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Sanofi Winthrop Industrie

⚠️ Moderate Risk

FEI: 3004457057 • Quetigny, Cote d'Or • FRANCE

FEI

FEI Number

3004457057

📍

Location

Quetigny, Cote d'Or

🇫🇷

Country

FRANCE
🏢

Address

6 boulevard de l Europe, , Quetigny, Cote d'Or, France

Moderate Risk

FDA Import Risk Assessment

43.0
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

3
Total Refusals
1
Unique Violations
10/18/2017
Latest Refusal
11/6/2006
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
2.7×10%
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

753×

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).

Refusal History

DateProductViolationsDivision
10/18/2017
61HCA99ANTI-BACTERIAL, N.E.C.
75UNAPPROVED
Division of Southeast Imports (DSEI)
5/12/2010
61LCY38CLOPIDOGREL BISULFATE (ANTI-COAGULANT)
75UNAPPROVED
Cincinnati District Office (CIN-DO)
11/6/2006
61LDB38CLOPIDOGREL BISULFATE (ANTI-COAGULANT)
75UNAPPROVED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Sanofi Winthrop Industrie's FDA import refusal history?

Sanofi Winthrop Industrie (FEI: 3004457057) has 3 FDA import refusal record(s) in our database, spanning from 11/6/2006 to 10/18/2017.

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 3004457057.

What types of violations has Sanofi Winthrop Industrie received?

Sanofi Winthrop Industrie has been cited for 1 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.