AbbVie Deutschland GmbH & Co. KG
⚠️ High Risk
FEI: 3002807401 • Ludwigshafen, Rhineland-Palatinate • GERMANY
FEI Number
3002807401
Location
Ludwigshafen, Rhineland-Palatinate
Country
GERMANYAddress
Knollstrasse, , Ludwigshafen, Rhineland-Palatinate, 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/31/2025 | 58MCY09RISANKIZUMAB-RZAA | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/9/2025 | 58MCK09RISANKIZUMAB-RZAA | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/11/2025 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/8/2025 | 66VIY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/13/2024 | 58SCK14ADALIMUMAB | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/31/2023 | 61YCY02ADALIMUMAB | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/8/2020 | 61YDY02ADALIMUMAB | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/8/2020 | 61YDY02ADALIMUMAB | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/5/2017 | 62VCB79LOPINAVIR; RITONAVIR (ANTI-VIRAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/27/2011 | 62CCA99ANTI-HYPERTENSIVE N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/1/2008 | 60RCE19SIBUTRAMINE HCL MONOHYDRATE (ANOREXIC) | San Francisco District Office (SAN-DO) | |
| 5/1/2007 | 60RLE19SIBUTRAMINE HCL MONOHYDRATE (ANOREXIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/9/2007 | 60RCH19SIBUTRAMINE HCL MONOHYDRATE (ANOREXIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 6/26/2006 | 60RRC19SIBUTRAMINE HCL MONOHYDRATE (ANOREXIC) | 75UNAPPROVED | Seattle District Office (SEA-DO) |
| 12/12/2003 | 62OIY29ENALAPRILATE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/12/2003 | 62OIY29ENALAPRILATE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/12/2003 | 62OIY29ENALAPRILATE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/12/2003 | 62OIY29ENALAPRILATE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/12/2003 | 62OIY29ENALAPRILATE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/12/2003 | 62OIY29ENALAPRILATE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/12/2003 | 62OIY29ENALAPRILATE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/28/2002 | 66VIP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is AbbVie Deutschland GmbH & Co. KG's FDA import refusal history?
AbbVie Deutschland GmbH & Co. KG (FEI: 3002807401) has 22 FDA import refusal record(s) in our database, spanning from 2/28/2002 to 12/31/2025.
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. AbbVie Deutschland GmbH & Co. KG's FEI number is 3002807401.
What types of violations has AbbVie Deutschland GmbH & Co. KG received?
AbbVie Deutschland GmbH & Co. KG 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 AbbVie Deutschland GmbH & Co. KG come from?
All FDA import refusal data for AbbVie Deutschland GmbH & Co. KG 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.