FDA WARNING_LETTER - Grand Cakes Inc. - February 09, 2011

On July 15, 2011, the FDA issued a Warning Letter to Grand Cakes, Inc. following an inspection from January 24 to February 9, 2011, at their Bayamon, Puerto Rico facility. The inspection revealed multiple violations of FDA food labeling regulations (21 CFR Part 101), causing several "Kanelle Bizcocho de Canela y Nueces" products to be misbranded under Section 403 and adulterated under Section 402 of the Federal Food, Drug, and Cosmetic Act.

Key violations included: - **Adulteration due to unsafe food/color additives:** "Loaf Sugar Free" product contained aspartame but lacked the "PHENYLKETONURICS: CONTAINS PHENYLALANINE" statement (21 CFR 172.804(d)(2)). "Cup Cakes" and "Mini Cakes" contained undeclared FD&C Yellow No. 5 (21 CFR 74.705(d)(2)). - **Misbranding due to undeclared artificial ingredients:** Failure to declare artificial colorings (Yellow 5, Yellow 6, caramel color, Red 40, Blue 1) and artificial flavors in "Cup Cakes," "Mini Cakes," and "Mini Chocolate" products (21 CFR 101.22(k), 21 CFR 1