Delpharm Meppel B.V.
⚠️ High Risk
FEI: 3002808518 • Meppel, Drenthe • NETHERLANDS
FEI Number
3002808518
Location
Meppel, Drenthe
Country
NETHERLANDSAddress
Hogemaat 2, , Meppel, Drenthe, 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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
Refusal History
Frequently Asked Questions
What is Delpharm Meppel B.V.'s FDA import refusal history?
Delpharm Meppel B.V. (FEI: 3002808518) has 3 FDA import refusal record(s) in our database, spanning from 6/28/2011 to 9/3/2025.
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. Delpharm Meppel B.V.'s FEI number is 3002808518.
What types of violations has Delpharm Meppel B.V. received?
Delpharm Meppel B.V. 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 Delpharm Meppel B.V. come from?
All FDA import refusal data for Delpharm Meppel B.V. 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.