Sanofi Aventis
⚠️ Moderate Risk
FEI: 3005753354 • Surrey • UNITED KINGDOM
FEI Number
3005753354
Location
Surrey
Country
UNITED KINGDOMAddress
1 Onslow Street, , Surrey, , United Kingdom
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).
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/20/2020 | 63HAA01BISACODYL (CATHARTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/13/2020 | 63HAY01BISACODYL (CATHARTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/13/2020 | 63HAA01BISACODYL (CATHARTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/29/2012 | 61LCK29ENOXAPARIN SODIUM (ANTI-COAGULANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 5/3/2012 | 62ZCY10OXALIPLATIN | Cincinnati District Office (CIN-DO) | |
| 1/13/2012 | 62LCB29HYDROXYCHLOROQUINE SULFATE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 11/15/2010 | 61MCA99ANTI-CONVULSANT, N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/28/2009 | 64UIB99INHIBITOR N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 5/24/2009 | 55QY41BENZALKONIUM CHLORIDE (PHARMACEUTIC NECESSITY - PRESERVATIVE) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 9/4/2008 | 61LCP29ENOXAPARIN SODIUM (ANTI-COAGULANT) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 3/27/2007 | 60NCF13STANOZOLOL (ANDROGEN) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Sanofi Aventis's FDA import refusal history?
Sanofi Aventis (FEI: 3005753354) has 11 FDA import refusal record(s) in our database, spanning from 3/27/2007 to 6/20/2020.
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 3005753354.
What types of violations has Sanofi Aventis received?
Sanofi Aventis 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 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.