Australian Wholesalers Pty Ltd
⚠️ Moderate Risk
FEI: 3003101118 • Cornubia, Queensland • AUSTRALIA
FEI Number
3003101118
Location
Cornubia, Queensland
Country
AUSTRALIAAddress
67-69 Roderick St, , Cornubia, Queensland, 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
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
Frequently Asked Questions
What is Australian Wholesalers Pty Ltd's FDA import refusal history?
Australian Wholesalers Pty Ltd (FEI: 3003101118) has 2 FDA import refusal record(s) in our database, spanning from 1/7/2002 to 1/7/2002.
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. Australian Wholesalers Pty Ltd's FEI number is 3003101118.
What types of violations has Australian Wholesalers Pty Ltd received?
Australian Wholesalers 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 Australian Wholesalers Pty Ltd come from?
All FDA import refusal data for Australian Wholesalers 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.