Total Control (Wa) Pty Ltd
✅ Low Risk
FEI: 3005157973 • Bassendean • AUSTRALIA
FEI Number
3005157973
Location
Bassendean
Country
AUSTRALIAAddress
Unit 5/12, , Bassendean, , Australia
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity violations.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/9/2005 | 89LYGMASSAGER, THERAPEUTIC, MANUAL | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Total Control (Wa) Pty Ltd's FDA import refusal history?
Total Control (Wa) Pty Ltd (FEI: 3005157973) has 1 FDA import refusal record(s) in our database, spanning from 6/9/2005 to 6/9/2005.
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. Total Control (Wa) Pty Ltd's FEI number is 3005157973.
What types of violations has Total Control (Wa) Pty Ltd received?
Total Control (Wa) 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 Total Control (Wa) Pty Ltd come from?
All FDA import refusal data for Total Control (Wa) 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.