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Laboratorios Santa Fe S.A.

FDA import alert and refusal historyGuatemala, GuatemalaFEI 3013246424

Recorded by FDA as LABORATORIOS SANTA FE S.A.

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Example subjectLaboratorios Santa Fe S.A added to Import Alert 16-129 (red list)

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As of October 26, 2026, Laboratorios Santa Fe S.A. is not on any FDA import alert in SupplierRadar's records; FDA refused 4 of its shipment lines between November 10, 2025 and February 18, 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
Pantothenic acid (panthenol) (vitamin) · UNAPPROVED
Last warning letter
None found
Last inspection
None on record

Every FDA record for Laboratorios Santa Fe S.A.

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

2026

  1. Import refusal
    Refused, Pantothenic acid (panthenol) (vitamin)UNAPPROVEDEntry 799-5106098-0
    Source

2025

  1. Import refusal
    Refused, Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c.NOT LISTEDEntry 799-0756064-6
    Source
  2. Import refusal
    Refused, Vitamin, n.e.c.UNAPPROVEDEntry 799-8601591-7
    Source
  3. Import refusal
    Refused, Foods with supplemental nutrients added, with or without artifical sweetnersNO ENGLISHUNAPPROVEDEntry 799-6873313-1
    Source

Refusal charges, in plain English

  • UNAPPROVED3 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.

  • 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.

Questions about Laboratorios Santa Fe S.A.

Is Laboratorios Santa Fe S.A. on an FDA import alert?
No listing for Laboratorios Santa Fe S.A. 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 Laboratorios Santa Fe S.A.?
Yes. FDA refused 4 shipment lines from Laboratorios Santa Fe S.A. between November 10, 2025 and February 18, 2026. The most recent, on February 18, 2026, was pantothenic acid (panthenol) (vitamin), charged as UNAPPROVED (unapproved new drug).
Why did FDA refuse Laboratorios Santa Fe S.A.'s shipments?
The most frequent charges are UNAPPROVED (unapproved new drug, 3 lines) and NO ENGLISH (required label information not in english, 1 line).
What is Laboratorios Santa Fe S.A.'s FEI number?
Laboratorios Santa Fe S.A.'s FDA Establishment Identifier (FEI) is 3013246424.

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Example subjectLaboratorios Santa Fe S.A 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.