Eli Lilly Canada Inc.
⚠️ High Risk
FEI: 3002807500 • Scarborough, ON • CANADA
FEI Number
3002807500
Location
Scarborough, ON
Country
CANADAAddress
3650 Danforth Ave, , Scarborough, 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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
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 |
|---|---|---|---|
| 12/18/2025 | 61PDY20PROTAMINE ZINC INSULIN (SUSP) (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/12/2025 | 61PCL74TIRZEPATIDE (ANTI-DIABETIC) | Division of Southeast Imports (DSEI) | |
| 3/22/2019 | 61PDL58INSULIN LISPRO PROTAMINE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/8/2017 | 61PCY17INSULIN (INJ) (ANTI-DIABETIC) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 4/5/2017 | 65PCY02SILDENAFIL CITRATE (REGULATOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/5/2017 | 65PCY02SILDENAFIL CITRATE (REGULATOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/5/2017 | 66SCY51TADALAFIL | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/5/2017 | 66SCY51TADALAFIL | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/10/2015 | 66SCY51TADALAFIL | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/22/2014 | 61PAY17INSULIN (INJ) (ANTI-DIABETIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 8/28/2009 | 64RCP21SOMATROPIN (HORMONE) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/24/2009 | 66NAA02OLANZAPINE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 9/25/2008 | 66SCA51TADALAFIL | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 8/15/2007 | 63ACA06RALOXIFENE HCL (BONE CALCIUM REGULATOR) | Detroit District Office (DET-DO) | |
| 10/31/2006 | 61PLY17INSULIN (INJ) (ANTI-DIABETIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 7/25/2006 | 61PJK32INSULIN BIOSYN HUMAN/INSUL SUSP ISOPHANE (ANTI-DIABETIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 9/13/2005 | 63ABC06RALOXIFENE HCL (BONE CALCIUM REGULATOR) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 11/19/2004 | 61PAK17INSULIN (INJ) (ANTI-DIABETIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 11/19/2004 | 61PCA28TOLAZAMIDE (ANTI-DIABETIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/8/2004 | 61PCP17INSULIN (INJ) (ANTI-DIABETIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 7/3/2003 | 61PLP17INSULIN (INJ) (ANTI-DIABETIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/26/2002 | 61PBK38INSULIN SUSP ISOPHANE BIOSYNTHETIC HUMAN (ANTI-DIABETIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Eli Lilly Canada Inc.'s FDA import refusal history?
Eli Lilly Canada Inc. (FEI: 3002807500) has 22 FDA import refusal record(s) in our database, spanning from 8/26/2002 to 12/18/2025.
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 3002807500.
What types of violations has Eli Lilly Canada Inc. received?
Eli Lilly Canada Inc. has been cited for 6 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.