FDA WARNING_LETTER - Global Bakery Corporation - June 14, 2011

The FDA conducted an inspection of Global Bakery Corporation's facility in Fajardo, Puerto Rico, from June 1-14, 2011. The inspection revealed that the firm's Mini Turnover Piña, Guayaba Turnover, and Italian Cookies Rainbow products are misbranded under the Federal Food, Drug, and Cosmetic Act (the Act) due to labeling violations.

Key violations include: 1. **Misbranding under 403(q) (Nutrition Information):** * Labels claim "0 Trans Fat" but fail to declare polyunsaturated and monounsaturated fat. * Mini Turnover Piña's serving size is incorrectly declared as "1 (1.20oz)(33.5g)" instead of 4 units, based on the Reference Amount Customarily Consumed (RACC) of 125g for turnovers. * Italian Cookies Rainbow's serving size is declared as "8-10" instead of a rounded whole number with "about."

2. **Misbranding under 403(i)(2) (Ingredient Declaration):** * Failure to declare sub-ingredients: agar and artificial color in Mini Turnover Piña's pineapple filling; sodium benzoate in Guayaba Turnover's guava filling; and sub-ingredients of enriched wheat flour and rainbow candy bits in Italian Cookies Rainbow. * Incorrect declaration of "pot