Proudex Austrlaia Pty Ltd
⚠️ Moderate Risk
FEI: 3004907432 • Alexandria, New South Wales • AUSTRALIA
FEI Number
3004907432
Location
Alexandria, New South Wales
Country
AUSTRALIAAddress
17-21 Bowden St, , Alexandria, New South Wales, 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).
FILTHY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to consist in whole or in part of a filthy, putrid, or decomposed substance or be otherwise unfit for food.
Refusal History
Frequently Asked Questions
What is Proudex Austrlaia Pty Ltd's FDA import refusal history?
Proudex Austrlaia Pty Ltd (FEI: 3004907432) has 1 FDA import refusal record(s) in our database, spanning from 1/12/2005 to 1/12/2005.
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. Proudex Austrlaia Pty Ltd's FEI number is 3004907432.
What types of violations has Proudex Austrlaia Pty Ltd received?
Proudex Austrlaia 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 Proudex Austrlaia Pty Ltd come from?
All FDA import refusal data for Proudex Austrlaia 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.