Marcas Nestle SA de CV

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

Refusal charges, in plain English

• NO PROCESS21 refused lines

  No scheduled process filed

  The manufacturer appeared not to have filed a scheduled process with FDA, which 21 CFR Part 108 requires for low-acid canned and acidified foods, so the product is treated as made under insanitary conditions.

• UNSAFE ADD19 refused lines

  Food additive unsafe under section 409

  The product appeared to contain a food additive that is unsafe within the meaning of section 409 of the FD&C Act, the section that governs which food additives may be used and under what conditions.

• NEEDS FCE18 refused lines

  Processor not registered for canned or acidified foods

  The manufacturer appeared not to be registered with FDA as a low-acid canned food or acidified food processor, as 21 CFR 108.25 and 108.35 require.

• NUTRIT LBL18 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.

• UNAPPROVED16 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.

• INCONSPICU7 refused lines

  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.

• NO ENGLISH6 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.

• LABELING4 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.

Questions about Marcas Nestle SA de CV

Is Marcas Nestle SA de CV on an FDA import alert?

Yes. As of October 26, 2026, Marcas Nestle SA de CV is on the red list of FDA Import Alert 99-45, “Foods that are or contain an unsafe food additive”, for nestle nido kinder milk based powder; FDA published the listing on April 26, 2022.

Has FDA refused shipments from Marcas Nestle SA de CV?

Yes. FDA refused 55 shipment lines from Marcas Nestle SA de CV between October 17, 2017 and January 8, 2025. The most recent, on January 8, 2025, was milk, dried, charged as UNSAFE ADD (food additive unsafe under section 409).

Why did FDA refuse Marcas Nestle SA de CV's shipments?

The most frequent charges are NO PROCESS (no scheduled process filed, 21 lines) and UNSAFE ADD (food additive unsafe under section 409, 19 lines).

What is Marcas Nestle SA de CV's FEI number?

Marcas Nestle SA de CV's FDA Establishment Identifier (FEI) is 3012640853.

Can shipments from Marcas Nestle SA de CV still enter the U.S.?

Shipments of nestle nido kinder milk based powder from Marcas Nestle SA de CV can be detained without physical examination under Import Alert 99-45; 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).