Comercializadora Sofinic SA de CV

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

Refusal charges, in plain English

• COLOR LBLG1 refused line

  Artificial coloring not declared

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

• INCONSPICU1 refused line

  Required information not conspicuous

  Information required on the label appeared not to be placed prominently or conspicuously enough to be read and understood by an ordinary consumer.

• LABELING1 refused line

  Fair Packaging and Labeling Act

  The package appeared not to meet the Fair Packaging and Labeling Act because of the placement, form, or contents of a required label statement.

• LACKS FIRM1 refused line

  Manufacturer name and address missing

  The packaged product's label appeared not to show the name and place of business of the manufacturer, packer, or distributor.

• LACKS N/C1 refused line

  Net quantity statement missing

  The packaged food appeared not to carry an accurate statement of the quantity of contents, such as net weight, measure, or count, on its label.

• LIST INGRE1 refused line

  Ingredients not listed

  The product is made from two or more ingredients and the label appeared not to list the common or usual name of each one (or, for a juice beverage, the percentage of juice).

• 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.

• NUTRIT LBL1 refused line

  Nutrition information missing from label

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

Questions about Comercializadora Sofinic SA de CV

Is Comercializadora Sofinic SA de CV on an FDA import alert?

Yes. As of October 26, 2026, Comercializadora Sofinic SA de CV is on the red list of FDA Import Alert 45-02, “Foods with illegal or undeclared colors”, for baby bottle with chewing gum pieces inside (mamila); FDA published the listing on October 13, 2026.

Has FDA refused shipments from Comercializadora Sofinic SA de CV?

Yes. FDA refused 1 shipment line from Comercializadora Sofinic SA de CV on September 22, 2026. The most recent, on September 22, 2026, was chewing gum (without chocolate), charged as UNSAFE COL (color additive unsafe under section 721).

Why did FDA refuse Comercializadora Sofinic SA de CV's shipments?

The most frequent charges are COLOR LBLG (artificial coloring not declared, 1 line) and INCONSPICU (required information not conspicuous, 1 line).

What is Comercializadora Sofinic SA de CV's FEI number?

Comercializadora Sofinic SA de CV's FDA Establishment Identifier (FEI) is 3033765082.

Can shipments from Comercializadora Sofinic SA de CV still enter the U.S.?

Shipments of baby bottle with chewing gum pieces inside (mamila) from Comercializadora Sofinic SA de CV 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).