Novo Nordisk A/S - 25a-B
⚠️ High Risk
FEI: 3003131673 • Hillerod, Hovedstaden • DENMARK
FEI Number
3003131673
Location
Hillerod, Hovedstaden
Country
DENMARKAddress
Bldg. 25a & 25b, Brennum Park, Hillerod, Hovedstaden, 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/5/2025 | 61PCK72SEMAGLUTIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/3/2025 | 61PCY72SEMAGLUTIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 9/3/2025 | 61PCY72SEMAGLUTIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is Novo Nordisk A/S - 25a-B's FDA import refusal history?
Novo Nordisk A/S - 25a-B (FEI: 3003131673) has 3 FDA import refusal record(s) in our database, spanning from 9/3/2025 to 12/5/2025.
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 A/S - 25a-B's FEI number is 3003131673.
What types of violations has Novo Nordisk A/S - 25a-B received?
Novo Nordisk A/S - 25a-B has been cited for 1 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 - 25a-B come from?
All FDA import refusal data for Novo Nordisk A/S - 25a-B 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.