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Farmamedica de Guatemala SA

FDA import alert and refusal historyColonia Santa Mareia, GuatemalaFEI 3030554725

Recorded by FDA as FARMAMEDICA DE GUATEMALA SA

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

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As of October 26, 2026, Farmamedica de Guatemala SA is not on any FDA import alert in SupplierRadar's records; FDA refused 7 of its shipment lines between August 27, 2024 and October 2, 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 a · UNAPPROVED
Last warning letter
None found
Last inspection
None on record

Every FDA record for Farmamedica de Guatemala SA

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

2024

  1. Import refusal
    Refused, 2 lines in one entry: Vitamin aUNAPPROVEDEntry AEK-6406791-9Show 2 lines
    Source
  2. Import refusal
    Refused, 5 lines in one entry: Ashwagandha (herbal & botanicals, not teas)UNAPPROVEDEntry AEK-6338596-5Show 5 lines
    • Refused, Ashwagandha (herbal & botanicals, not teas)UNAPPROVEDEntry AEK-6338596-5Source
    • Refused, Ashwagandha (herbal & botanicals, not teas)UNAPPROVEDEntry AEK-6338596-5Source
    • Refused, Ashwagandha (herbal & botanicals, not teas)UNAPPROVEDEntry AEK-6338596-5Source
    • Refused, Ashwagandha (herbal & botanicals, not teas)UNAPPROVEDEntry AEK-6338596-5Source
    • Refused, Ashwagandha (herbal & botanicals, not teas)UNAPPROVEDEntry AEK-6338596-5Source
    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 Farmamedica de Guatemala SA

Is Farmamedica de Guatemala SA on an FDA import alert?
No listing for Farmamedica de Guatemala 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 de Guatemala SA?
Yes. FDA refused 7 shipment lines from Farmamedica de Guatemala SA between August 27, 2024 and October 2, 2024. The most recent, on October 2, 2024, was vitamin a, charged as UNAPPROVED (unapproved new drug).
Why did FDA refuse Farmamedica de Guatemala SA's shipments?
The most frequent charge is UNAPPROVED (unapproved new drug, 7 lines).
What is Farmamedica de Guatemala SA's FEI number?
Farmamedica de Guatemala SA's FDA Establishment Identifier (FEI) is 3030554725.

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Example subjectFarmamedica de Guatemala 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.