NOVO NORDISK
🚨 Critical Risk
FEI: 3014158939 • Mississauga, Ontario • CANADA
FEI
FEI Number
3014158939
📍
Location
Mississauga, Ontario
🇨🇦
Country
CANADA🏢
Address
101-2476 Argentia Rd, , Mississauga, Ontario, Canada
Critical Risk
FDA Import Risk Assessment
89.2
LowModerateHighCritical
This firm has an extensive history of FDA import refusals with severe violations.
Statistics
193
Total Refusals
3
Unique Violations
12/22/2025
Latest Refusal
1/29/2019
Earliest Refusal
Score Breakdown
Violation Severity
85.0×40%
Refusal Volume
84.7×30%
Recency
99.0×20%
Frequency
100.0×10%
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
75191×
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).
11824×
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).
32803×
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 |
|---|---|---|---|
| 12/22/2025 | 61PCL72SEMAGLUTIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/22/2025 | 61PCP72SEMAGLUTIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/22/2025 | 61PCL72SEMAGLUTIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/22/2025 | 61PCY99ANTI-DIABETIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/19/2025 | 61PDY72SEMAGLUTIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/19/2025 | 61PCA72SEMAGLUTIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/18/2025 | 61PDC72SEMAGLUTIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/14/2025 | 61PCY72SEMAGLUTIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/14/2025 | 61PDY72SEMAGLUTIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/14/2025 | 61PCP72SEMAGLUTIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/12/2025 | 61PCY72SEMAGLUTIDE (ANTI-DIABETIC) | Division of Southeast Imports (DSEI) | |
| 12/9/2025 | 61PCY72SEMAGLUTIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/9/2025 | 61PCY72SEMAGLUTIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/9/2025 | 61PCY72SEMAGLUTIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/5/2025 | 61PCY72SEMAGLUTIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/5/2025 | 61PCY72SEMAGLUTIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/5/2025 | 61PCY72SEMAGLUTIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/5/2025 | 61PCY72SEMAGLUTIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/1/2025 | 61PCK72SEMAGLUTIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/1/2025 | 58HDL07INSULIN DEGLUDEC | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/25/2025 | 61PDK17INSULIN (INJ) (ANTI-DIABETIC) | Division of Southeast Imports (DSEI) | |
| 11/17/2025 | 61PDY72SEMAGLUTIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/13/2025 | 61PCP72SEMAGLUTIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/10/2025 | 61PDY72SEMAGLUTIDE (ANTI-DIABETIC) | Division of Southeast Imports (DSEI) | |
| 11/10/2025 | 61PCY72SEMAGLUTIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/20/2025 | 61PCY72SEMAGLUTIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/10/2025 | 61PCY72SEMAGLUTIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/28/2025 | 61PCY72SEMAGLUTIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/19/2025 | 61PDK72SEMAGLUTIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/4/2025 | 61PCY72SEMAGLUTIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/27/2025 | 61PDL72SEMAGLUTIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/13/2025 | 61PDY72SEMAGLUTIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/6/2025 | 61PCY72SEMAGLUTIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/31/2025 | 61PCL72SEMAGLUTIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/29/2025 | 61PCP99ANTI-DIABETIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/24/2025 | 61PCY72SEMAGLUTIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/24/2025 | 61PCP99ANTI-DIABETIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/24/2025 | 61PCL72SEMAGLUTIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/24/2025 | 61PCL72SEMAGLUTIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/23/2025 | 61PCP99ANTI-DIABETIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/23/2025 | 61PCP99ANTI-DIABETIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/23/2025 | 61PCP99ANTI-DIABETIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/23/2025 | 61PCP72SEMAGLUTIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/23/2025 | 61PCP99ANTI-DIABETIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/22/2025 | 61PCK72SEMAGLUTIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/21/2025 | 61PCY72SEMAGLUTIDE (ANTI-DIABETIC) | Division of Southeast Imports (DSEI) | |
| 1/21/2025 | 61PCY72SEMAGLUTIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/21/2025 | 61PDY72SEMAGLUTIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/21/2025 | 61PCY72SEMAGLUTIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/21/2025 | 61PCK72SEMAGLUTIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/21/2025 | 61PCY72SEMAGLUTIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/21/2025 | 61PCY72SEMAGLUTIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/21/2025 | 61PCL72SEMAGLUTIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/21/2025 | 61PDK74TIRZEPATIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/21/2025 | 61PCK72SEMAGLUTIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/21/2025 | 61PCL72SEMAGLUTIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/21/2025 | 61PCY72SEMAGLUTIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/16/2025 | 61PDY99ANTI-DIABETIC N.E.C. | Division of Southeast Imports (DSEI) | |
| 1/16/2025 | 61PCL72SEMAGLUTIDE (ANTI-DIABETIC) | Division of Southeast Imports (DSEI) | |
| 1/16/2025 | 61PCP72SEMAGLUTIDE (ANTI-DIABETIC) | Division of Southeast Imports (DSEI) | |
| 1/14/2025 | 61PCY72SEMAGLUTIDE (ANTI-DIABETIC) | Division of Southeast Imports (DSEI) | |
| 1/14/2025 | 61PCY72SEMAGLUTIDE (ANTI-DIABETIC) | Division of Southeast Imports (DSEI) | |
| 1/14/2025 | 61PCK72SEMAGLUTIDE (ANTI-DIABETIC) | Division of Southeast Imports (DSEI) | |
| 1/13/2025 | 61PCY72SEMAGLUTIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 1/13/2025 | 61PCY72SEMAGLUTIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 1/8/2025 | 61PCP99ANTI-DIABETIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/8/2025 | 61PCK72SEMAGLUTIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/8/2025 | 61PCY72SEMAGLUTIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/8/2025 | 61PCY72SEMAGLUTIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/8/2025 | 61PCP72SEMAGLUTIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/8/2025 | 61PDL72SEMAGLUTIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/8/2025 | 61PCY72SEMAGLUTIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/8/2025 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/8/2025 | 61PCP99ANTI-DIABETIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/8/2025 | 61PCY72SEMAGLUTIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/8/2025 | 61PCP72SEMAGLUTIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/8/2025 | 61PCY72SEMAGLUTIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/8/2025 | 61PCP72SEMAGLUTIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/6/2025 | 61PCY72SEMAGLUTIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/6/2025 | 61PDL72SEMAGLUTIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/3/2025 | 61PDY72SEMAGLUTIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/3/2025 | 61PCY72SEMAGLUTIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/3/2025 | 61PCY72SEMAGLUTIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/3/2025 | 61PDL72SEMAGLUTIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/3/2025 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/31/2024 | 61PDL72SEMAGLUTIDE (ANTI-DIABETIC) | Division of Southeast Imports (DSEI) | |
| 12/31/2024 | 61PDY72SEMAGLUTIDE (ANTI-DIABETIC) | Division of Southeast Imports (DSEI) | |
| 12/31/2024 | 61PCY72SEMAGLUTIDE (ANTI-DIABETIC) | Division of Southeast Imports (DSEI) | |
| 12/31/2024 | 61PCY72SEMAGLUTIDE (ANTI-DIABETIC) | Division of Southeast Imports (DSEI) | |
| 12/31/2024 | 61PCY72SEMAGLUTIDE (ANTI-DIABETIC) | Division of Southeast Imports (DSEI) | |
| 12/31/2024 | 61PCY72SEMAGLUTIDE (ANTI-DIABETIC) | Division of Southeast Imports (DSEI) | |
| 12/31/2024 | 61PCY72SEMAGLUTIDE (ANTI-DIABETIC) | Division of Southeast Imports (DSEI) | |
| 12/31/2024 | 61PCL17INSULIN (INJ) (ANTI-DIABETIC) | Division of Southeast Imports (DSEI) | |
| 12/31/2024 | 61PCP72SEMAGLUTIDE (ANTI-DIABETIC) | Division of Southeast Imports (DSEI) | |
| 12/31/2024 | 61PCY72SEMAGLUTIDE (ANTI-DIABETIC) | Division of Southeast Imports (DSEI) | |
| 12/30/2024 | 61PAY72SEMAGLUTIDE (ANTI-DIABETIC) | Division of Southeast Imports (DSEI) | |
| 12/30/2024 | 61PAY72SEMAGLUTIDE (ANTI-DIABETIC) | Division of Southeast Imports (DSEI) | |
| 12/30/2024 | 61PCY72SEMAGLUTIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/30/2024 | 61PCY72SEMAGLUTIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/30/2024 | 61PCY72SEMAGLUTIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is NOVO NORDISK's FDA import refusal history?
NOVO NORDISK (FEI: 3014158939) has 193 FDA import refusal record(s) in our database, spanning from 1/29/2019 to 12/22/2025.
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. NOVO NORDISK's FEI number is 3014158939.
What types of violations has NOVO NORDISK received?
NOVO NORDISK 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 NOVO NORDISK come from?
All FDA import refusal data for NOVO NORDISK 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.