Bioveta, A.S.
⚠️ Moderate Risk
FEI: 3007344531 • Ivanoviceivanovice • CZECH REPUBLIC
FEI Number
3007344531
Location
Ivanoviceivanovice
Country
CZECH REPUBLICAddress
Komenskeho 212, , Ivanoviceivanovice, , Czech Republic
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
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
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.
Refusal History
Frequently Asked Questions
What is Bioveta, A.S.'s FDA import refusal history?
Bioveta, A.S. (FEI: 3007344531) has 1 FDA import refusal record(s) in our database, spanning from 7/23/2013 to 7/23/2013.
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. Bioveta, A.S.'s FEI number is 3007344531.
What types of violations has Bioveta, A.S. received?
Bioveta, A.S. 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 Bioveta, A.S. come from?
All FDA import refusal data for Bioveta, 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.