COLUMBOVET SRL
⚠️ High Risk
FEI: 3024771409 • Oradea, Bihor • ROMANIA
FEI Number
3024771409
Location
Oradea, Bihor
Country
ROMANIAAddress
Strada Baba Corneliu 9, , Oradea, Bihor, Romania
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.
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 |
|---|---|---|---|
| 9/17/2024 | 61HQY03TRIMETHOPRIM (ANTI-BACTERIAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/17/2024 | 62LQY01CARNIDAZOLE (ANTI-PROTOZOAL, ANTI-LEISHMANIAL, ANTI-MALARIAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/17/2024 | 54FNY99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 72NEW VET DR | Division of Southeast Imports (DSEI) |
| 9/17/2024 | 54FRY99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 72NEW VET DR | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is COLUMBOVET SRL's FDA import refusal history?
COLUMBOVET SRL (FEI: 3024771409) has 4 FDA import refusal record(s) in our database, spanning from 9/17/2024 to 9/17/2024.
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. COLUMBOVET SRL's FEI number is 3024771409.
What types of violations has COLUMBOVET SRL received?
COLUMBOVET SRL has been cited for 2 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 COLUMBOVET SRL come from?
All FDA import refusal data for COLUMBOVET SRL 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.