Sanofi - Aventis US LLC
⚠️ Moderate Risk
FEI: 1913298 • Kansas City, MO • UNITED STATES
FEI Number
1913298
Location
Kansas City, MO
Country
UNITED STATESAddress
10236 Marion Park Dr, , Kansas City, MO, 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
AGR RX
The article appears to be a prescription drug manufactured in the U.S. and offered for import by other than the manufacturer and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.
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 |
|---|---|---|---|
| 6/7/2012 | 62ODE24DILTIAZEM HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II) | 179AGR RX | New Orleans District Office (NOL-DO) |
| 5/30/2012 | 62ODE24DILTIAZEM HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II) | 179AGR RX | New Orleans District Office (NOL-DO) |
| 9/24/2003 | 56YCY99ANTIBIOTIC N.E.C. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 4/14/2003 | 64LDK52PREDNISOLONE SODIUM PHOSPHATE (GLUCOCORTICOID) | 179AGR RX | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Sanofi - Aventis US LLC's FDA import refusal history?
Sanofi - Aventis US LLC (FEI: 1913298) has 4 FDA import refusal record(s) in our database, spanning from 4/14/2003 to 6/7/2012.
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 US LLC's FEI number is 1913298.
What types of violations has Sanofi - Aventis US LLC received?
Sanofi - Aventis US LLC 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 US LLC come from?
All FDA import refusal data for Sanofi - Aventis US LLC 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.