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Farmamedica SA

FDA import alert and refusal historyHuehuetenango, GuatemalaFEI 3039377592

Recorded by FDA as FARMAMEDICA SA

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Example subjectFarmamedica S added to Import Alert 16-129 (red list)

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As of October 26, 2026, Farmamedica SA is not on any FDA import alert in SupplierRadar's records; FDA refused 5 of its shipment lines between September 18, 2025 and July 11, 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
Vitamin b12 (cyanocobalamin) · UNAPPROVED
Last warning letter
None found
Last inspection
None on record

Every FDA record for Farmamedica SA

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

2026

  1. Import refusal
    Refused, 2 lines in one entry: Vitamin b12 (cyanocobalamin)UNAPPROVEDEntry AEK-0560044-9Show 2 lines
    Source
  2. Import refusal
    Refused, 2 lines in one entry: Vitamin b12 (cyanocobalamin)UNAPPROVEDEntry AEK-9434994-9Show 2 lines
    Source

2025

  1. Import refusal
    Refused, Vitamin c (ascorbic acid)NOT LISTEDUNAPPROVEDEntry AEK-7601865-2
    Source

Refusal charges, in plain English

  • UNAPPROVED5 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.

  • 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.

Questions about Farmamedica SA

Is Farmamedica SA on an FDA import alert?
No listing for Farmamedica SA 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 Farmamedica SA?
Yes. FDA refused 5 shipment lines from Farmamedica SA between September 18, 2025 and July 11, 2026. The most recent, on July 11, 2026, was vitamin b12 (cyanocobalamin), charged as UNAPPROVED (unapproved new drug).
Why did FDA refuse Farmamedica SA's shipments?
The most frequent charges are UNAPPROVED (unapproved new drug, 5 lines) and NOT LISTED (product not listed with fda, 1 line).
What is Farmamedica SA's FEI number?
Farmamedica SA's FDA Establishment Identifier (FEI) is 3039377592.

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Example subjectFarmamedica S 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.