SupplierRadar

Medikane Operations Pty Ltd

FDA import alert and refusal historyNorth Ryde, AustraliaFEI 3032949239

Recorded by FDA as MEDIKANE OPERATIONS PTY LTD

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Example subjectMedikane Operations Pty Lt added to Import Alert 16-129 (red list)

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As of October 26, 2026, Medikane Operations Pty Ltd is not on any FDA import alert in SupplierRadar's records; FDA refused 4 of its shipment lines on December 11, 2024, most often for artificial coloring not declared (COLOR LBLG).

Data from FDA public records, last checked . Request a correction

Current status

Import alerts
Not listed
Last import refusal
Fiber, n.e.c. · COLOR LBLG
Last warning letter
None found
Last inspection
None on record

Every FDA record for Medikane Operations Pty Ltd

4 records, newest first. Each line links to the FDA page it came from.

2024

  1. Import refusal
    Refused, 4 lines in one entry: Fiber, n.e.c.COLOR LBLGNCONTACTNUTRIT LBLEntry 799-4429480-1Show 4 lines
    Source

Refusal charges, in plain English

  • COLOR LBLG4 refused lines

    Artificial coloring not declared

    The product appeared to contain an artificial coloring without labeling that states that fact.

  • NCONTACT4 refused lines

    No U.S. adverse event contact on supplement label

    The dietary supplement label appeared not to show a U.S. address or phone number through which a serious adverse event can be reported.

  • NUTRIT LBL4 refused lines

    Nutrition information missing from label

    The label or labeling appeared not to carry the nutrition information that U.S. law requires for the food.

Questions about Medikane Operations Pty Ltd

Is Medikane Operations Pty Ltd on an FDA import alert?
No listing for Medikane Operations Pty Ltd appears in the FDA import alerts SupplierRadar checked on October 26, 2026. Country-wide alerts may still apply to its products; see the Australia page.
Has FDA refused shipments from Medikane Operations Pty Ltd?
Yes. FDA refused 4 shipment lines from Medikane Operations Pty Ltd on December 11, 2024. The most recent, on December 11, 2024, was fiber, n.e.c., charged as COLOR LBLG (artificial coloring not declared).
Why did FDA refuse Medikane Operations Pty Ltd's shipments?
The most frequent charges are COLOR LBLG (artificial coloring not declared, 4 lines) and NCONTACT (no u.s. adverse event contact on supplement label, 4 lines).
What is Medikane Operations Pty Ltd's FEI number?
Medikane Operations Pty Ltd's FDA Establishment Identifier (FEI) is 3032949239.

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Example subjectMedikane Operations Pty Lt added to Import Alert 16-129 (red list)

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SupplierRadar is not affiliated with the U.S. Food and Drug Administration. Data comes from public FDA records and may contain errors. This is not legal advice; importers remain responsible for their supplier evaluations.