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Sanofi Aventis Us Inc

⚠️ High Risk

FEI: 3011852213 • Bridgewater, NJ • UNITED STATES

FEI

FEI Number

3011852213

📍

Location

Bridgewater, NJ

🇺🇸
🏢

Address

1041 Us Hwy 202/206, , Bridgewater, NJ, United States

High Risk

FDA Import Risk Assessment

53.3
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

3
Total Refusals
1
Unique Violations
4/10/2024
Latest Refusal
9/19/2019
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
22.3×30%
Recency
49.8×20%
Frequency
6.6×10%
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
4/10/2024
61PCY17INSULIN (INJ) (ANTI-DIABETIC)
75UNAPPROVED
Division of Southeast Imports (DSEI)
9/16/2020
61PAL17INSULIN (INJ) (ANTI-DIABETIC)
75UNAPPROVED
Division of Southeast Imports (DSEI)
9/19/2019
61PDA31GLIMEPIRIDE (ANTI-DIABETIC)
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Sanofi Aventis Us Inc's FDA import refusal history?

Sanofi Aventis Us Inc (FEI: 3011852213) has 3 FDA import refusal record(s) in our database, spanning from 9/19/2019 to 4/10/2024.

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 Us Inc's FEI number is 3011852213.

What types of violations has Sanofi Aventis Us Inc received?

Sanofi Aventis Us Inc 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 Us Inc come from?

All FDA import refusal data for Sanofi Aventis Us Inc 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.