KVP Pharma Veterin Produkte GmbH
⚠️ High Risk
FEI: 3004159824 • Kiel, Schleswig-Holstein • GERMANY
FEI Number
3004159824
Location
Kiel, Schleswig-Holstein
Country
GERMANYAddress
Projensdorfer Str. 324, , Kiel, Schleswig-Holstein, Germany
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 |
|---|---|---|---|
| 11/1/2024 | 65RPL99REPLENISHER N.E.C. | 72NEW VET DR | Division of Southeast Imports (DSEI) |
| 11/1/2024 | 65RPL99REPLENISHER N.E.C. | 72NEW VET DR | Division of Southeast Imports (DSEI) |
| 11/1/2024 | 65RPL99REPLENISHER N.E.C. | 72NEW VET DR | Division of Southeast Imports (DSEI) |
| 5/1/2024 | 60ZKL14IMIDACLOPRID AND COMBINATIONS (ANTIPARASITIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/17/2023 | 56OQA05ENROFLOXACIN (FLUOROQUINOLONE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is KVP Pharma Veterin Produkte GmbH's FDA import refusal history?
KVP Pharma Veterin Produkte GmbH (FEI: 3004159824) has 5 FDA import refusal record(s) in our database, spanning from 3/17/2023 to 11/1/2024.
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. KVP Pharma Veterin Produkte GmbH's FEI number is 3004159824.
What types of violations has KVP Pharma Veterin Produkte GmbH received?
KVP Pharma Veterin Produkte GmbH 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 KVP Pharma Veterin Produkte GmbH come from?
All FDA import refusal data for KVP Pharma Veterin Produkte GmbH 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.