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SANOFI AVENTIS DE MEXICO SA DE C

⚠️ High Risk

FEI: 3039080249 • Ciudad De Mexico, CP • MEXICO

FEI

FEI Number

3039080249

📍

Location

Ciudad De Mexico, CP

🇲🇽

Country

MEXICO
🏢

Address

Av Real De Mayorazgo To, Co Benito Juarez, Ciudad De Mexico, CP, Mexico

High Risk

FDA Import Risk Assessment

59.0
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
9/17/2025
Latest Refusal
9/17/2025
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
11.2×30%
Recency
93.5×20%
Frequency
10.0×10%
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

751×

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
9/17/2025
64BDE24FUROSEMIDE (DIURETIC)
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is SANOFI AVENTIS DE MEXICO SA DE C's FDA import refusal history?

SANOFI AVENTIS DE MEXICO SA DE C (FEI: 3039080249) has 1 FDA import refusal record(s) in our database, spanning from 9/17/2025 to 9/17/2025.

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 DE MEXICO SA DE C's FEI number is 3039080249.

What types of violations has SANOFI AVENTIS DE MEXICO SA DE C received?

SANOFI AVENTIS DE MEXICO SA DE C 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 DE MEXICO SA DE C come from?

All FDA import refusal data for SANOFI AVENTIS DE MEXICO SA DE C 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.