Eldon Biologicals A/S
⚠️ Moderate Risk
FEI: 3003783142 • Gentofte, Hovedstaden • DENMARK
FEI Number
3003783142
Location
Gentofte, Hovedstaden
Country
DENMARKAddress
Sandtoften 10, , Gentofte, Hovedstaden, Denmark
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
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
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.
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 |
|---|---|---|---|
| 11/9/2023 | 81KSZSYSTEM, TEST, AUTOMATED BLOOD GROUPING AND ANTIBODY | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 10/4/2022 | 81KSZSYSTEM, TEST, AUTOMATED BLOOD GROUPING AND ANTIBODY | 341REGISTERED | Division of Northern Border Imports (DNBI) |
| 10/4/2022 | 81KSZSYSTEM, TEST, AUTOMATED BLOOD GROUPING AND ANTIBODY | 341REGISTERED | Division of Northern Border Imports (DNBI) |
| 9/21/2022 | 81KSZSYSTEM, TEST, AUTOMATED BLOOD GROUPING AND ANTIBODY | Division of Northern Border Imports (DNBI) | |
| 9/1/2022 | 81KSZSYSTEM, TEST, AUTOMATED BLOOD GROUPING AND ANTIBODY | 341REGISTERED | Division of Northern Border Imports (DNBI) |
| 3/29/2013 | 81KSZSYSTEM, TEST, AUTOMATED BLOOD GROUPING AND ANTIBODY | 341REGISTERED | New Orleans District Office (NOL-DO) |
| 7/9/2007 | 73CBTKIT, SAMPLING, ARTERIAL BLOOD | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 7/6/2007 | 57DG42BLOOD GROUP SPECIFIC SUBSTANCES A AND B (BLOOD AND BLOOD DERIVATIVES) | 71NO LICENSE | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Eldon Biologicals A/S's FDA import refusal history?
Eldon Biologicals A/S (FEI: 3003783142) has 8 FDA import refusal record(s) in our database, spanning from 7/6/2007 to 11/9/2023.
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. Eldon Biologicals A/S's FEI number is 3003783142.
What types of violations has Eldon Biologicals A/S received?
Eldon Biologicals A/S 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 Eldon Biologicals A/S come from?
All FDA import refusal data for Eldon Biologicals A/S 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.