ELI LILLY
⚠️ High Risk
FEI: 3012419517 • Basingstoke, Hampshire • UNITED KINGDOM
FEI Number
3012419517
Location
Basingstoke, Hampshire
Country
UNITED KINGDOMAddress
Lilly House, Priestley Road, Basingstoke, Hampshire, United Kingdom
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).
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 |
|---|---|---|---|
| 7/14/2025 | 61PCY74TIRZEPATIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/29/2025 | 80FMINEEDLE, HYPODERMIC, SINGLE LUMEN | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 5/29/2025 | 61PAY74TIRZEPATIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/19/2021 | 61PDL17INSULIN (INJ) (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/19/2021 | 61PDL17INSULIN (INJ) (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/25/2018 | 60ZOL99ANTIPARASITIC, N.E.C. | 72NEW VET DR | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is ELI LILLY's FDA import refusal history?
ELI LILLY (FEI: 3012419517) has 6 FDA import refusal record(s) in our database, spanning from 10/25/2018 to 7/14/2025.
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's FEI number is 3012419517.
What types of violations has ELI LILLY received?
ELI LILLY 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 ELI LILLY come from?
All FDA import refusal data for ELI LILLY 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.