SupplierRadar
Sign inStart free

Genoma Lab Guatemala

FDA import alert and refusal historyGuatemala, GuatemalaFEI 3030527942

Recorded by FDA as GENOMA LAB GUATEMALA

Watch this supplier

Watch this supplier

Get an email when FDA publishes anything new on Genoma Lab Guatemala.

Enter your work email and confirm with the link we send. Your first supplier is free, with no password and no card.

Example subjectGenoma Lab Guatemal added to Import Alert 16-129 (red list)

Free for one supplier. No password, no card.

As of October 26, 2026, Genoma Lab Guatemala is not on any FDA import alert in SupplierRadar's records; FDA refused 5 of its shipment lines between September 23, 2025 and September 9, 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 Genoma Lab Guatemala

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

2026

  1. Import refusal
    Refused, Vitamin b6 (pyridoxine)UNAPPROVEDEntry AEK-2008872-9
    Source
  2. Import refusal
    Refused, Vitamin b6 (pyridoxine)UNAPPROVEDEntry AEK-9452155-4
    Source
  3. Import refusal
    Refused, Vitamin b1 (thiamine)UNAPPROVEDEntry AEK-9452313-9
    Source
  4. Import refusal
    Refused, Vitamin b6 (pyridoxine)UNAPPROVEDEntry AEK-9451982-2
    Source

2025

  1. Import refusal
    Refused, Vitamin b6 (pyridoxine)UNAPPROVEDEntry AEK-7483646-9
    Source

Refusal charges, in plain English

  • UNAPPROVED5 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 Genoma Lab Guatemala

Is Genoma Lab Guatemala on an FDA import alert?
No listing for Genoma Lab Guatemala 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 Genoma Lab Guatemala?
Yes. FDA refused 5 shipment lines from Genoma Lab Guatemala between September 23, 2025 and September 9, 2026. The most recent, on September 9, 2026, was vitamin b6 (pyridoxine), charged as UNAPPROVED (unapproved new drug).
Why did FDA refuse Genoma Lab Guatemala's shipments?
The most frequent charge is UNAPPROVED (unapproved new drug, 5 lines).
What is Genoma Lab Guatemala's FEI number?
Genoma Lab Guatemala's FDA Establishment Identifier (FEI) is 3030527942.

Buying from Genoma Lab Guatemala?

Watch it and get the FDA record the day it changes. Free for one supplier.

Watch this supplier

Watch this supplier

Get an email when FDA publishes anything new on Genoma Lab Guatemala.

Enter your work email and confirm with the link we send. Your first supplier is free, with no password and no card.

Example subjectGenoma Lab Guatemal added to Import Alert 16-129 (red list)

Free for one supplier. No password, no card.

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.