CSL Behring GmbH
⚠️ Moderate Risk
FEI: 3003098680 • Marburg, Hassia • GERMANY
FEI Number
3003098680
Location
Marburg, Hassia
Country
GERMANYAddress
Emil-Von-Behring-Str. 76, , Marburg, Hassia, Germany
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
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
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/15/2018 | 57CH29VARICELLA VIRUS VACCINE | Division of Southeast Imports (DSEI) | |
| 3/9/2018 | 57UH06TETANUS IMMUNE GLOBULIN | 71NO LICENSE | Division of Southeast Imports (DSEI) |
| 2/26/2018 | 57UH06TETANUS IMMUNE GLOBULIN | 71NO LICENSE | Division of Southeast Imports (DSEI) |
| 10/25/2005 | 88LDTREAGENT, GENERAL PURPOSE | New Orleans District Office (NOL-DO) | |
| 10/25/2005 | 57DY03ANTIHEMOPHILIC FACTOR (HUMAN) (BLOOD AND BLOOD DERIVATIVES) | 71NO LICENSE | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is CSL Behring GmbH's FDA import refusal history?
CSL Behring GmbH (FEI: 3003098680) has 5 FDA import refusal record(s) in our database, spanning from 10/25/2005 to 5/15/2018.
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. CSL Behring GmbH's FEI number is 3003098680.
What types of violations has CSL Behring GmbH received?
CSL Behring GmbH has been cited for 3 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 CSL Behring GmbH come from?
All FDA import refusal data for CSL Behring 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.