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Ursapharm Arzneimittel GmbH

FDA import alert and refusal historySaarbrucken, GermanyFEI 3004978466

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Example subjectUrsapharm Arzneimittel Gmb added to Import Alert 16-129 (red list)

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As of October 26, 2026, Ursapharm Arzneimittel GmbH is not on any FDA import alert in SupplierRadar's records; FDA refused 1 of its shipment line on March 27, 2026, most often for unapproved new drug (UNAPPROVED).

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

Current status

Import alerts
Not listed
Last import refusal
Omega-3 (fats and lipid substances) · UNAPPROVED
Last warning letter
None found
Last inspection
None on record

Every FDA record for Ursapharm Arzneimittel GmbH

1 record, newest first. Each line links to the FDA page it came from.

2026

  1. Import refusal
    Refused, Omega-3 (fats and lipid substances)UNAPPROVEDEntry 1FX-0407777-1
    Source

Refusal charges, in plain English

  • UNAPPROVED1 refused line

    Unapproved new drug

    The product appeared to be a new drug within the meaning of section 201(p) of the FD&C Act without an approved New Drug Application. FDA can apply this charge to a food or supplement whose labeling presents it for drug uses.

Questions about Ursapharm Arzneimittel GmbH

Is Ursapharm Arzneimittel GmbH on an FDA import alert?
No listing for Ursapharm Arzneimittel GmbH appears in the FDA import alerts SupplierRadar checked on October 26, 2026. Country-wide alerts may still apply to its products; see the Germany page.
Has FDA refused shipments from Ursapharm Arzneimittel GmbH?
Yes. FDA refused 1 shipment line from Ursapharm Arzneimittel GmbH on March 27, 2026. The most recent, on March 27, 2026, was omega-3 (fats and lipid substances), charged as UNAPPROVED (unapproved new drug).
Why did FDA refuse Ursapharm Arzneimittel GmbH's shipments?
The most frequent charge is UNAPPROVED (unapproved new drug, 1 line).
What is Ursapharm Arzneimittel GmbH's FEI number?
Ursapharm Arzneimittel GmbH's FDA Establishment Identifier (FEI) is 3004978466.

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Example subjectUrsapharm Arzneimittel Gmb 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.