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Optotech Ag

⚠️ Moderate Risk

FEI: 3011968666 • Bellach, Solothurn • SWITZERLAND

FEI

FEI Number

3011968666

📍

Location

Bellach, Solothurn

🇨🇭
🏢

Address

Dorfstrasse 37, , Bellach, Solothurn, Switzerland

Moderate Risk

FDA Import Risk Assessment

28.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
12/20/2018
Latest Refusal
12/20/2018
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
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

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
12/20/2018
95RHKLASER MARKER OR ENGRAVER
476NO REGISTR
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Optotech Ag's FDA import refusal history?

Optotech Ag (FEI: 3011968666) has 1 FDA import refusal record(s) in our database, spanning from 12/20/2018 to 12/20/2018.

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. Optotech Ag's FEI number is 3011968666.

What types of violations has Optotech Ag received?

Optotech 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 Optotech Ag come from?

All FDA import refusal data for Optotech 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.