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Laboratoire Aventis

⚠️ Moderate Risk

FEI: 3003414667 • Paris, Paris • FRANCE

FEI

FEI Number

3003414667

📍

Location

Paris, Paris

🇫🇷

Country

FRANCE
🏢

Address

46 Quai De La Rapee, , Paris, Paris, France

Moderate Risk

FDA Import Risk Assessment

43.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
1
Unique Violations
8/21/2008
Latest Refusal
7/22/2005
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
9.7×10%
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
8/21/2008
64SCP29ZOPICLONE
75UNAPPROVED
New Orleans District Office (NOL-DO)
5/8/2006
60LCA84LEFLUNOMIDE (ANALGESIC)
75UNAPPROVED
New Orleans District Office (NOL-DO)
7/22/2005
61PCP99ANTI-DIABETIC N.E.C.
75UNAPPROVED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Laboratoire Aventis's FDA import refusal history?

Laboratoire Aventis (FEI: 3003414667) has 3 FDA import refusal record(s) in our database, spanning from 7/22/2005 to 8/21/2008.

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. Laboratoire Aventis's FEI number is 3003414667.

What types of violations has Laboratoire Aventis received?

Laboratoire Aventis 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 Laboratoire Aventis come from?

All FDA import refusal data for Laboratoire Aventis 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.