Sanofi Winthrop Industrie
⚠️ High Risk
FEI: 3003259844 • Le Trait, Seine-Maritime • FRANCE
FEI Number
3003259844
Location
Le Trait, Seine-Maritime
Country
FRANCEAddress
1051 Boulevard Industriel, , Le Trait, Seine-Maritime, 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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/3/2025 | 58ACY02DUPILUMAB | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 10/12/2012 | 61LDA38CLOPIDOGREL BISULFATE (ANTI-COAGULANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/19/2012 | 62GIK99ANTI-INFLAMMATORY N.E.C. | New York District Office (NYK-DO) | |
| 1/19/2012 | 62GIK99ANTI-INFLAMMATORY N.E.C. | New York District Office (NYK-DO) | |
| 1/19/2012 | 62GIK99ANTI-INFLAMMATORY N.E.C. | New York District Office (NYK-DO) | |
| 1/3/2012 | 62GIK99ANTI-INFLAMMATORY N.E.C. | New York District Office (NYK-DO) | |
| 1/3/2012 | 64UIK99INHIBITOR N.E.C. | New York District Office (NYK-DO) | |
| 1/3/2012 | 64UIK99INHIBITOR N.E.C. | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Sanofi Winthrop Industrie's FDA import refusal history?
Sanofi Winthrop Industrie (FEI: 3003259844) has 8 FDA import refusal record(s) in our database, spanning from 1/3/2012 to 9/3/2025.
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 3003259844.
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.