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Virion Serion

⚠️ Moderate Risk

FEI: 3004646615 • Wurzburg, Bavaria • GERMANY

FEI

FEI Number

3004646615

📍

Location

Wurzburg, Bavaria

🇩🇪

Country

GERMANY
🏢

Address

Friedrich-Bergius-Ring 19, , Wurzburg, Bavaria, Germany

Moderate Risk

FDA Import Risk Assessment

31.8
LowModerateHighCritical

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

Statistics

4
Total Refusals
1
Unique Violations
9/9/2011
Latest Refusal
9/9/2011
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
25.9×30%
Recency
0.0×20%
Frequency
40.0×10%
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

1184×

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
9/9/2011
88LDTREAGENT, GENERAL PURPOSE
118NOT LISTED
New Orleans District Office (NOL-DO)
9/9/2011
83MYFENZYME LINKED IMMUNOSORBENT ASSAY HERPES SIMPLEX VIRUS, HSV-2
118NOT LISTED
New Orleans District Office (NOL-DO)
9/9/2011
83LHKANTIGEN, ID, CANDIDA ALBICANS
118NOT LISTED
New Orleans District Office (NOL-DO)
9/9/2011
83JWTANTIGEN, CF, ASPERGILLUS SPP.
118NOT LISTED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Virion Serion's FDA import refusal history?

Virion Serion (FEI: 3004646615) has 4 FDA import refusal record(s) in our database, spanning from 9/9/2011 to 9/9/2011.

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. Virion Serion's FEI number is 3004646615.

What types of violations has Virion Serion received?

Virion Serion 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 Virion Serion come from?

All FDA import refusal data for Virion Serion 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.