Laboratorios Combisa S.A. de C.V.

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

Refusal charges, in plain English

• FALSE2 refused lines

  False or misleading labeling

  The labeling appeared to be false or misleading in some particular.

• NUTRIT LBL2 refused lines

  Nutrition information missing from label

  The label or labeling appeared not to carry the nutrition information that U.S. law requires for the food.

• OMITTED1 refused line

  OMITTED

• 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 Laboratorios Combisa S.A. de C.V.

Is Laboratorios Combisa S.A. de C.V. on an FDA import alert?

Yes. As of October 26, 2026, Laboratorios Combisa S.A. de C.V. is on the red list of FDA Import Alert 99-39, “Imported foods that appear to be misbranded”, for calmattos syrup; sugar free dietary supplement; FDA published the listing on July 17, 2024.

Has FDA refused shipments from Laboratorios Combisa S.A. de C.V.?

Yes. FDA refused 5 shipment lines from Laboratorios Combisa S.A. de C.V. between May 23, 2019 and November 5, 2024. The most recent, on November 5, 2024, was multiple vitamins (mvi-12 vitamin combo) (vitamin), charged as FALSE (false or misleading labeling).

Why did FDA refuse Laboratorios Combisa S.A. de C.V.'s shipments?

The most frequent charges are FALSE (false or misleading labeling, 2 lines) and NUTRIT LBL (nutrition information missing from label, 2 lines).

What is Laboratorios Combisa S.A. de C.V.'s FEI number?

Laboratorios Combisa S.A. de C.V.'s FDA Establishment Identifier (FEI) is 3003922103.

Can shipments from Laboratorios Combisa S.A. de C.V. still enter the U.S.?

Shipments of calmattos syrup; sugar free dietary supplement from Laboratorios Combisa S.A. de C.V. can be detained without physical examination under Import Alert 99-39; FDA releases them only if evidence shows they do not have the listed violation. Importers must consider this listing in their FSVP evaluation (21 CFR 1.505).