ImportRefusal LogoImportRefusal

Sanofi Aventis

⚠️ Moderate Risk

FEI: 3009737033 • Vernier, Geneva • SWITZERLAND

FEI

FEI Number

3009737033

📍

Location

Vernier, Geneva

🇨🇭
🏢

Address

route de Montfleury 3, , Vernier, Geneva, Switzerland

Moderate Risk

FDA Import Risk Assessment

46.0
LowModerateHighCritical

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

Statistics

5
Total Refusals
2
Unique Violations
10/4/2021
Latest Refusal
11/4/2014
Earliest Refusal

Score Breakdown

Violation Severity
84.3×40%
Refusal Volume
28.8×30%
Recency
14.6×20%
Frequency
7.2×10%
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

755×

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).

3422×

PERSONALRX

The article appears to be a drug which requires a prescription from your doctor.

Refusal History

DateProductViolationsDivision
10/4/2021
61NCC55SULPIRIDE (ANTI-DEPRESSANT)
75UNAPPROVED
Division of Southeast Imports (DSEI)
5/12/2020
60IBA01POTASSIUM CITRATE (ALKALIZER)
75UNAPPROVED
Division of Southeast Imports (DSEI)
2/15/2018
61NDA55SULPIRIDE (ANTI-DEPRESSANT)
75UNAPPROVED
Division of Southeast Imports (DSEI)
11/4/2014
60LCH99ANALGESIC, N.E.C.
342PERSONALRX
75UNAPPROVED
New York District Office (NYK-DO)
11/4/2014
61LCH38CLOPIDOGREL BISULFATE (ANTI-COAGULANT)
342PERSONALRX
75UNAPPROVED
New York District Office (NYK-DO)

Frequently Asked Questions

What is Sanofi Aventis's FDA import refusal history?

Sanofi Aventis (FEI: 3009737033) has 5 FDA import refusal record(s) in our database, spanning from 11/4/2014 to 10/4/2021.

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's FEI number is 3009737033.

What types of violations has Sanofi Aventis received?

Sanofi Aventis has been cited for 2 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 come from?

All FDA import refusal data for Sanofi 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.