ImportRefusal LogoImportRefusal

Mandaconsult Ag

⚠️ Moderate Risk

FEI: 3005387896 • Zug, Zug • SWITZERLAND

FEI

FEI Number

3005387896

📍

Location

Zug, Zug

🇨🇭
🏢

Address

Industriestrasse 13b, , Zug, Zug, Switzerland

Moderate Risk

FDA Import Risk Assessment

29.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
1
Unique Violations
11/22/2005
Latest Refusal
11/22/2005
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

1183×

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
11/22/2005
65VDA13CLOZAPINE (SEDATIVE)
118NOT LISTED
San Francisco District Office (SAN-DO)
11/22/2005
66NCA04RISPERIDONE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II)
118NOT LISTED
San Francisco District Office (SAN-DO)
11/22/2005
61NCA11CLOMIPRAMINE HCL (ANTI-DEPRESSANT)
118NOT LISTED
San Francisco District Office (SAN-DO)

Frequently Asked Questions

What is Mandaconsult Ag's FDA import refusal history?

Mandaconsult Ag (FEI: 3005387896) has 3 FDA import refusal record(s) in our database, spanning from 11/22/2005 to 11/22/2005.

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. Mandaconsult Ag's FEI number is 3005387896.

What types of violations has Mandaconsult Ag received?

Mandaconsult Ag 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 Mandaconsult Ag come from?

All FDA import refusal data for Mandaconsult 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.