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Peter Maccallum Canser Research Centre

✅ Low Risk

FEI: 3007540643 • East Melbourne • AUSTRALIA

FEI

FEI Number

3007540643

📍

Location

East Melbourne

🇦🇺

Country

AUSTRALIA
🏢

Address

01 St Andrews Pl, , East Melbourne, , 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
2
Unique Violations
8/21/2009
Latest Refusal
8/21/2009
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

3411×

REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

5081×

NO 510(K)

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.

Refusal History

DateProductViolationsDivision
8/21/2009
74LOSSYSTEM, ECG ANALYSIS,
341REGISTERED
508NO 510(K)
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Peter Maccallum Canser Research Centre's FDA import refusal history?

Peter Maccallum Canser Research Centre (FEI: 3007540643) has 1 FDA import refusal record(s) in our database, spanning from 8/21/2009 to 8/21/2009.

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. Peter Maccallum Canser Research Centre's FEI number is 3007540643.

What types of violations has Peter Maccallum Canser Research Centre received?

Peter Maccallum Canser Research Centre 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 Peter Maccallum Canser Research Centre come from?

All FDA import refusal data for Peter Maccallum Canser Research Centre 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.