Leica Biosystems Melbourne Pty Ltd
⚠️ Moderate Risk
FEI: 3006461677 • Mount Waverley, Victoria • AUSTRALIA
FEI Number
3006461677
Location
Mount Waverley, Victoria
Country
AUSTRALIAAddress
495 Blackburn Road, , Mount Waverley, Victoria, Australia
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
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
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).
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/24/2017 | 81JPASYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 10/26/2016 | 75NSUINSTRUMENTATION FOR CLINICAL MULIPLEX TEST SYSTEMS | 118NOT LISTED | Seattle District Office (SEA-DO) |
| 10/26/2016 | 75NSUINSTRUMENTATION FOR CLINICAL MULIPLEX TEST SYSTEMS | 118NOT LISTED | Seattle District Office (SEA-DO) |
| 10/26/2016 | 75NSUINSTRUMENTATION FOR CLINICAL MULIPLEX TEST SYSTEMS | 118NOT LISTED | Seattle District Office (SEA-DO) |
| 6/3/2015 | 81JPASYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES | Division of Southeast Imports (DSEI) | |
| 6/3/2015 | 81JPASYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES | Division of Southeast Imports (DSEI) | |
| 6/3/2015 | 81JPASYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES | Division of Southeast Imports (DSEI) | |
| 6/3/2015 | 81JPASYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Leica Biosystems Melbourne Pty Ltd's FDA import refusal history?
Leica Biosystems Melbourne Pty Ltd (FEI: 3006461677) has 8 FDA import refusal record(s) in our database, spanning from 6/3/2015 to 3/24/2017.
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. Leica Biosystems Melbourne Pty Ltd's FEI number is 3006461677.
What types of violations has Leica Biosystems Melbourne Pty Ltd received?
Leica Biosystems Melbourne 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 Leica Biosystems Melbourne Pty Ltd come from?
All FDA import refusal data for Leica Biosystems Melbourne 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.