Novartis Pharma AG
⚠️ High Risk
FEI: 3009487425 • Basel, Basel Stadt • SWITZERLAND
FEI Number
3009487425
Location
Basel, Basel Stadt
Country
SWITZERLANDAddress
Form 1, , Basel, Basel Stadt, Switzerland
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/24/2025 | 62ODA12VALSARTAN (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/18/2024 | 61PDY26METFORMIN (ANTI-DIABETIC) | Division of Southeast Imports (DSEI) | |
| 11/9/2021 | 61LCA99ANTI-COAGULANT, N.E.C. | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 11/9/2021 | 62GCA99ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 6/2/2020 | 62ODY14AMLODIPINE BESYLATE (ANTI-HYPERTENSIVE, PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Novartis Pharma AG's FDA import refusal history?
Novartis Pharma AG (FEI: 3009487425) has 5 FDA import refusal record(s) in our database, spanning from 6/2/2020 to 7/24/2025.
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. Novartis Pharma AG's FEI number is 3009487425.
What types of violations has Novartis Pharma AG received?
Novartis Pharma AG 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 Novartis Pharma AG come from?
All FDA import refusal data for Novartis Pharma AG 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.