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Sanofi-Aventis Pharma Deutschland Gmbh

⚠️ Moderate Risk

FEI: 3003095474 • Bad Soden Am Taunus, Hesse • GERMANY

FEI

FEI Number

3003095474

📍

Location

Bad Soden Am Taunus, Hesse

🇩🇪

Country

GERMANY
🏢

Address

Konigsteiner Str. 10, , Bad Soden Am Taunus, Hesse, Germany

Moderate Risk

FDA Import Risk Assessment

41.6
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
10/18/2007
Latest Refusal
12/14/2001
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
3.4×10%
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

752×

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
10/18/2007
66MCB78CLOBAZAM (TRANQUILIZER)
75UNAPPROVED
New Orleans District Office (NOL-DO)
12/14/2001
62QDF99ANTI-RHEUMATIC N.E.C.
75UNAPPROVED
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Sanofi-Aventis Pharma Deutschland Gmbh's FDA import refusal history?

Sanofi-Aventis Pharma Deutschland Gmbh (FEI: 3003095474) has 2 FDA import refusal record(s) in our database, spanning from 12/14/2001 to 10/18/2007.

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-Aventis Pharma Deutschland Gmbh's FEI number is 3003095474.

What types of violations has Sanofi-Aventis Pharma Deutschland Gmbh received?

Sanofi-Aventis Pharma Deutschland Gmbh 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-Aventis Pharma Deutschland Gmbh come from?

All FDA import refusal data for Sanofi-Aventis Pharma Deutschland Gmbh 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.