ImportRefusal LogoImportRefusal

Omega Laser Sylstmes Limited

⚠️ Moderate Risk

FEI: 3003085250 • West Sussex • UNITED KINGDOM

FEI

FEI Number

3003085250

📍

Location

West Sussex

🇬🇧
🏢

Address

6 Raliegh Court, , West Sussex, , United Kingdom

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
1/29/2002
Latest Refusal
1/29/2002
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
1/29/2002
84LLPLASER FOR PAIN THERAPY
476NO REGISTR
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Omega Laser Sylstmes Limited's FDA import refusal history?

Omega Laser Sylstmes Limited (FEI: 3003085250) has 1 FDA import refusal record(s) in our database, spanning from 1/29/2002 to 1/29/2002.

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. Omega Laser Sylstmes Limited's FEI number is 3003085250.

What types of violations has Omega Laser Sylstmes Limited received?

Omega Laser Sylstmes Limited 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 Omega Laser Sylstmes Limited come from?

All FDA import refusal data for Omega Laser Sylstmes Limited 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.