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Laboratorio Genesis Labgenesis Cia. Ltda.

FDA import alert and refusal historyAmbato, EcuadorFEI 3024468579

Recorded by FDA as LABORATORIO GENESIS LABGENESIS CIA. LTDA.

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Example subjectLaboratorio Genesis Labgenesis Cia. Ltda added to Import Alert 16-129 (red list)

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As of October 26, 2026, Laboratorio Genesis Labgenesis Cia. Ltda. is not on any FDA import alert in SupplierRadar's records; FDA refused 2 of its shipment lines between March 18, 2025 and April 24, 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
Mineral n.e.c. · UNAPPROVED
Last warning letter
None found
Last inspection
None on record

Every FDA record for Laboratorio Genesis Labgenesis Cia. Ltda.

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

2025

  1. Import refusal
    Refused, Mineral n.e.c.UNAPPROVEDEntry BFV-0851739-3
    Source
  2. Import refusal
    Refused, Herbals & botanicals (not teas), n.e.c.UNAPPROVEDEntry 799-6060606-0
    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 Laboratorio Genesis Labgenesis Cia. Ltda.

Is Laboratorio Genesis Labgenesis Cia. Ltda. on an FDA import alert?
No listing for Laboratorio Genesis Labgenesis Cia. Ltda. appears in the FDA import alerts SupplierRadar checked on October 26, 2026. Country-wide alerts may still apply to its products; see the Ecuador page.
Has FDA refused shipments from Laboratorio Genesis Labgenesis Cia. Ltda.?
Yes. FDA refused 2 shipment lines from Laboratorio Genesis Labgenesis Cia. Ltda. between March 18, 2025 and April 24, 2025. The most recent, on April 24, 2025, was mineral n.e.c., charged as UNAPPROVED (unapproved new drug).
Why did FDA refuse Laboratorio Genesis Labgenesis Cia. Ltda.'s shipments?
The most frequent charge is UNAPPROVED (unapproved new drug, 2 lines).
What is Laboratorio Genesis Labgenesis Cia. Ltda.'s FEI number?
Laboratorio Genesis Labgenesis Cia. Ltda.'s FDA Establishment Identifier (FEI) is 3024468579.

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Example subjectLaboratorio Genesis Labgenesis Cia. Ltda 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.