Sanofi Winthrop Industrie
⚠️ High Risk
FEI: 3002808208 • Carbon Blanc CEDEX, Gironde • FRANCE
FEI Number
3002808208
Location
Carbon Blanc CEDEX, Gironde
Country
FRANCEAddress
Sanofi, 1 rue de la Vierge; Ambares Et Lagrave, Carbon Blanc CEDEX, Gironde, 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).
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 |
|---|---|---|---|
| 12/17/2025 | 61LCA38CLOPIDOGREL BISULFATE (ANTI-COAGULANT) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 5/12/2022 | 65PCA02SILDENAFIL CITRATE (REGULATOR) | Division of Southeast Imports (DSEI) | |
| 5/12/2022 | 65PCA02SILDENAFIL CITRATE (REGULATOR) | Division of Southeast Imports (DSEI) | |
| 5/12/2022 | 65PCA02SILDENAFIL CITRATE (REGULATOR) | Division of Southeast Imports (DSEI) | |
| 6/30/2021 | 61LCY38CLOPIDOGREL BISULFATE (ANTI-COAGULANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/2/2021 | 61LDA38CLOPIDOGREL BISULFATE (ANTI-COAGULANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/19/2020 | 62OCE37IRBESARTAN (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/26/2018 | 62ODA37IRBESARTAN (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/18/2016 | 62ODH37IRBESARTAN (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/16/2016 | 62OCA37IRBESARTAN (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 6/17/2015 | 61LDB38CLOPIDOGREL BISULFATE (ANTI-COAGULANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 11/21/2011 | 61LCB38CLOPIDOGREL BISULFATE (ANTI-COAGULANT) | Division of Southeast Imports (DSEI) | |
| 8/14/2008 | 61LDC38CLOPIDOGREL BISULFATE (ANTI-COAGULANT) | 118NOT LISTED | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is Sanofi Winthrop Industrie's FDA import refusal history?
Sanofi Winthrop Industrie (FEI: 3002808208) has 13 FDA import refusal record(s) in our database, spanning from 8/14/2008 to 12/17/2025.
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 Winthrop Industrie's FEI number is 3002808208.
What types of violations has Sanofi Winthrop Industrie received?
Sanofi Winthrop Industrie 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 Sanofi Winthrop Industrie come from?
All FDA import refusal data for Sanofi Winthrop Industrie 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.