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SCHOTT FORMA VITRUM EUROPE AG

✅ Low Risk

FEI: 3012487715 • St. Gallen, St. Gallen • SWITZERLAND

FEI

FEI Number

3012487715

📍

Location

St. Gallen, St. Gallen

🇨🇭
🏢

Address

St. Josefen-Strasse 20, , St. Gallen, St. Gallen, Switzerland

Low Risk

FDA Import Risk Assessment

24.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
3/26/2019
Latest Refusal
3/26/2019
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
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

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).

Refusal History

DateProductViolationsDivision
3/26/2019
78FIHPUMP, INFUSION OR SYRINGE, EXTRA-LUMINAL
118NOT LISTED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is SCHOTT FORMA VITRUM EUROPE AG's FDA import refusal history?

SCHOTT FORMA VITRUM EUROPE AG (FEI: 3012487715) has 1 FDA import refusal record(s) in our database, spanning from 3/26/2019 to 3/26/2019.

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. SCHOTT FORMA VITRUM EUROPE AG's FEI number is 3012487715.

What types of violations has SCHOTT FORMA VITRUM EUROPE AG received?

SCHOTT FORMA VITRUM EUROPE 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 SCHOTT FORMA VITRUM EUROPE AG come from?

All FDA import refusal data for SCHOTT FORMA VITRUM EUROPE 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.