Olympus Australia Pty Ltd
⚠️ Moderate Risk
FEI: 3010574342 • Notting Hill, Victoria • AUSTRALIA
FEI Number
3010574342
Location
Notting Hill, Victoria
Country
AUSTRALIAAddress
3 Acacia Pl, , Notting Hill, 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).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/3/2015 | 78FDSGASTROSCOPE, GASTRO-UROLOGY | Division of Southeast Imports (DSEI) | |
| 9/3/2015 | 78FDFCOLONOSCOPE, GASTRO-UROLOGY | Division of Southeast Imports (DSEI) | |
| 9/3/2015 | 78KOGENDOSCOPE AND/OR ACCESSORIES | Division of Southeast Imports (DSEI) | |
| 9/3/2015 | 78KOGENDOSCOPE AND/OR ACCESSORIES | Division of Southeast Imports (DSEI) | |
| 9/3/2015 | 78KOGENDOSCOPE AND/OR ACCESSORIES | Division of Southeast Imports (DSEI) | |
| 9/3/2015 | 78KOGENDOSCOPE AND/OR ACCESSORIES | Division of Southeast Imports (DSEI) | |
| 9/3/2015 | 78KOGENDOSCOPE AND/OR ACCESSORIES | Division of Southeast Imports (DSEI) | |
| 9/3/2015 | 78KOGENDOSCOPE AND/OR ACCESSORIES | Division of Southeast Imports (DSEI) | |
| 9/3/2015 | 78KOGENDOSCOPE AND/OR ACCESSORIES | Division of Southeast Imports (DSEI) | |
| 9/3/2015 | 78KOGENDOSCOPE AND/OR ACCESSORIES | Division of Southeast Imports (DSEI) | |
| 9/3/2015 | 78KOGENDOSCOPE AND/OR ACCESSORIES | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Olympus Australia Pty Ltd's FDA import refusal history?
Olympus Australia Pty Ltd (FEI: 3010574342) has 11 FDA import refusal record(s) in our database, spanning from 9/3/2015 to 9/3/2015.
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. Olympus Australia Pty Ltd's FEI number is 3010574342.
What types of violations has Olympus Australia Pty Ltd received?
Olympus Australia 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 Olympus Australia Pty Ltd come from?
All FDA import refusal data for Olympus Australia 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.