FDA WARNING_LETTER - Helados La Tapatia, Inc. - March 19, 2014

The FDA inspected Helados La Tapatia, Inc. from March 3-19, 2014, and found multiple violations. The Strawberry Ice Cream and Mango Ice Cream (1.75 QT) products were deemed adulterated under 21 U.S.C. § 342(c) for containing unsafe color additives, such as undeclared "red color" and improperly declared "yellow food colorings" (FD&C Yellow #5).

Several products, including Natural Creamy Fruit Bar All Natural Esquimal (3 OZ), Natural Creamy Fruit Bar All Natural Cookies 'N' Cream (3 OZ), Strawberry Ice Cream, and Mango Ice Cream, were misbranded under 21 U.S.C. § 343(k) for failing to declare artificial coloring or chemical preservatives (e.g., calcium sorbate) as required by 21 CFR 101.22(k) and (j).

Additionally, the Natural Creamy Fruit Bar All Natural Esquimal and Cookies 'N' Cream products were misbranded under 21 U.S.C. § 343(a)(1) due to false and misleading "Natural" and "All Natural" claims, as they contained synthetic ingredients like calcium sorbate, polysorbate 40, and artificial colors. The Strawberry Ice Cream label falsely declared "Natural Fresh Coconut," and the "Fruit Bar"