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Signostics Pty Ltd

⚠️ Moderate Risk

FEI: 3007223903 • Thebarton • AUSTRALIA

FEI

FEI Number

3007223903

📍

Location

Thebarton

🇦🇺

Country

AUSTRALIA
🏢

Address

Lot 1, 40-46 West Thebarton Rd, , Thebarton, , Australia

Moderate Risk

FDA Import Risk Assessment

36.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
1/5/2011
Latest Refusal
1/5/2011
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
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

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.

Refusal History

DateProductViolationsDivision
1/5/2011
79NRJULTRASOUND, SKIN PERMEATION
126FAILS STD
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Signostics Pty Ltd's FDA import refusal history?

Signostics Pty Ltd (FEI: 3007223903) has 1 FDA import refusal record(s) in our database, spanning from 1/5/2011 to 1/5/2011.

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. Signostics Pty Ltd's FEI number is 3007223903.

What types of violations has Signostics Pty Ltd received?

Signostics Pty Ltd 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 Signostics Pty Ltd come from?

All FDA import refusal data for Signostics 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.