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XOVIS AG

⚠️ Moderate Risk

FEI: 3013255038 • Zollikofen, Bern • SWITZERLAND

FEI

FEI Number

3013255038

📍

Location

Zollikofen, Bern

🇨🇭
🏢

Address

Industriestrasse 1, , Zollikofen, Bern, Switzerland

Moderate Risk

FDA Import Risk Assessment

32.2
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
9/8/2022
Latest Refusal
9/8/2022
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
Refusal Volume
11.2×30%
Recency
19.1×20%
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

4761×

NO REGISTR

The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).

Refusal History

DateProductViolationsDivision
9/8/2022
95RHZ3D LASER SCANNING SYSTEM
476NO REGISTR
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is XOVIS AG's FDA import refusal history?

XOVIS AG (FEI: 3013255038) has 1 FDA import refusal record(s) in our database, spanning from 9/8/2022 to 9/8/2022.

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. XOVIS AG's FEI number is 3013255038.

What types of violations has XOVIS AG received?

XOVIS 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 XOVIS AG come from?

All FDA import refusal data for XOVIS 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.