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SANOFI AVENTIS INDUSTRIE

⚠️ Moderate Risk

FEI: 3012739398 • Gentilly, Val de Marne • FRANCE

FEI

FEI Number

3012739398

📍

Location

Gentilly, Val de Marne

🇫🇷

Country

FRANCE
🏢

Address

82 avenue Raspail, , Gentilly, Val de Marne, France

Moderate Risk

FDA Import Risk Assessment

44.5
LowModerateHighCritical

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

Statistics

3
Total Refusals
1
Unique Violations
10/11/2018
Latest Refusal
2/7/2017
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
17.9×10%
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
10/11/2018
56CDL64CEFPODOXIME PROXETIL (CEPHALOSPORINS)
75UNAPPROVED
Division of Southeast Imports (DSEI)
4/28/2017
64SAA29ZOPICLONE
75UNAPPROVED
Division of Southeast Imports (DSEI)
2/7/2017
64HDL02GUAIFENESIN (EXPECTORANT)
75UNAPPROVED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is SANOFI AVENTIS INDUSTRIE's FDA import refusal history?

SANOFI AVENTIS INDUSTRIE (FEI: 3012739398) has 3 FDA import refusal record(s) in our database, spanning from 2/7/2017 to 10/11/2018.

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 INDUSTRIE's FEI number is 3012739398.

What types of violations has SANOFI AVENTIS INDUSTRIE received?

SANOFI AVENTIS 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 AVENTIS INDUSTRIE come from?

All FDA import refusal data for SANOFI AVENTIS 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.