Sanofi Aventis Spa
⚠️ Moderate Risk
FEI: 3005512880 • Milan, Milan • ITALY
FEI Number
3005512880
Location
Milan, Milan
Country
ITALYAddress
Viale Luigi Bodio 37/B, , Milan, Milan, Italy
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).
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/18/2021 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/15/2020 | 62LDY29HYDROXYCHLOROQUINE SULFATE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 10/15/2019 | 54FCA99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/12/2019 | 61LBO08HEPARIN SODIUM (ANTI-COAGULANT) | Division of Southeast Imports (DSEI) | |
| 6/9/2016 | 62OCA05RAMIPRIL (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/29/2016 | 61LCY29ENOXAPARIN SODIUM (ANTI-COAGULANT) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 10/18/2011 | 80KZHINTRODUCER, SYRINGE NEEDLE | New Orleans District Office (NOL-DO) | |
| 10/18/2011 | 80KZHINTRODUCER, SYRINGE NEEDLE | New Orleans District Office (NOL-DO) | |
| 8/19/2011 | 60SCY23METOCLOPRAMIDE (ANTACID) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 8/18/2009 | 64CAL99EMETIC N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/18/2009 | 64CAL99EMETIC N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 7/29/2009 | 61HCP99ANTI-BACTERIAL, N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 6/18/2008 | 62OCA24DILTIAZEM HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Sanofi Aventis Spa's FDA import refusal history?
Sanofi Aventis Spa (FEI: 3005512880) has 13 FDA import refusal record(s) in our database, spanning from 6/18/2008 to 2/18/2021.
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 Spa's FEI number is 3005512880.
What types of violations has Sanofi Aventis Spa received?
Sanofi Aventis Spa has been cited for 4 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 Spa come from?
All FDA import refusal data for Sanofi Aventis Spa 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.