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Denova Pharmaceutical SAS

FDA import alert and refusal historyCajica, ColombiaFEI 3009564761

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Example subjectDenova Pharmaceutical SA added to Import Alert 16-129 (red list)

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As of October 26, 2026, Denova Pharmaceutical SAS is not on any FDA import alert in SupplierRadar's records; FDA refused 1 of its shipment line on August 6, 2026, most often for frnmfgreg (FRNMFGREG).

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

Current status

Import alerts
Not listed
Last import refusal
Vitamin, n.e.c. · NOT LISTED
Last warning letter
None found
Last inspection
None on record

Every FDA record for Denova Pharmaceutical SAS

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

2026

  1. Import refusal
    Refused, Vitamin, n.e.c.NOT LISTEDNO ENGLISHFRNMFGREGUNAPPROVEDEntry AEK-0766811-3
    Source

Refusal charges, in plain English

  • FRNMFGREG1 refused line

    FRNMFGREG

  • NO ENGLISH1 refused line

    Required label information not in English

    Information that must appear on the label appeared not to be given in English, or not to be repeated in every language used on the label.

  • NOT LISTED1 refused line

    Product not listed with FDA

    The product appeared to be a drug or device that is not included in the listing FDA requires under section 510(j) of the FD&C Act.

  • 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 Denova Pharmaceutical SAS

Is Denova Pharmaceutical SAS on an FDA import alert?
No listing for Denova Pharmaceutical SAS appears in the FDA import alerts SupplierRadar checked on October 26, 2026. Country-wide alerts may still apply to its products; see the Colombia page.
Has FDA refused shipments from Denova Pharmaceutical SAS?
Yes. FDA refused 1 shipment line from Denova Pharmaceutical SAS on August 6, 2026. The most recent, on August 6, 2026, was vitamin, n.e.c., charged as NOT LISTED (product not listed with fda).
Why did FDA refuse Denova Pharmaceutical SAS's shipments?
The most frequent charges are FRNMFGREG (frnmfgreg, 1 line) and NO ENGLISH (required label information not in english, 1 line).
What is Denova Pharmaceutical SAS's FEI number?
Denova Pharmaceutical SAS's FDA Establishment Identifier (FEI) is 3009564761.

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Example subjectDenova Pharmaceutical SA 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.