Laboratorio Genesis Labgenesis Cia. Ltda.
FDA import alert and refusal historyAmbato, EcuadorFEI 3024468579
Recorded by FDA as LABORATORIO GENESIS LABGENESIS CIA. LTDA.
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
- Import refusalRefused, Mineral n.e.c.UNAPPROVEDEntry BFV-0851739-3Source
- Import refusalRefused, Herbals & botanicals (not teas), n.e.c.UNAPPROVEDEntry 799-6060606-0Source
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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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.