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Ingenus Pharmaceuticals GmbH

⚠️ Moderate Risk

FEI: 3005403232 • Barbengo, Ticino • SWITZERLAND

FEI

FEI Number

3005403232

📍

Location

Barbengo, Ticino

🇨🇭
🏢

Address

Via Cadepiano 24, , Barbengo, Ticino, Switzerland

Moderate Risk

FDA Import Risk Assessment

43.5
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

2
Total Refusals
1
Unique Violations
10/14/2025
Latest Refusal
10/14/2025
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
17.7×30%
Recency
80.9×20%
Frequency
20.0×10%
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

1182×

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

DateProductViolationsDivision
10/14/2025
62ZCK01CARBOPLATIN (ANTI-NEOPLASTIC - PART II)
118NOT LISTED
Division of Northern Border Imports (DNBI)
10/14/2025
62ZCK01CARBOPLATIN (ANTI-NEOPLASTIC - PART II)
118NOT LISTED
Division of Northern Border Imports (DNBI)

Frequently Asked Questions

What is Ingenus Pharmaceuticals GmbH's FDA import refusal history?

Ingenus Pharmaceuticals GmbH (FEI: 3005403232) has 2 FDA import refusal record(s) in our database, spanning from 10/14/2025 to 10/14/2025.

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. Ingenus Pharmaceuticals GmbH's FEI number is 3005403232.

What types of violations has Ingenus Pharmaceuticals GmbH received?

Ingenus Pharmaceuticals GmbH 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 Ingenus Pharmaceuticals GmbH come from?

All FDA import refusal data for Ingenus Pharmaceuticals GmbH 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.