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Denk Pharma GmbH & Co. KG

FDA import alert and refusal historyMunich, GermanyFEI 3012791190

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Example subjectDenk Pharma GmbH & Co. K added to Import Alert 16-129 (red list)

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As of October 26, 2026, Denk Pharma GmbH & Co. KG is not on any FDA import alert in SupplierRadar's records; FDA refused 14 of its shipment lines between October 21, 2016 and April 11, 2025, most often for unauthorized nutrient content or health claim (HEALTH C).

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

Current status

Import alerts
Not listed
Last import refusal
Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c. · UNAPPROVED
Last warning letter
None found
Last inspection
None on record

Every FDA record for Denk Pharma GmbH & Co. KG

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

2025

  1. Import refusal
    Refused, Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c.UNAPPROVEDEntry AEK-8422302-1
    Source

2016

  1. Import refusal
    Refused, 13 lines in one entry: Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c.; Protein n.e.c. and 5 moreLABELINGHEALTH CEntry WDN-4102340-0Show 13 lines
    Source

Refusal charges, in plain English

  • HEALTH C13 refused lines

    Unauthorized nutrient content or health claim

    The label or labeling appeared to carry a nutrient content claim or health claim that is not authorized.

  • LABELING13 refused lines

    Fair Packaging and Labeling Act

    The package appeared not to meet the Fair Packaging and Labeling Act because of the placement, form, or contents of a required label statement.

  • 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 Denk Pharma GmbH & Co. KG

Is Denk Pharma GmbH & Co. KG on an FDA import alert?
No listing for Denk Pharma GmbH & Co. KG 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 Denk Pharma GmbH & Co. KG?
Yes. FDA refused 14 shipment lines from Denk Pharma GmbH & Co. KG between October 21, 2016 and April 11, 2025. The most recent, on April 11, 2025, was vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c., charged as UNAPPROVED (unapproved new drug).
Why did FDA refuse Denk Pharma GmbH & Co. KG's shipments?
The most frequent charges are HEALTH C (unauthorized nutrient content or health claim, 13 lines) and LABELING (fair packaging and labeling act, 13 lines).
What is Denk Pharma GmbH & Co. KG's FEI number?
Denk Pharma GmbH & Co. KG's FDA Establishment Identifier (FEI) is 3012791190.

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Example subjectDenk Pharma GmbH & Co. K 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.