Laboratorios PiSA, S.A. de C.V. (Planta Calle 7)

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

Refusal charges, in plain English

• UNSAFE COL3 refused lines

  Color additive unsafe under section 721

  The product appeared to be, or to contain, a color additive that is unsafe within the meaning of section 721(a) of the FD&C Act, the section that governs which color additives may be used and how.

• COLOR LBLG2 refused lines

  Artificial coloring not declared

  The product appeared to contain an artificial coloring without labeling that states that fact.

• 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.

• NO ENGLISH1 refused line

  Required label information not in English

  Information that must appear on the label appeared not to be given in English, or not to be repeated in every language used on the label.

Questions about Laboratorios PiSA, S.A. de C.V. (Planta Calle 7)

Is Laboratorios PiSA, S.A. de C.V. (Planta Calle 7) on an FDA import alert?

Yes. As of October 27, 2026, Laboratorios PiSA, S.A. de C.V. (Planta Calle 7) is on the red list of FDA Import Alert 45-02, “Foods with illegal or undeclared colors”, for electrolit electolyte beverage pineapple; FDA published the listing on June 18, 2013.

Has FDA refused shipments from Laboratorios PiSA, S.A. de C.V. (Planta Calle 7)?

Yes. FDA refused 5 shipment lines from Laboratorios PiSA, S.A. de C.V. (Planta Calle 7) between August 31, 2021 and July 2, 2024. The most recent, on July 2, 2024, was oral rehydration products, charged as UNSAFE COL (color additive unsafe under section 721).

Why did FDA refuse Laboratorios PiSA, S.A. de C.V. (Planta Calle 7)'s shipments?

The most frequent charges are UNSAFE COL (color additive unsafe under section 721, 3 lines) and COLOR LBLG (artificial coloring not declared, 2 lines).

What is Laboratorios PiSA, S.A. de C.V. (Planta Calle 7)'s FEI number?

Laboratorios PiSA, S.A. de C.V. (Planta Calle 7)'s FDA Establishment Identifier (FEI) is 3005440755.

Can shipments from Laboratorios PiSA, S.A. de C.V. (Planta Calle 7) still enter the U.S.?

Shipments of electrolit electolyte beverage pineapple from Laboratorios PiSA, S.A. de C.V. (Planta Calle 7) can be detained without physical examination under Import Alert 45-02; 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).