Novo Nordisk A/S
⚠️ High Risk
FEI: 3002807751 • Kalundborg, Sjalland • DENMARK
FEI Number
3002807751
Location
Kalundborg, Sjalland
Country
DENMARKAddress
Hallas Alle 1, , Kalundborg, Sjalland, Denmark
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 ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/22/2026 | 58HCY07INSULIN DEGLUDEC | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/6/2026 | 61PDY72SEMAGLUTIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/16/2025 | 61PDY72SEMAGLUTIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/3/2025 | 61PDB55METFORMIN HCL (ANTI-DIABETIC) | Division of Southeast Imports (DSEI) | |
| 5/19/2024 | 61PCY72SEMAGLUTIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/6/2023 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Novo Nordisk A/S's FDA import refusal history?
Novo Nordisk A/S (FEI: 3002807751) has 6 FDA import refusal record(s) in our database, spanning from 10/6/2023 to 1/22/2026.
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 A/S's FEI number is 3002807751.
What types of violations has Novo Nordisk A/S received?
Novo Nordisk A/S has been cited for 2 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 A/S come from?
All FDA import refusal data for Novo Nordisk A/S 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.