ELI LILLY NEDERLAND B.V.
⚠️ High Risk
FEI: 3013185023 • Utrecht, Utrecht • NETHERLANDS
FEI Number
3013185023
Location
Utrecht, Utrecht
Country
NETHERLANDSAddress
Papendorpseweg 83, , Utrecht, Utrecht, 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).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/20/2025 | 58HCY06DULAGLUTIDE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/1/2025 | 61PCY74TIRZEPATIDE (ANTI-DIABETIC) | Division of Northeast Imports (DNEI) | |
| 1/31/2025 | 61PDY74TIRZEPATIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/14/2024 | 61PCY99ANTI-DIABETIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/24/2024 | 61PDY74TIRZEPATIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/3/2024 | 61PCK74TIRZEPATIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/7/2024 | 61PCY74TIRZEPATIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/6/2023 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/4/2023 | 61PDY10GLUCAGON (ANTI-DIABETIC) | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is ELI LILLY NEDERLAND B.V.'s FDA import refusal history?
ELI LILLY NEDERLAND B.V. (FEI: 3013185023) has 9 FDA import refusal record(s) in our database, spanning from 1/4/2023 to 10/20/2025.
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. ELI LILLY NEDERLAND B.V.'s FEI number is 3013185023.
What types of violations has ELI LILLY NEDERLAND B.V. received?
ELI LILLY NEDERLAND B.V. has been cited for 5 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 ELI LILLY NEDERLAND B.V. come from?
All FDA import refusal data for ELI LILLY NEDERLAND 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.