Sanofi Winthrop Industrie
⚠️ Moderate Risk
FEI: 3002888606 • Centilly Cedex • FRANCE
FEI Number
3002888606
Location
Centilly Cedex
Country
FRANCEAddress
82 Ave Raspail, , Centilly Cedex, , 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).
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).
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.
NUTRIT LBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/7/2017 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/23/2012 | 66NAB03QUETIAPINE FUMARATE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/22/2008 | 03RGT01CAKE WITHOUT CUSTARD OR CREAM FILLING | 482NUTRIT LBL | New Orleans District Office (NOL-DO) |
| 4/21/2004 | 64CCS01APOMORPHINE HCL (EMETIC) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 7/29/2002 | 61LDP99ANTI-COAGULANT, 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: 3002888606) has 5 FDA import refusal record(s) in our database, spanning from 7/29/2002 to 8/7/2017.
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 3002888606.
What types of violations has Sanofi Winthrop Industrie received?
Sanofi Winthrop Industrie 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 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.