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Donovan Werke

FDA import alert and refusal historyGuatemala, GuatemalaFEI 3011068023

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Example subjectDonovan Werk added to Import Alert 16-129 (red list)

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As of October 26, 2026, Donovan Werke is not on any FDA import alert in SupplierRadar's records; FDA refused 7 of its shipment lines between May 25, 2018 and August 25, 2024, 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
Vitamin b1 (thiamine) · UNAPPROVED
Last warning letter
None found
Last inspection
None on record

Every FDA record for Donovan Werke

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

2024

  1. Import refusal
    Refused, Vitamin b1 (thiamine)UNAPPROVEDEntry AEK-5661544-4
    Source

2020

  1. Import refusal
    Refused, 2 lines in one entry: Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c.UNAPPROVEDEntry 799-7839171-0Show 2 lines
    • Refused, Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c.UNAPPROVEDEntry 799-7839171-0Source
    • Refused, Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c.UNAPPROVEDEntry 799-7839171-0Source
    Source
  2. Import refusal
    Refused, Vitamin b1 (thiamine)UNAPPROVEDEntry 799-7795095-3
    Source

2018

  1. Import refusal
    Refused, 3 lines in one entry: Vitamin b12 (cyanocobalamin)UNAPPROVEDEntry AEK-4544605-8Show 3 lines
    Source

Refusal charges, in plain English

  • UNAPPROVED7 refused lines

    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 Donovan Werke

Is Donovan Werke on an FDA import alert?
No listing for Donovan Werke appears in the FDA import alerts SupplierRadar checked on October 26, 2026. Country-wide alerts may still apply to its products; see the Guatemala page.
Has FDA refused shipments from Donovan Werke?
Yes. FDA refused 7 shipment lines from Donovan Werke between May 25, 2018 and August 25, 2024. The most recent, on August 25, 2024, was vitamin b1 (thiamine), charged as UNAPPROVED (unapproved new drug).
Why did FDA refuse Donovan Werke's shipments?
The most frequent charge is UNAPPROVED (unapproved new drug, 7 lines).
What is Donovan Werke's FEI number?
Donovan Werke's FDA Establishment Identifier (FEI) is 3011068023.

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Example subjectDonovan Werk 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.