Nova Nordisk
⚠️ High Risk
FEI: 1000651745 • Mississauga, ON • CANADA
FEI Number
1000651745
Location
Mississauga, ON
Country
CANADAAddress
2700 Matheson Blvd E 3rd Floor, , Mississauga, 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).
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
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 |
|---|---|---|---|
| 5/28/2025 | 61PCL72SEMAGLUTIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/12/2025 | 61PCL72SEMAGLUTIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/26/2024 | 61PCL72SEMAGLUTIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/1/2023 | 61PCY17INSULIN (INJ) (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/28/2015 | 61PCK17INSULIN (INJ) (ANTI-DIABETIC) | 3280FRNMFGREG | Los Angeles District Office (LOS-DO) |
| 7/28/2015 | 80KZHINTRODUCER, SYRINGE NEEDLE | 237NO PMA | Los Angeles District Office (LOS-DO) |
| 9/3/2009 | 64GCA07ESTRADIOL (ESTROGEN) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 9/5/2007 | 61PCY17INSULIN (INJ) (ANTI-DIABETIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 11/19/2004 | 61PCA28TOLAZAMIDE (ANTI-DIABETIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Nova Nordisk's FDA import refusal history?
Nova Nordisk (FEI: 1000651745) has 9 FDA import refusal record(s) in our database, spanning from 11/19/2004 to 5/28/2025.
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. Nova Nordisk's FEI number is 1000651745.
What types of violations has Nova Nordisk received?
Nova 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 Nova Nordisk come from?
All FDA import refusal data for Nova 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.