ELI LILLY AND COMPANY LIMITED
⚠️ High Risk
FEI: 3031387466 • Twickenham, RIC • UNITED KINGDOM
FEI Number
3031387466
Location
Twickenham, RIC
Country
UNITED KINGDOMAddress
41 Newry Road, , Twickenham, RIC, 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).
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 |
|---|---|---|---|
| 6/20/2025 | 61PDY74TIRZEPATIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/30/2025 | 61PDY74TIRZEPATIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/28/2025 | 61PDY74TIRZEPATIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/16/2025 | 61PCY74TIRZEPATIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/11/2025 | 61PCL74TIRZEPATIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/8/2025 | 61PDL74TIRZEPATIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/1/2025 | 61PDY74TIRZEPATIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/21/2025 | 61PCY74TIRZEPATIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/21/2025 | 61PCY74TIRZEPATIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/21/2025 | 61PCY74TIRZEPATIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/3/2025 | 61PDL74TIRZEPATIDE (ANTI-DIABETIC) | 118NOT LISTED | Division of West Coast Imports (DWCI) |
| 2/5/2025 | 61PDL74TIRZEPATIDE (ANTI-DIABETIC) | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is ELI LILLY AND COMPANY LIMITED's FDA import refusal history?
ELI LILLY AND COMPANY LIMITED (FEI: 3031387466) has 12 FDA import refusal record(s) in our database, spanning from 2/5/2025 to 6/20/2025.
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 AND COMPANY LIMITED's FEI number is 3031387466.
What types of violations has ELI LILLY AND COMPANY LIMITED received?
ELI LILLY AND COMPANY LIMITED 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 AND COMPANY LIMITED come from?
All FDA import refusal data for ELI LILLY AND COMPANY LIMITED 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.