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Laserex Technologies Pty Ltd

⚠️ Moderate Risk

FEI: 3010613655 • Adelaide, Sa • AUSTRALIA

FEI

FEI Number

3010613655

📍

Location

Adelaide, Sa

🇦🇺

Country

AUSTRALIA
🏢

Address

136 Sturt St, , Adelaide, Sa, Australia

Moderate Risk

FDA Import Risk Assessment

29.6
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
7/28/2021
Latest Refusal
6/6/2014
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
2.8×10%
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

1261×

FAILS STD

The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.

3361×

INCONSPICU

Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.

Refusal History

DateProductViolationsDivision
7/28/2021
95RGBVETERINARY LASER, IN VITRO AND OTHER MEDICAL LASER PRODUCTS
336INCONSPICU
Division of Southeast Imports (DSEI)
6/6/2014
95RDWGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL
126FAILS STD
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Laserex Technologies Pty Ltd's FDA import refusal history?

Laserex Technologies Pty Ltd (FEI: 3010613655) has 2 FDA import refusal record(s) in our database, spanning from 6/6/2014 to 7/28/2021.

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. Laserex Technologies Pty Ltd's FEI number is 3010613655.

What types of violations has Laserex Technologies Pty Ltd received?

Laserex Technologies Pty Ltd has been cited for 2 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 Laserex Technologies Pty Ltd come from?

All FDA import refusal data for Laserex Technologies Pty Ltd 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.