Ultra Mix (Aust) Pty Ltd
⚠️ Moderate Risk
FEI: 3009751549 • West Footscray, Victoria • AUSTRALIA
FEI Number
3009751549
Location
West Footscray, Victoria
Country
AUSTRALIAAddress
6 Mcarthur St, , West Footscray, Victoria, 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
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
UNSAFE COL
The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).
NUTRIT LBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.
HEALTH C
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling bears an unauthorized nutrient content/health claim.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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 |
|---|---|---|---|
| 7/22/2016 | 55PY93EUCALYPTUS OIL (PHARMACEUTIC NECESSITY - FLAVOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/12/2016 | 66YBY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | Florida District Office (FLA-DO) | |
| 7/12/2016 | 66YBY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | Florida District Office (FLA-DO) | |
| 7/12/2016 | 54ACH99VITAMIN, N.E.C. | Florida District Office (FLA-DO) | |
| 6/23/2016 | 66VIE99MISCELLANEOUS PATENT MEDICINES, ETC. | New Orleans District Office (NOL-DO) | |
| 5/25/2016 | 66YBY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Ultra Mix (Aust) Pty Ltd's FDA import refusal history?
Ultra Mix (Aust) Pty Ltd (FEI: 3009751549) has 6 FDA import refusal record(s) in our database, spanning from 5/25/2016 to 7/22/2016.
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. Ultra Mix (Aust) Pty Ltd's FEI number is 3009751549.
What types of violations has Ultra Mix (Aust) Pty Ltd received?
Ultra Mix (Aust) Pty Ltd has been cited for 8 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 Ultra Mix (Aust) Pty Ltd come from?
All FDA import refusal data for Ultra Mix (Aust) 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.