Sanofi-Aventis Deutschland GmbH
⚠️ High Risk
FEI: 3003195501 • Frankfurt Am Main, Hassia • GERMANY
FEI Number
3003195501
Location
Frankfurt Am Main, Hassia
Country
GERMANYAddress
Industriepark Hochst, Bruningstr. 50, Frankfurt Am Main, Hassia, Germany
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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.
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/5/2025 | 58ACK02DUPILUMAB | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/30/2025 | 61PCL17INSULIN (INJ) (ANTI-DIABETIC) | Division of Northeast Imports (DNEI) | |
| 10/30/2025 | 58HCL09INSULIN GLARGINE | Division of Northeast Imports (DNEI) | |
| 4/14/2025 | 61PCY17INSULIN (INJ) (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/4/2025 | 58ACY02DUPILUMAB | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/4/2025 | 58ADY02DUPILUMAB | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/13/2025 | 58ADY02DUPILUMAB | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/24/2025 | 61ECL99ANTI-ASTHMATIC, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/10/2024 | 58ADL02DUPILUMAB | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/26/2023 | 64BDB24FUROSEMIDE (DIURETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/27/2023 | 60LCA84LEFLUNOMIDE (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/27/2022 | 61PCY17INSULIN (INJ) (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/19/2021 | 61PDL17INSULIN (INJ) (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/19/2021 | 61PDL17INSULIN (INJ) (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/2/2021 | 61PCA17INSULIN (INJ) (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/29/2020 | 61PCL17INSULIN (INJ) (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/8/2020 | 66VCB99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/3/2020 | 61PCL17INSULIN (INJ) (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/23/2018 | 80NSCINJECTOR, PEN | Division of Southeast Imports (DSEI) | |
| 2/16/2018 | 61PCY17INSULIN (INJ) (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/27/2017 | 61PCK17INSULIN (INJ) (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/27/2017 | 61PCL17INSULIN (INJ) (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/27/2017 | 61PCL17INSULIN (INJ) (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/24/2017 | 61PCP17INSULIN (INJ) (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/28/2016 | 60LBK99ANALGESIC, N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 8/24/2016 | 61PDC26METFORMIN (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/24/2016 | 62ODC14AMLODIPINE BESYLATE (ANTI-HYPERTENSIVE, PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/22/2016 | 61LBK29ENOXAPARIN SODIUM (ANTI-COAGULANT) | Florida District Office (FLA-DO) | |
| 10/29/2015 | 61PCK17INSULIN (INJ) (ANTI-DIABETIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/28/2015 | 61PCY17INSULIN (INJ) (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/22/2015 | 61LBK29ENOXAPARIN SODIUM (ANTI-COAGULANT) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 7/22/2015 | 61HBL43LEVOFLOXACIN (ANTI-BACTERIAL, PART III) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 7/22/2015 | 61LBK29ENOXAPARIN SODIUM (ANTI-COAGULANT) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 7/22/2015 | 61PBK34INSULIN BIOSYNTHETIC HUMAN & SUSP ISOPHANE (ANTI-DIABETIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 2/23/2015 | 61HBL43LEVOFLOXACIN (ANTI-BACTERIAL, PART III) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 2/11/2014 | 61LCP29ENOXAPARIN SODIUM (ANTI-COAGULANT) | Cincinnati District Office (CIN-DO) | |
| 8/12/2013 | 61PCY17INSULIN (INJ) (ANTI-DIABETIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 6/4/2012 | 61PCK17INSULIN (INJ) (ANTI-DIABETIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 9/30/2011 | 61PAK17INSULIN (INJ) (ANTI-DIABETIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 9/7/2011 | 66VIP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/19/2011 | 64RCW99HORMONE N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/31/2011 | 66BLH99STIMULANT N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 9/13/2010 | 66MDB78CLOBAZAM (TRANQUILIZER) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/29/2010 | 60TIK99ANTAGONIST, N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 6/18/2008 | 61TCA12METOCLOPRAMIDE HCL (ANTI-EMETIC/NAUSEANT) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 6/18/2008 | 61TCA12METOCLOPRAMIDE HCL (ANTI-EMETIC/NAUSEANT) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 6/18/2008 | 61NCA55SULPIRIDE (ANTI-DEPRESSANT) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 3/12/2008 | 62ZCA10OXALIPLATIN | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/28/2007 | 61PCK17INSULIN (INJ) (ANTI-DIABETIC) | San Francisco District Office (SAN-DO) | |
| 8/16/2007 | 61GCY85OFLOXACIN (ANTI-BACTERIAL, PART II) (NOT ANTIBIOTIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/24/2006 | 61EAY06FEXOFENADINE HCL (ANTI-ASTHMATIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 11/22/2004 | 62ICP99ANTI-NEOPLASTIC N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 11/18/2002 | 64BCC24FUROSEMIDE (DIURETIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/11/2002 | 60CCS42LEVONORDEFRIN (ADRENERGIC) | 16DIRECTIONS | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Sanofi-Aventis Deutschland GmbH's FDA import refusal history?
Sanofi-Aventis Deutschland GmbH (FEI: 3003195501) has 54 FDA import refusal record(s) in our database, spanning from 2/11/2002 to 12/5/2025.
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 Deutschland GmbH's FEI number is 3003195501.
What types of violations has Sanofi-Aventis Deutschland GmbH received?
Sanofi-Aventis Deutschland GmbH has been cited for 6 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 Deutschland GmbH come from?
All FDA import refusal data for Sanofi-Aventis Deutschland GmbH 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.