Vetcur Biotec Aps
⚠️ Moderate Risk
FEI: 3009348974 • Haderslev • DENMARK
FEI Number
3009348974
Location
Haderslev
Country
DENMARKAddress
Feldumvej 35, , Haderslev, , 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
UNSAFE ADD
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain an unsafe food additive within the meaning of section 409.
FALSE
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(a)(1 ) of the FD&C Act in that the labeling is false or misleading in any particular.
NEW VET DR
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/18/2016 | 54AML99VITAMIN, N.E.C. | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 5/19/2016 | 66YPL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 72NEW VET DR | Division of Southeast Imports (DSEI) |
| 5/19/2016 | 66YPL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 72NEW VET DR | Division of Southeast Imports (DSEI) |
| 4/15/2016 | 66VPL99MISCELLANEOUS PATENT MEDICINES, ETC. | 72NEW VET DR | Cincinnati District Office (CIN-DO) |
| 8/28/2015 | 54ALT99VITAMIN, N.E.C. | Cincinnati District Office (CIN-DO) | |
| 8/28/2015 | 54ALT99VITAMIN, N.E.C. | Cincinnati District Office (CIN-DO) | |
| 8/28/2015 | 54ALT99VITAMIN, N.E.C. | Cincinnati District Office (CIN-DO) | |
| 8/28/2015 | 54ALT99VITAMIN, N.E.C. | Cincinnati District Office (CIN-DO) | |
| 8/28/2015 | 54ALT99VITAMIN, N.E.C. | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Vetcur Biotec Aps's FDA import refusal history?
Vetcur Biotec Aps (FEI: 3009348974) has 9 FDA import refusal record(s) in our database, spanning from 8/28/2015 to 8/18/2016.
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. Vetcur Biotec Aps's FEI number is 3009348974.
What types of violations has Vetcur Biotec Aps received?
Vetcur Biotec Aps 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 Vetcur Biotec Aps come from?
All FDA import refusal data for Vetcur Biotec Aps 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.