Novo Nordisk Pharma Ltd
⚠️ High Risk
FEI: 3007427915 • Chiyoda, Tokyo • JAPAN
FEI Number
3007427915
Location
Chiyoda, Tokyo
Country
JAPANAddress
2 Chome 1-1, Marunochi, Chiyoda, Tokyo, Japan
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
Frequently Asked Questions
What is Novo Nordisk Pharma Ltd's FDA import refusal history?
Novo Nordisk Pharma Ltd (FEI: 3007427915) has 2 FDA import refusal record(s) in our database, spanning from 12/11/2023 to 5/5/2025.
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 Pharma Ltd's FEI number is 3007427915.
What types of violations has Novo Nordisk Pharma Ltd received?
Novo Nordisk Pharma Ltd 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 Pharma Ltd come from?
All FDA import refusal data for Novo Nordisk Pharma Ltd 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.