ELI LILLY CANADA
⚠️ High Risk
FEI: 3015973880 • Toronto, ON • CANADA
FEI Number
3015973880
Location
Toronto, ON
Country
CANADAAddress
Exchange Tower, Suite 9, , Toronto, ON, Canada
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).
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/19/2025 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 12/19/2025 | 58HDY09INSULIN GLARGINE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/19/2025 | 61PCY74TIRZEPATIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/17/2025 | 61PCY74TIRZEPATIDE (ANTI-DIABETIC) | Division of Southeast Imports (DSEI) | |
| 12/8/2025 | 61PCY74TIRZEPATIDE (ANTI-DIABETIC) | Division of Southeast Imports (DSEI) | |
| 11/25/2025 | 61PCK74TIRZEPATIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/25/2025 | 61PCY74TIRZEPATIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/24/2025 | 61PDY74TIRZEPATIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/16/2025 | 61PCL74TIRZEPATIDE (ANTI-DIABETIC) | Division of Southeast Imports (DSEI) | |
| 1/16/2025 | 61PCY74TIRZEPATIDE (ANTI-DIABETIC) | Division of Southeast Imports (DSEI) | |
| 1/8/2025 | 61PCP74TIRZEPATIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/3/2025 | 61PCK99ANTI-DIABETIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/30/2024 | 61PCL74TIRZEPATIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/30/2024 | 61PCY74TIRZEPATIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/30/2024 | 61PCY74TIRZEPATIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/30/2024 | 61PCY74TIRZEPATIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/30/2024 | 61PDY74TIRZEPATIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/21/2024 | 61PCL74TIRZEPATIDE (ANTI-DIABETIC) | Division of Southeast Imports (DSEI) | |
| 5/9/2024 | 61PCK17INSULIN (INJ) (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/16/2021 | 61PCY17INSULIN (INJ) (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/26/2021 | 61NDA67FLUVOXAMINE MALEATE (ANTI-DEPRESSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/22/2021 | 61PDB99ANTI-DIABETIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is ELI LILLY CANADA's FDA import refusal history?
ELI LILLY CANADA (FEI: 3015973880) has 22 FDA import refusal record(s) in our database, spanning from 9/22/2021 to 12/19/2025.
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's FEI number is 3015973880.
What types of violations has ELI LILLY CANADA received?
ELI LILLY CANADA 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 come from?
All FDA import refusal data for ELI LILLY CANADA 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.