ELI LILLY CANADA INC
🚨 Critical Risk
FEI: 3016932120 • Toronto, ON • CANADA
FEI Number
3016932120
Location
Toronto, ON
Country
CANADAAddress
Exchange Tower, 130 Kin, , Toronto, ON, Canada
Critical Risk
FDA Import Risk Assessment
This firm has an extensive history of FDA import refusals with severe 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 |
|---|---|---|---|
| 12/29/2025 | 61PCK17INSULIN (INJ) (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/10/2025 | 61PIY74TIRZEPATIDE (ANTI-DIABETIC) | Division of Southeast Imports (DSEI) | |
| 12/9/2025 | 61PCY74TIRZEPATIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/5/2025 | 61PCY74TIRZEPATIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/10/2025 | 61PDL74TIRZEPATIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/21/2025 | 61PCY74TIRZEPATIDE (ANTI-DIABETIC) | Division of Southeast Imports (DSEI) | |
| 3/4/2025 | 58MCP11IXEKIZUMAB | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/4/2025 | 58MCP11IXEKIZUMAB | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/4/2025 | 58MCP11IXEKIZUMAB | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/21/2025 | 61PCL74TIRZEPATIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/13/2025 | 58MDY11IXEKIZUMAB | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/8/2025 | 61PCL74TIRZEPATIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/27/2024 | 61PCY74TIRZEPATIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/27/2024 | 58MCY11IXEKIZUMAB | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/7/2024 | 66VIY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/4/2024 | 58MDY11IXEKIZUMAB | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/12/2024 | 60IDY02TROMETHAMINE (ALKALIZER) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/20/2023 | 61PCY99ANTI-DIABETIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is ELI LILLY CANADA INC's FDA import refusal history?
ELI LILLY CANADA INC (FEI: 3016932120) has 18 FDA import refusal record(s) in our database, spanning from 9/20/2023 to 12/29/2025.
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 CANADA INC's FEI number is 3016932120.
What types of violations has ELI LILLY CANADA INC received?
ELI LILLY CANADA INC 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 CANADA INC come from?
All FDA import refusal data for ELI LILLY CANADA INC 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.