VIOVET LTD
⚠️ High Risk
FEI: 3012394349 • Luton • UNITED KINGDOM
FEI Number
3012394349
Location
Luton
Country
UNITED KINGDOMAddress
53 Bilton Way, , Luton, , United Kingdom
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable 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
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.
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).
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/22/2024 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northeast Imports (DNEI) | |
| 4/5/2024 | 66VQA99MISCELLANEOUS PATENT MEDICINES, ETC. | 72NEW VET DR | Division of Northeast Imports (DNEI) |
| 3/7/2023 | 60DLY01DESOXYCORTICOSTERONE ACETATE (ADRENOCORTICAL STEROID) | 72NEW VET DR | Division of Southeast Imports (DSEI) |
| 3/1/2023 | 60DLY01DESOXYCORTICOSTERONE ACETATE (ADRENOCORTICAL STEROID) | 72NEW VET DR | Division of Southeast Imports (DSEI) |
| 11/10/2022 | 65JLA99PROGESTIN N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/19/2021 | 66VQA99MISCELLANEOUS PATENT MEDICINES, ETC. | 72NEW VET DR | Division of Southeast Imports (DSEI) |
| 8/19/2021 | 66VQA99MISCELLANEOUS PATENT MEDICINES, ETC. | 72NEW VET DR | Division of Southeast Imports (DSEI) |
| 8/30/2017 | 79MNFIMPLANT, TEMPORAL | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 8/29/2017 | 62VPY99ANTI-VIRAL N.E.C. | 72NEW VET DR | Division of Southeast Imports (DSEI) |
| 8/22/2017 | 66VLD99MISCELLANEOUS PATENT MEDICINES, ETC. | 72NEW VET DR | Division of Southeast Imports (DSEI) |
| 2/21/2017 | 68YCA10SMALL ANIMAL ANIMAL DRUGS N.E.C. | 72NEW VET DR | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is VIOVET LTD's FDA import refusal history?
VIOVET LTD (FEI: 3012394349) has 11 FDA import refusal record(s) in our database, spanning from 2/21/2017 to 7/22/2024.
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. VIOVET LTD's FEI number is 3012394349.
What types of violations has VIOVET LTD received?
VIOVET LTD 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 VIOVET LTD come from?
All FDA import refusal data for VIOVET LTD 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.