LELY PHARMA BV
⚠️ High Risk
FEI: 3040793874 • Lelystad, Flevoland • NETHERLANDS
FEI Number
3040793874
Location
Lelystad, Flevoland
Country
NETHERLANDSAddress
Zuiveringweg 42, , Lelystad, Flevoland, Netherlands
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
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).
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.
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/10/2025 | 62HPA99ANTI-MICROBIAL N.E.C. | Division of West Coast Imports (DWCI) | |
| 11/10/2025 | 62LPA01CARNIDAZOLE (ANTI-PROTOZOAL, ANTI-LEISHMANIAL, ANTI-MALARIAL) | Division of West Coast Imports (DWCI) | |
| 11/10/2025 | 62LPA08RONIDAZOLE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is LELY PHARMA BV's FDA import refusal history?
LELY PHARMA BV (FEI: 3040793874) has 3 FDA import refusal record(s) in our database, spanning from 11/10/2025 to 11/10/2025.
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. LELY PHARMA BV's FEI number is 3040793874.
What types of violations has LELY PHARMA BV received?
LELY PHARMA BV has been cited for 3 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 LELY PHARMA BV come from?
All FDA import refusal data for LELY PHARMA BV 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.