MEDIKANE OPERATIONS PTY LTD
⚠️ Moderate Risk
FEI: 3032949239 • North Ryde, New South Wales • AUSTRALIA
FEI Number
3032949239
Location
North Ryde, New South Wales
Country
AUSTRALIAAddress
1 Rivett Road, , North Ryde, 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
COLOR LBLG
The article appears to contain an artificial coloring and it fails to bear labeling stating that fact.
NCONTACT
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(y) of the FD&C Act in that the dietary supplement label fails to bear a domestic address or phone number through which the responsible person (as described in section 761 of the FD&C Act) may receive a report of a serious adverse event with such dietary supplement.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/11/2024 | 54ICY99FIBER, N.E.C. | Division of Southeast Imports (DSEI) | |
| 12/11/2024 | 54ICY99FIBER, N.E.C. | Division of Southeast Imports (DSEI) | |
| 12/11/2024 | 54ICY99FIBER, N.E.C. | Division of Southeast Imports (DSEI) | |
| 12/11/2024 | 54ICY99FIBER, N.E.C. | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is MEDIKANE OPERATIONS PTY LTD's FDA import refusal history?
MEDIKANE OPERATIONS PTY LTD (FEI: 3032949239) has 4 FDA import refusal record(s) in our database, spanning from 12/11/2024 to 12/11/2024.
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. MEDIKANE OPERATIONS PTY LTD's FEI number is 3032949239.
What types of violations has MEDIKANE OPERATIONS PTY LTD received?
MEDIKANE OPERATIONS PTY LTD has been cited for 3 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 MEDIKANE OPERATIONS PTY LTD come from?
All FDA import refusal data for MEDIKANE OPERATIONS 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.