Sanofi Winthrop Industrie
⚠️ High Risk
FEI: 3003282644 • Tours, Indre Et Loire • FRANCE
FEI Number
3003282644
Location
Tours, Indre Et Loire
Country
FRANCEAddress
30 avenue Gustave Eiffel, , Tours, Indre Et Loire, 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 |
|---|---|---|---|
| 9/3/2025 | 66WCA99IMMUNOMODULATOR N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 4/28/2020 | 65VCY56ZOLPIDEM TARTRATE (SEDATIVE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/30/2017 | 60LBK99ANALGESIC, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/28/2016 | 60LBK99ANALGESIC, N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 11/28/2016 | 60LBK99ANALGESIC, N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 11/28/2016 | 60LBK99ANALGESIC, N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 11/28/2016 | 60LBK99ANALGESIC, N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 11/28/2016 | 60LBK99ANALGESIC, N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 11/28/2016 | 60LBK99ANALGESIC, N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 11/28/2016 | 60LBK99ANALGESIC, N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 11/28/2016 | 60LBK99ANALGESIC, N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 11/28/2016 | 60LBK99ANALGESIC, N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 11/28/2016 | 60LBK99ANALGESIC, N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 11/28/2016 | 60LBK99ANALGESIC, N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 11/5/2015 | 61LBK29ENOXAPARIN SODIUM (ANTI-COAGULANT) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 7/22/2015 | 61PBC31GLIMEPIRIDE (ANTI-DIABETIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 7/22/2015 | 61MBY41VALPROIC ACID (ANTI-CONVULSANT) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 7/22/2015 | 61LBK29ENOXAPARIN SODIUM (ANTI-COAGULANT) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 7/22/2015 | 65JBJ11ETHISTERONE (PROGESTIN) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 7/22/2015 | 60SBL23METOCLOPRAMIDE (ANTACID) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 7/22/2015 | 65JBJ11ETHISTERONE (PROGESTIN) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 7/22/2015 | 61PBC31GLIMEPIRIDE (ANTI-DIABETIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 7/22/2015 | 60SBL23METOCLOPRAMIDE (ANTACID) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 7/22/2015 | 61LBC38CLOPIDOGREL BISULFATE (ANTI-COAGULANT) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 7/22/2015 | 61MBL30VALPROATE SODIUM (ANTI-CONVULSANT) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 7/22/2015 | 61LBC38CLOPIDOGREL BISULFATE (ANTI-COAGULANT) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 7/22/2015 | 61LBK29ENOXAPARIN SODIUM (ANTI-COAGULANT) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 7/22/2015 | 61PBC31GLIMEPIRIDE (ANTI-DIABETIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 2/24/2015 | 65CBK01ADENOSINE PHOSPHATE (NUTRIENT/TONIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 2/24/2015 | 61MBL30VALPROATE SODIUM (ANTI-CONVULSANT) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 2/24/2015 | 60SBL23METOCLOPRAMIDE (ANTACID) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 2/24/2015 | 61NBC55SULPIRIDE (ANTI-DEPRESSANT) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 2/24/2015 | 63EBK19AMIODARONE HYDROCHLORIDE (CARDIAC DEPRESSANT (ANTI-ARRHYTHMIC)) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 2/24/2015 | 61LBJ08HEPARIN SODIUM (ANTI-COAGULANT) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 2/24/2015 | 61LBC38CLOPIDOGREL BISULFATE (ANTI-COAGULANT) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 2/24/2015 | 61LBK29ENOXAPARIN SODIUM (ANTI-COAGULANT) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 2/24/2015 | 62OBC37IRBESARTAN (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 2/24/2015 | 60WBC16MEBENDAZOLE (ANTHELMINTIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 2/24/2015 | 61PBC31GLIMEPIRIDE (ANTI-DIABETIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 2/23/2015 | 61LBC38CLOPIDOGREL BISULFATE (ANTI-COAGULANT) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 2/23/2015 | 60SBY15MAGNESIUM PHOSPHATE (ANTACID) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 2/23/2015 | 61MBL30VALPROATE SODIUM (ANTI-CONVULSANT) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 1/12/2012 | 65QCB99RELAXANT N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/27/2011 | 62ORB24DILTIAZEM HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 11/2/2009 | 66VDA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 6/17/2007 | 62VRB30INDINAVIR SULFATE (ANTI-VIRAL) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/24/2006 | 65VCB56ZOLPIDEM TARTRATE (SEDATIVE) | 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: 3003282644) has 47 FDA import refusal record(s) in our database, spanning from 10/24/2006 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 3003282644.
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.