Sanofi Aventis Parmaceutica Ltda
⚠️ High Risk
FEI: 3006549683 • Suzano, Sao Paulo • BRAZIL
FEI Number
3006549683
Location
Suzano, Sao Paulo
Country
BRAZILAddress
Rua Conde Domingos Papaiz, , Suzano, Sao Paulo, 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
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/22/2025 | 62UCY11DEXTROMETHORPHAN HYDROBROMIDE (ANTI-TUSSIVE/COLD) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/26/2025 | 54FEY94ASHWAGANDHA (HERBAL & BOTANICALS, NOT TEAS) | Division of Southeast Imports (DSEI) | |
| 11/26/2025 | 61MAY42LEVETIRACETAM (ANTI-CONVULSANT) | Division of Southeast Imports (DSEI) | |
| 4/23/2020 | 64BDY24FUROSEMIDE (DIURETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/27/2016 | 66VCB99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 5/31/2012 | 61KBA40PIPERIDOLATE HCL (ANTI-CHOLINERGIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Sanofi Aventis Parmaceutica Ltda's FDA import refusal history?
Sanofi Aventis Parmaceutica Ltda (FEI: 3006549683) has 6 FDA import refusal record(s) in our database, spanning from 5/31/2012 to 12/22/2025.
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 Parmaceutica Ltda's FEI number is 3006549683.
What types of violations has Sanofi Aventis Parmaceutica Ltda received?
Sanofi Aventis Parmaceutica 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 Parmaceutica Ltda come from?
All FDA import refusal data for Sanofi Aventis Parmaceutica 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.