Novo Nordisk A/S - G8, X9 M.FI
⚠️ High Risk
FEI: 3003037054 • Malov, Hovedstaden • DENMARK
FEI Number
3003037054
Location
Malov, Hovedstaden
Country
DENMARKAddress
Novo Nordisk Park 99, , Malov, 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).
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).
AGR RX
The article appears to be a prescription drug manufactured in the U.S. and offered for import by other than the manufacturer and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/1/2025 | 61PDC72SEMAGLUTIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/22/2025 | 61PCA72SEMAGLUTIDE (ANTI-DIABETIC) | 118NOT LISTED | Division of West Coast Imports (DWCI) |
| 5/2/2025 | 61PCY72SEMAGLUTIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/9/2024 | 61PDY72SEMAGLUTIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/6/2024 | 61PDK72SEMAGLUTIDE (ANTI-DIABETIC) | 179AGR RX | Division of Northern Border Imports (DNBI) |
| 6/30/2021 | 61PCK99ANTI-DIABETIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/15/2012 | 66VIP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/22/2012 | 66VIP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Novo Nordisk A/S - G8, X9 M.FI's FDA import refusal history?
Novo Nordisk A/S - G8, X9 M.FI (FEI: 3003037054) has 8 FDA import refusal record(s) in our database, spanning from 2/22/2012 to 12/1/2025.
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 - G8, X9 M.FI's FEI number is 3003037054.
What types of violations has Novo Nordisk A/S - G8, X9 M.FI received?
Novo Nordisk A/S - G8, X9 M.FI 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 A/S - G8, X9 M.FI come from?
All FDA import refusal data for Novo Nordisk A/S - G8, X9 M.FI 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.