Sanofi-Aventis
⚠️ Moderate Risk
FEI: 3005574265 • Macquarie • AUSTRALIA
FEI Number
3005574265
Location
Macquarie
Country
AUSTRALIAAddress
12-24 Talavera Road, , Macquarie, , Australia
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).
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/30/2019 | 61MCR30VALPROATE SODIUM (ANTI-CONVULSANT) | Division of West Coast Imports (DWCI) | |
| 3/10/2011 | 61MCA41VALPROIC ACID (ANTI-CONVULSANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/10/2011 | 61MCA30VALPROATE SODIUM (ANTI-CONVULSANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Sanofi-Aventis's FDA import refusal history?
Sanofi-Aventis (FEI: 3005574265) has 3 FDA import refusal record(s) in our database, spanning from 3/10/2011 to 4/30/2019.
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 3005574265.
What types of violations has Sanofi-Aventis received?
Sanofi-Aventis has been cited for 3 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.