FDA WARNING_LETTER - Pamonharia do Aguinaldo Ltda. - March 20, 2015

The FDA inspected Pamonharia do Aguinaldo Ltda. in Patos de Minas, Brazil, on March 19-20, 2015, finding their Brazilian Corn Tamales (traditional salt and sweet mixtures) products in violation of the Federal Food, Drug, and Cosmetic Act and 21 CFR Part 101.

Key violations include: 1. **Misbranding (Allergen Declaration):** Products are misbranded under Section 403(w) of the Act because they contain "cheese" (which contains "milk") but fail to declare "milk" as a major food allergen on the labels. 2. **Misbranding (Nutrition Information Format):** Products are misbranded under Section 403(q) due to improper nutrition information format. Deficiencies include failure to declare serving size in common household measure, "Servings Per Container," calories in appropriate units (kcal used instead of calories), percent daily values for saturated fat and cholesterol, sugars, sodium and cholesterol in milligrams, and calories from fat. Additionally, saturated and trans fat amounts declared as "<1 g" are not permitted; they must be declared as zero if less than 0.5g. 3. **Misbranding (Ingredient Declaration):** Products are misbranded under Section 403(i)(2) because they fail to declare sub-ingredients for "cheese" as required by 21 CFR 1