Lelypharma BV
⚠️ High Risk
FEI: 3015660451 • Lelystad, Flevoland • NETHERLANDS
FEI Number
3015660451
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
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).
DIRSEXMPT
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use.
FALSEDRUG
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug which is misbranded within the meaning of section 502(a)(1) in that its labeling is false or misleading.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/17/2025 | 61XBL21DOXYLAMINE SUCCINATE (ANTI-HISTAMINIC) | Division of Northern Border Imports (DNBI) | |
| 1/17/2025 | 61XBL21DOXYLAMINE SUCCINATE (ANTI-HISTAMINIC) | Division of Northern Border Imports (DNBI) | |
| 1/17/2025 | 61XBL21DOXYLAMINE SUCCINATE (ANTI-HISTAMINIC) | Division of Northern Border Imports (DNBI) | |
| 1/17/2025 | 61XBL21DOXYLAMINE SUCCINATE (ANTI-HISTAMINIC) | Division of Northern Border Imports (DNBI) | |
| 1/17/2025 | 61XBL21DOXYLAMINE SUCCINATE (ANTI-HISTAMINIC) | Division of Northern Border Imports (DNBI) | |
| 1/17/2025 | 61XBL21DOXYLAMINE SUCCINATE (ANTI-HISTAMINIC) | Division of Northern Border Imports (DNBI) | |
| 1/17/2025 | 61XBL21DOXYLAMINE SUCCINATE (ANTI-HISTAMINIC) | Division of Northern Border Imports (DNBI) | |
| 1/17/2025 | 61XBL21DOXYLAMINE SUCCINATE (ANTI-HISTAMINIC) | Division of Northern Border Imports (DNBI) | |
| 1/17/2025 | 61XBL21DOXYLAMINE SUCCINATE (ANTI-HISTAMINIC) | Division of Northern Border Imports (DNBI) | |
| 1/17/2025 | 61XBL21DOXYLAMINE SUCCINATE (ANTI-HISTAMINIC) | Division of Northern Border Imports (DNBI) | |
| 1/17/2025 | 61XBL21DOXYLAMINE SUCCINATE (ANTI-HISTAMINIC) | Division of Northern Border Imports (DNBI) | |
| 1/17/2025 | 61XBL21DOXYLAMINE SUCCINATE (ANTI-HISTAMINIC) | Division of Northern Border Imports (DNBI) | |
| 1/17/2025 | 61XBL21DOXYLAMINE SUCCINATE (ANTI-HISTAMINIC) | Division of Northern Border Imports (DNBI) | |
| 1/17/2025 | 61XBL21DOXYLAMINE SUCCINATE (ANTI-HISTAMINIC) | Division of Northern Border Imports (DNBI) | |
| 1/17/2025 | 61XBL21DOXYLAMINE SUCCINATE (ANTI-HISTAMINIC) | Division of Northern Border Imports (DNBI) | |
| 1/17/2025 | 61XBL21DOXYLAMINE SUCCINATE (ANTI-HISTAMINIC) | Division of Northern Border Imports (DNBI) | |
| 1/17/2025 | 61XBL21DOXYLAMINE SUCCINATE (ANTI-HISTAMINIC) | Division of Northern Border Imports (DNBI) | |
| 1/17/2025 | 61XBL21DOXYLAMINE SUCCINATE (ANTI-HISTAMINIC) | Division of Northern Border Imports (DNBI) | |
| 1/17/2025 | 61XBL21DOXYLAMINE SUCCINATE (ANTI-HISTAMINIC) | Division of Northern Border Imports (DNBI) | |
| 1/17/2025 | 61XBL21DOXYLAMINE SUCCINATE (ANTI-HISTAMINIC) | Division of Northern Border Imports (DNBI) | |
| 1/17/2025 | 61XBL21DOXYLAMINE SUCCINATE (ANTI-HISTAMINIC) | Division of Northern Border Imports (DNBI) | |
| 1/17/2025 | 61XBL21DOXYLAMINE SUCCINATE (ANTI-HISTAMINIC) | Division of Northern Border Imports (DNBI) | |
| 1/17/2025 | 61XBL21DOXYLAMINE SUCCINATE (ANTI-HISTAMINIC) | Division of Northern Border Imports (DNBI) | |
| 1/17/2025 | 61XBL21DOXYLAMINE SUCCINATE (ANTI-HISTAMINIC) | Division of Northern Border Imports (DNBI) | |
| 1/17/2025 | 61XBL21DOXYLAMINE SUCCINATE (ANTI-HISTAMINIC) | Division of Northern Border Imports (DNBI) | |
| 1/17/2025 | 61XBL21DOXYLAMINE SUCCINATE (ANTI-HISTAMINIC) | Division of Northern Border Imports (DNBI) | |
| 1/17/2025 | 61XBL21DOXYLAMINE SUCCINATE (ANTI-HISTAMINIC) | Division of Northern Border Imports (DNBI) | |
| 1/17/2025 | 61XBL21DOXYLAMINE SUCCINATE (ANTI-HISTAMINIC) | Division of Northern Border Imports (DNBI) | |
| 1/17/2025 | 61XBL21DOXYLAMINE SUCCINATE (ANTI-HISTAMINIC) | Division of Northern Border Imports (DNBI) | |
| 12/10/2024 | 61XBL21DOXYLAMINE SUCCINATE (ANTI-HISTAMINIC) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 12/10/2024 | 61XBL21DOXYLAMINE SUCCINATE (ANTI-HISTAMINIC) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 12/10/2024 | 61XBL21DOXYLAMINE SUCCINATE (ANTI-HISTAMINIC) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is Lelypharma BV's FDA import refusal history?
Lelypharma BV (FEI: 3015660451) has 32 FDA import refusal record(s) in our database, spanning from 12/10/2024 to 1/17/2025.
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. Lelypharma BV's FEI number is 3015660451.
What types of violations has Lelypharma BV received?
Lelypharma 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 Lelypharma BV come from?
All FDA import refusal data for Lelypharma 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.