SANOFI AVENTIS
⚠️ Moderate Risk
FEI: 3012518096 • Cali • COLOMBIA
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
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
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/11/2022 | 61TCE37AMISULPRIDE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/21/2020 | 62TDY07PANTOPRAZOLE SODIUM | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/8/2018 | 61PCL58INSULIN LISPRO PROTAMINE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/14/2016 | 61MCB42LEVETIRACETAM (ANTI-CONVULSANT) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 9/14/2016 | 61NCY99ANTI-DEPRESSANT N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is SANOFI AVENTIS's FDA import refusal history?
SANOFI AVENTIS (FEI: 3012518096) has 5 FDA import refusal record(s) in our database, spanning from 9/14/2016 to 1/11/2022.
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 3012518096.
What types of violations has SANOFI AVENTIS received?
SANOFI 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 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.