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Signature Orthopaedics

✅ Low Risk

FEI: 3007196858 • Macquarie Park, New South Wales • AUSTRALIA

FEI

FEI Number

3007196858

📍

Location

Macquarie Park, New South Wales

🇦🇺

Country

AUSTRALIA
🏢

Address

69 Waterloo Rd, 1B, Macquarie Park, New South Wales, Australia

Low Risk

FDA Import Risk Assessment

24.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
1
Unique Violations
12/19/2008
Latest Refusal
12/19/2008
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
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

1181×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

Refusal History

DateProductViolationsDivision
12/19/2008
79MDMINSTRUMENT, MANUAL, GENERAL SURGICAL
118NOT LISTED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Signature Orthopaedics's FDA import refusal history?

Signature Orthopaedics (FEI: 3007196858) has 1 FDA import refusal record(s) in our database, spanning from 12/19/2008 to 12/19/2008.

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. Signature Orthopaedics's FEI number is 3007196858.

What types of violations has Signature Orthopaedics received?

Signature Orthopaedics 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 Signature Orthopaedics come from?

All FDA import refusal data for Signature Orthopaedics 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.