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Surgi Supplies International Pty Ltd

✅ Low Risk

FEI: 3009025655 • Thomastown, Victoria • AUSTRALIA

FEI

FEI Number

3009025655

📍

Location

Thomastown, Victoria

🇦🇺

Country

AUSTRALIA
🏢

Address

Thomastown, U 3 29 Macquarie Dr, Thomastown, Victoria, 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
1/4/2005
Latest Refusal
1/4/2005
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
1/4/2005
85KOHINSTRUMENT, MANUAL, GENERAL OBSTETRIC-GYNECOLOGIC
118NOT LISTED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Surgi Supplies International Pty Ltd's FDA import refusal history?

Surgi Supplies International Pty Ltd (FEI: 3009025655) has 1 FDA import refusal record(s) in our database, spanning from 1/4/2005 to 1/4/2005.

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. Surgi Supplies International Pty Ltd's FEI number is 3009025655.

What types of violations has Surgi Supplies International Pty Ltd received?

Surgi Supplies International 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 Surgi Supplies International Pty Ltd come from?

All FDA import refusal data for Surgi Supplies International 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.