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Aventis Pharma

⚠️ Moderate Risk

FEI: 3003817683 • Zuerich • SWITZERLAND

FEI

FEI Number

3003817683

📍

Location

Zuerich

🇨🇭
🏢

Address

Ch-8048, , Zuerich, , Switzerland

Moderate Risk

FDA Import Risk Assessment

48.2
LowModerateHighCritical

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

Statistics

6
Total Refusals
1
Unique Violations
1/9/2007
Latest Refusal
11/22/2004
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
31.3×30%
Recency
0.0×20%
Frequency
28.1×10%
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

756×

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
1/9/2007
65QAC99RELAXANT N.E.C.
75UNAPPROVED
New Orleans District Office (NOL-DO)
11/17/2005
66MCF78CLOBAZAM (TRANQUILIZER)
75UNAPPROVED
New Orleans District Office (NOL-DO)
11/3/2005
61HBC24ISONIAZID (ANTI-BACTERIAL)
75UNAPPROVED
New Orleans District Office (NOL-DO)
11/3/2005
61HBC24ISONIAZID (ANTI-BACTERIAL)
75UNAPPROVED
New Orleans District Office (NOL-DO)
9/7/2005
61PCA99ANTI-DIABETIC N.E.C.
75UNAPPROVED
New Orleans District Office (NOL-DO)
11/22/2004
66MCA78CLOBAZAM (TRANQUILIZER)
75UNAPPROVED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Aventis Pharma's FDA import refusal history?

Aventis Pharma (FEI: 3003817683) has 6 FDA import refusal record(s) in our database, spanning from 11/22/2004 to 1/9/2007.

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. Aventis Pharma's FEI number is 3003817683.

What types of violations has Aventis Pharma received?

Aventis Pharma 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 Aventis Pharma come from?

All FDA import refusal data for Aventis Pharma 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.