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Farmamedica SA

FDA import alert and refusal historyGuatemala, GuatemalaFEI 3035369123

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 6 of its shipment lines between June 13, 2025 and January 20, 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 b6 (pyridoxine) · UNAPPROVED
Last warning letter
None found
Last inspection
None on record

Every FDA record for Farmamedica SA

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

2026

  1. Import refusal
    Refused, 2 lines in one entry: Vitamin b6 (pyridoxine); Glycine (protein)UNAPPROVEDEntry AEK-9237596-1Show 2 lines
    Source

2025

  1. Import refusal
    Refused, Vitamin, n.e.c.UNAPPROVEDEntry AEK-7261512-1
    Source
  2. Import refusal
    Refused, 2 lines in one entry: Vitamin b6 (pyridoxine); Vitamin b12 (cyanocobalamin)UNAPPROVEDEntry AEK-7221538-5Show 2 lines
    Source
  3. Import refusal
    Refused, Vitamin, n.e.c.UNAPPROVEDEntry AEK-8382473-8
    Source

Refusal charges, in plain English

  • UNAPPROVED6 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 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 6 shipment lines from Farmamedica SA between June 13, 2025 and January 20, 2026. The most recent, on January 20, 2026, was vitamin b6 (pyridoxine), charged as UNAPPROVED (unapproved new drug).
Why did FDA refuse Farmamedica SA's shipments?
The most frequent charge is UNAPPROVED (unapproved new drug, 6 lines).
What is Farmamedica SA's FEI number?
Farmamedica SA's FDA Establishment Identifier (FEI) is 3035369123.

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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.