Painaway Australia Pty Ltd
⚠️ Moderate Risk
FEI: 3011779117 • Eastern Creekeastern Creek • AUSTRALIA
FEI Number
3011779117
Location
Eastern Creekeastern Creek
Country
AUSTRALIAAddress
10/16 Groves Ave, , Eastern Creekeastern Creek, , 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).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/13/2016 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 10/13/2016 | 53LI99OTHER SKIN CARE PREPARATIONS, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 10/13/2016 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 10/13/2016 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 10/13/2016 | 53LA99OTHER SKIN CARE PREPARATIONS, N.E.C. | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Painaway Australia Pty Ltd's FDA import refusal history?
Painaway Australia Pty Ltd (FEI: 3011779117) has 5 FDA import refusal record(s) in our database, spanning from 10/13/2016 to 10/13/2016.
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. Painaway Australia Pty Ltd's FEI number is 3011779117.
What types of violations has Painaway Australia Pty Ltd received?
Painaway 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 Painaway Australia Pty Ltd come from?
All FDA import refusal data for Painaway 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.