Aventis Pharma Ltda
⚠️ Moderate Risk
FEI: 3004467407 • Sao Paulo • BRAZIL
FEI Number
3004467407
Location
Sao Paulo
Country
BRAZILAddress
Ave Marginal Do Rio Pinh. 5200, , Sao Paulo, , Brazil
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 |
|---|---|---|---|
| 6/20/2008 | 61PCB31GLIMEPIRIDE (ANTI-DIABETIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 7/20/2005 | 64BCY24FUROSEMIDE (DIURETIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 6/28/2005 | 60XCA17ATENOLOL (ANTI-ADRENERGIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/31/2005 | 62GDB99ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 2/14/2005 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Aventis Pharma Ltda's FDA import refusal history?
Aventis Pharma Ltda (FEI: 3004467407) has 5 FDA import refusal record(s) in our database, spanning from 2/14/2005 to 6/20/2008.
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. Aventis Pharma Ltda's FEI number is 3004467407.
What types of violations has Aventis Pharma Ltda received?
Aventis Pharma Ltda 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 Aventis Pharma Ltda come from?
All FDA import refusal data for Aventis Pharma 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.