SANOFI AVENTIS FARMACEUTICA LTDA
⚠️ High Risk
FEI: 3014477845 • Suzano • BRAZIL
FEI Number
3014477845
Location
Suzano
Country
BRAZILAddress
Rua Conde De Domingos Papais 413 Deposito, F200, , Suzano, , Brazil
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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).
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
Refusal History
Frequently Asked Questions
What is SANOFI AVENTIS FARMACEUTICA LTDA's FDA import refusal history?
SANOFI AVENTIS FARMACEUTICA LTDA (FEI: 3014477845) has 3 FDA import refusal record(s) in our database, spanning from 12/16/2022 to 7/31/2025.
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 FARMACEUTICA LTDA's FEI number is 3014477845.
What types of violations has SANOFI AVENTIS FARMACEUTICA LTDA received?
SANOFI AVENTIS FARMACEUTICA LTDA 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 FARMACEUTICA LTDA come from?
All FDA import refusal data for SANOFI AVENTIS FARMACEUTICA LTDA 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.