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Laboratorios Fardel

FDA import alert and refusal historySan Salvador, El SalvadorFEI 3017056920

Recorded by FDA as LABORATORIOS FARDEL

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Example subjectLaboratorios Farde added to Import Alert 16-129 (red list)

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As of October 25, 2026, Laboratorios Fardel is not on any FDA import alert in SupplierRadar's records; FDA refused 2 of its shipment lines between August 9, 2022 and December 9, 2025, 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 b1 (thiamine) · UNAPPROVED
Last warning letter
None found
Last inspection
None on record

Every FDA record for Laboratorios Fardel

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

2025

  1. Import refusal
    Refused, Vitamin b1 (thiamine)UNAPPROVEDEntry AEK-9070754-6
    Source

2022

  1. Import refusal
    Refused, Vitamin b12 (cyanocobalamin)UNAPPROVEDEntry AMN-0076232-4
    Source

Refusal charges, in plain English

  • UNAPPROVED2 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 Laboratorios Fardel

Is Laboratorios Fardel on an FDA import alert?
No listing for Laboratorios Fardel appears in the FDA import alerts SupplierRadar checked on October 25, 2026. Country-wide alerts may still apply to its products; see the El Salvador page.
Has FDA refused shipments from Laboratorios Fardel?
Yes. FDA refused 2 shipment lines from Laboratorios Fardel between August 9, 2022 and December 9, 2025. The most recent, on December 9, 2025, was vitamin b1 (thiamine), charged as UNAPPROVED (unapproved new drug).
Why did FDA refuse Laboratorios Fardel's shipments?
The most frequent charge is UNAPPROVED (unapproved new drug, 2 lines).
What is Laboratorios Fardel's FEI number?
Laboratorios Fardel's FDA Establishment Identifier (FEI) is 3017056920.

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Example subjectLaboratorios Farde 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.