GRUPO RAZEL SA DE CV / Laboratorios RAZEL

1 record, newest first. Each line links to the FDA page it came from.

Refusal charges, in plain English

• 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.

• UNAPPROVED1 refused line

  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 GRUPO RAZEL SA DE CV / Laboratorios RAZEL

Is GRUPO RAZEL SA DE CV / Laboratorios RAZEL on an FDA import alert?

No listing for GRUPO RAZEL SA DE CV / Laboratorios RAZEL appears in the FDA import alerts SupplierRadar checked on October 26, 2026. Country-wide alerts may still apply to its products; see the El Salvador page.

Has FDA refused shipments from GRUPO RAZEL SA DE CV / Laboratorios RAZEL?

Yes. FDA refused 1 shipment line from GRUPO RAZEL SA DE CV / Laboratorios RAZEL on February 20, 2026. The most recent, on February 20, 2026, was l-carnitine (protein), charged as NOT LISTED (product not listed with fda).

Why did FDA refuse GRUPO RAZEL SA DE CV / Laboratorios RAZEL's shipments?

The most frequent charges are NOT LISTED (product not listed with fda, 1 line) and UNAPPROVED (unapproved new drug, 1 line).

What is GRUPO RAZEL SA DE CV / Laboratorios RAZEL's FEI number?

GRUPO RAZEL SA DE CV / Laboratorios RAZEL's FDA Establishment Identifier (FEI) is 3009080145.