Sanjiu Vitahut Australia Pty Ltd
⚠️ Moderate Risk
FEI: 3004992537 • North Rocks, New South Wales • AUSTRALIA
FEI Number
3004992537
Location
North Rocks, New South Wales
Country
AUSTRALIAAddress
39 Stirling Ave, , North Rocks, 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).
STERILITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to have been prepared, packed or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health.
Refusal History
Frequently Asked Questions
What is Sanjiu Vitahut Australia Pty Ltd's FDA import refusal history?
Sanjiu Vitahut Australia Pty Ltd (FEI: 3004992537) has 1 FDA import refusal record(s) in our database, spanning from 6/15/2005 to 6/15/2005.
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. Sanjiu Vitahut Australia Pty Ltd's FEI number is 3004992537.
What types of violations has Sanjiu Vitahut Australia Pty Ltd received?
Sanjiu Vitahut 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 Sanjiu Vitahut Australia Pty Ltd come from?
All FDA import refusal data for Sanjiu Vitahut 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.