Postres de Aqui, Inc. – FDA Warning Letter, Apr 5, 2011

On September 8, 2011, the FDA issued a Warning Letter to Postres de Aquí, Inc. following an inspection from March 9-10 and April 4-5, 2011, at their Cataño, Puerto Rico facility. The inspection revealed significant violations of food labeling regulations (21 CFR Part 101), causing products to be adulterated under Section 402 and misbranded under Section 403 of the Federal Food, Drug, and Cosmetic Act.

Key violations include:

* **Adulterated Products:** * **Avena Sin Azúcar Anadida (Oatmeal without sugar added):** Adulterated due to unsafe food additive (aspartame) because the label failed to include the required "PHENYLKETONURICS: CONTAINS PHENYLALANINE" statement (21 CFR 172.804(d)(2)). * **Muffin de Guineo (Banana Muffin):** Adulterated due to unsafe color additive (FD&C Yellow No. 5) not declared in the ingredient list (21 CFR 74.705(d)(2)).

* **Misbranded Products:** * **Muffin de Guineo:** Misbranded for failing to declare artificial coloring (FD&C Yellow No. 5) (21 CFR