FDA WARNING_LETTER - El Guanaco Bakery & Cafe - March 04, 2011

The FDA conducted multiple inspections of El Guanaco Bakery & Café in St. Paul, Minnesota, between January and March 2011. The inspections revealed that several products, including Empanada De Piña, Empanada De Leche, Pastel-D, Galleta De Naranja, and pan de feria, were adulterated or misbranded under the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Adulteration (Section 402(c)):** Empanada De Piña, Pastel-D, and Galleta De Naranja contain unsafe color additive FD&C Yellow No. 5, which is not declared on the labels as required by 21 CFR 74.705(d)(2). 2. **Misbranding (Section 403(k)):** These products are misbranded because they contain artificial coloring (Yellow 5) that is not declared in the ingredient statements, as per 21 CFR 101.22(k). Additionally, Galleta De Naranja uses an ingredient containing Yellow 5 that is not listed. 3. **Misbranding (Section 403(w) - Allergens):** Galleta De Naranja and Empanada De Piña fail to declare major food allergens (egg, soy) completely or accurately. Empanada De Piña contains egg wash, and Galleta De Naranja contains