Somafaco, SA

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

Refusal charges, in plain English

• UNSAFE COL22 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.

• FSVP VIO20 refused lines

  Importer not in compliance with FSVP

  The importer of record appeared not to be in compliance with the Foreign Supplier Verification Program requirements of section 805 of the FD&C Act. The charge concerns the importer's program, not a test result on the food.

• NUTRIT LBL15 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.

• NO ENGLISH7 refused lines

  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.

• COLOR LBLG5 refused lines

  Artificial coloring not declared

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

• LABELING5 refused lines

  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.

• YELLOW #53 refused lines

  FD&C Yellow No. 5 not declared

  The food appeared to contain the color additive FD&C Yellow No. 5 without declaring it on the label as 21 CFR 74.705 requires.

• LACKS N/C2 refused lines

  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.

Questions about Somafaco, SA

Is Somafaco, SA on an FDA import alert?

Yes. As of October 26, 2026, Somafaco, SA is on the red list of FDA Import Alert 99-39, “Imported foods that appear to be misbranded”, for powder preparation for flan - chocolate hazelnut aroma; powder preparation for flan - chocolate aroma; FDA published the listing on October 12, 2023.

Has FDA refused shipments from Somafaco, SA?

Yes. FDA refused 55 shipment lines from Somafaco, SA between June 15, 2017 and March 16, 2026. The most recent, on March 16, 2026, was custard pudding (pie) mix, n.e.c., charged as NO ENGLISH (required label information not in english).

Why did FDA refuse Somafaco, SA's shipments?

The most frequent charges are UNSAFE COL (color additive unsafe under section 721, 22 lines) and FSVP VIO (importer not in compliance with fsvp, 20 lines).

When was Somafaco, SA last inspected by FDA?

FDA's most recent inspection of Somafaco, SA with a final classification is dated March 8, 2019 and was classified NAI (No Action Indicated).

What is Somafaco, SA's FEI number?

Somafaco, SA's FDA Establishment Identifier (FEI) is 3006485523.

Can shipments from Somafaco, SA still enter the U.S.?

Shipments of powder preparation for flan - chocolate hazelnut aroma; powder preparation for flan - chocolate aroma from Somafaco, SA 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).