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Novartis Pharma Schweiz Ag

⚠️ High Risk

FEI: 3010085804 • Rotkreuz • NETHERLANDS

FEI

FEI Number

3010085804

📍

Location

Rotkreuz

🇳🇱
🏢

Address

Suurstoffi 14, , Rotkreuz, , Netherlands

High Risk

FDA Import Risk Assessment

52.5
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

4
Total Refusals
2
Unique Violations
10/3/2023
Latest Refusal
11/4/2014
Earliest Refusal

Score Breakdown

Violation Severity
83.3×40%
Refusal Volume
25.9×30%
Recency
54.5×20%
Frequency
4.5×10%
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

754×

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).

3422×

PERSONALRX

The article appears to be a drug which requires a prescription from your doctor.

Refusal History

DateProductViolationsDivision
10/3/2023
62ODA14AMLODIPINE BESYLATE (ANTI-HYPERTENSIVE, PART II)
75UNAPPROVED
Division of Southeast Imports (DSEI)
10/3/2023
61PDA26METFORMIN (ANTI-DIABETIC)
75UNAPPROVED
Division of Southeast Imports (DSEI)
11/4/2014
64UCH99INHIBITOR N.E.C.
342PERSONALRX
75UNAPPROVED
New York District Office (NYK-DO)
11/4/2014
62GCL18DICLOFENAC SODIUM (ANTI-INFLAMMATORY)
342PERSONALRX
75UNAPPROVED
New York District Office (NYK-DO)

Frequently Asked Questions

What is Novartis Pharma Schweiz Ag's FDA import refusal history?

Novartis Pharma Schweiz Ag (FEI: 3010085804) has 4 FDA import refusal record(s) in our database, spanning from 11/4/2014 to 10/3/2023.

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 Schweiz Ag's FEI number is 3010085804.

What types of violations has Novartis Pharma Schweiz Ag received?

Novartis Pharma Schweiz 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 Schweiz Ag come from?

All FDA import refusal data for Novartis Pharma Schweiz 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.