Sanofi-Aventis
⚠️ Moderate Risk
FEI: 3005167197 • Bridgewater, NJ • UNITED STATES
FEI Number
3005167197
Location
Bridgewater, NJ
Country
UNITED STATESAddress
Room L-320b, Route 202-206, Bridgewater, NJ, United States
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 |
|---|---|---|---|
| 10/28/2011 | 61LCX29ENOXAPARIN SODIUM (ANTI-COAGULANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/5/2011 | 61LCK29ENOXAPARIN SODIUM (ANTI-COAGULANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 7/26/2010 | 62UCY99ANTI-TUSSIVE/COLD N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 7/26/2010 | 62UCY99ANTI-TUSSIVE/COLD N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Sanofi-Aventis's FDA import refusal history?
Sanofi-Aventis (FEI: 3005167197) has 4 FDA import refusal record(s) in our database, spanning from 7/26/2010 to 10/28/2011.
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 3005167197.
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.