Abbvie Biotechnology Gmbh
🚨 Critical Risk
FEI: 3011277200 • Ludwigshafen Am Rhein, Rhineland-Palatinate • GERMANY
FEI Number
3011277200
Location
Ludwigshafen Am Rhein, Rhineland-Palatinate
Country
GERMANYAddress
Knollstr. 50, , Ludwigshafen Am Rhein, Rhineland-Palatinate, Germany
Critical Risk
FDA Import Risk Assessment
This firm has an extensive history of FDA import refusals with severe 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).
DIRSEXMPT
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use.
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.
NO LICENSE
The article is subject to refusal of admission under section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because it appears to be a biological product for which a biologics license is not in effect under the Public Health Service Act, Part F, Subpart 1-Biological Products, Section 351(a), and it is not the subject of an Investigational New Drug application that is in effect. Therefore, it appears to be a new drug under 201(p) of the FD&C Act that it is in violation of section 505(a) of the FD&C Act because it lacks a new drug approval and because it is misbranded under section 502(f)(1)of the FD&C Act because it fails to bear adequate directions for use
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/22/2026 | 58SCY14ADALIMUMAB | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/18/2026 | 62QCL99ANTI-RHEUMATIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/18/2026 | 58SCY14ADALIMUMAB | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/14/2025 | 58SCK14ADALIMUMAB | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/19/2025 | 58SCY14ADALIMUMAB | Division of Southeast Imports (DSEI) | |
| 9/26/2025 | 58SCP14ADALIMUMAB | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/3/2025 | 58MCY09RISANKIZUMAB-RZAA | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 8/22/2025 | 58SCY14ADALIMUMAB | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/4/2025 | 61PCY99ANTI-DIABETIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/24/2025 | 58SDY14ADALIMUMAB | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/24/2025 | 58SCY14ADALIMUMAB | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/30/2024 | 58SDY14ADALIMUMAB | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/30/2024 | 58SCK14ADALIMUMAB | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/27/2024 | 58SCL14ADALIMUMAB | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/27/2024 | 66VIY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/27/2024 | 58SCK14ADALIMUMAB | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/26/2024 | 58SCK14ADALIMUMAB | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/14/2024 | 58SCY14ADALIMUMAB | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/14/2024 | 58SCK14ADALIMUMAB | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/9/2024 | 58SCY14ADALIMUMAB | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/17/2024 | 58SCY14ADALIMUMAB | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/15/2024 | 58SCY14ADALIMUMAB | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/17/2024 | 58SCY14ADALIMUMAB | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/4/2024 | 61YCI02ADALIMUMAB | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/5/2023 | 61YDY02ADALIMUMAB | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/7/2023 | 61YCY02ADALIMUMAB | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/30/2023 | 61YCY02ADALIMUMAB | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/9/2021 | 61YCL02ADALIMUMAB | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is Abbvie Biotechnology Gmbh's FDA import refusal history?
Abbvie Biotechnology Gmbh (FEI: 3011277200) has 28 FDA import refusal record(s) in our database, spanning from 2/9/2021 to 1/22/2026.
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 Biotechnology Gmbh's FEI number is 3011277200.
What types of violations has Abbvie Biotechnology Gmbh received?
Abbvie Biotechnology Gmbh has been cited for 5 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 Biotechnology Gmbh come from?
All FDA import refusal data for Abbvie Biotechnology 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.