Sanofi Winthrop Industrie
⚠️ Moderate Risk
FEI: 3002972083 • Marcy-L'Etoile, Rhone • FRANCE
FEI Number
3002972083
Location
Marcy-L'Etoile, Rhone
Country
FRANCEAddress
1541 Avenue Marcel Merieux, , Marcy-L'Etoile, Rhone, 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
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).
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
Refusal History
Frequently Asked Questions
What is Sanofi Winthrop Industrie's FDA import refusal history?
Sanofi Winthrop Industrie (FEI: 3002972083) has 2 FDA import refusal record(s) in our database, spanning from 12/3/2002 to 12/5/2003.
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 3002972083.
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.