Brenntag Biosector A/S
⚠️ Moderate Risk
FEI: 3003603675 • Frederikssund • DENMARK
FEI Number
3003603675
Location
Frederikssund
Country
DENMARKAddress
Elsenbakken 23, , Frederikssund, , 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
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 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
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/7/2009 | 57HC32BCG VACCINE | New York District Office (NYK-DO) | |
| 11/20/2008 | 57DC50HEPATITUS IMMUNE GLOBULIN (HUMAN) (BLOOD AND BLOOD DERIVATIVES) | New York District Office (NYK-DO) | |
| 7/28/2008 | 65ANZ99MEMORY ADJUVANT, N.E.C. | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Brenntag Biosector A/S's FDA import refusal history?
Brenntag Biosector A/S (FEI: 3003603675) has 3 FDA import refusal record(s) in our database, spanning from 7/28/2008 to 1/7/2009.
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. Brenntag Biosector A/S's FEI number is 3003603675.
What types of violations has Brenntag Biosector A/S received?
Brenntag Biosector A/S 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 Brenntag Biosector A/S come from?
All FDA import refusal data for Brenntag Biosector 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.