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Aventis Pharma

⚠️ Moderate Risk

FEI: 3005059581 • Alexandria, Alexandria • EGYPT

FEI

FEI Number

3005059581

📍

Location

Alexandria, Alexandria

🇪🇬

Country

EGYPT
🏢

Address

20 Mohamed Egypt Louran, , Alexandria, Alexandria, Egypt

Moderate Risk

FDA Import Risk Assessment

43.8
LowModerateHighCritical

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

Statistics

3
Total Refusals
1
Unique Violations
3/6/2008
Latest Refusal
5/31/2005
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
10.8×10%
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
3/6/2008
64MCB01CLOMIPHENE CITRATE (GONAD-STIMULATING PRINCIPLE)
75UNAPPROVED
New Orleans District Office (NOL-DO)
1/22/2008
66VCY99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
New Orleans District Office (NOL-DO)
5/31/2005
66VCP99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Aventis Pharma's FDA import refusal history?

Aventis Pharma (FEI: 3005059581) has 3 FDA import refusal record(s) in our database, spanning from 5/31/2005 to 3/6/2008.

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 3005059581.

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.