INFLAMMATORY) | Division of Northeast Imports (DNEI) | |
| 1/31/2018 | 62KAY08LOPERAMIDE HYDROCHLORIDE (ANTI-PERISTALTIC, ANTI-DIARRHEAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/21/2016 | 66VDA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/3/2016 | 61NCC55SULPIRIDE (ANTI-DEPRESSANT) | 16DIRECTIONS | Philadelphia District Office (PHI-DO) |
| 8/24/2016 | 61MCB35DIVALPROEX SODIUM (ANTI-CONVULSANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/25/2016 | 61PCL17INSULIN (INJ) (ANTI-DIABETIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/25/2016 | 64OCA05SILTUXIMAB, MONOCLONAL ANTIBODIES | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 9/21/2012 | 66VAA99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 6/19/2012 | 61NCB99ANTI-DEPRESSANT N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/27/2012 | 56CCA64CEFPODOXIME PROXETIL (CEPHALOSPORINS) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 7/29/2009 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Sanofi Aventis France's FDA import refusal history?
Sanofi Aventis France (FEI: 3008575899) has 11 FDA import refusal record(s) in our database, spanning from 7/29/2009 to 8/26/2019.
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 France's FEI number is 3008575899.
What types of violations has Sanofi Aventis France received?
Sanofi Aventis France has been cited for 7 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 France come from?
All FDA import refusal data for Sanofi Aventis 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.