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Mp Biomedicals Suisse Sa

✅ Low Risk

FEI: 3005440902 • Geneva 1, Geneva • SWITZERLAND

FEI

FEI Number

3005440902

📍

Location

Geneva 1, Geneva

🇨🇭
🏢

Address

Banque 2, , Geneva 1, Geneva, Switzerland

Low Risk

FDA Import Risk Assessment

22.9
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

2
Total Refusals
2
Unique Violations
3/16/2007
Latest Refusal
12/5/2005
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
15.7×10%
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

1181×

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).

3411×

REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

Refusal History

DateProductViolationsDivision
3/16/2007
81NPRTEST, FACTOR II G20210A MUTATIONS, GENOMIC DNA PCR
118NOT LISTED
Florida District Office (FLA-DO)
12/5/2005
80LDQDEVICE, GENERAL MEDICAL
341REGISTERED
Florida District Office (FLA-DO)

Frequently Asked Questions

What is Mp Biomedicals Suisse Sa's FDA import refusal history?

Mp Biomedicals Suisse Sa (FEI: 3005440902) has 2 FDA import refusal record(s) in our database, spanning from 12/5/2005 to 3/16/2007.

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. Mp Biomedicals Suisse Sa's FEI number is 3005440902.

What types of violations has Mp Biomedicals Suisse Sa received?

Mp Biomedicals Suisse Sa 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 Mp Biomedicals Suisse Sa come from?

All FDA import refusal data for Mp Biomedicals Suisse Sa 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.