Salazones Garre, S.L. – FDA Warning Letter, May 6, 2014

The FDA inspected Salazones Garre, S.L. in San Pedro Del Pinatar, Spain, on May 5-6, 2014, to assess compliance with the Federal Food, Drug, and Cosmetic Act. The inspection found the "Garre Salazones y Ahymados Mojama Extra Loins Air Dried Yellowfin Tuna" product to be misbranded under 21 CFR Part 101.

Key violations include: 1. **Misbranding (Section 403(q)):** The nutrition information on the product label is incorrect. This includes: * Failure to declare serving size based on the 30g RACC for dried fish and in common household measure (declared 100g). * Failure to declare servings per container. * Calories expressed in kcal, not in accordance with regulations. * Failure to declare required nutrients: Calories from fat, Saturated fat, Trans-fat, Cholesterol, Sodium, Total carbohydrates, Dietary fiber, and Sugars. * Failure to declare percent daily values. * Failure to provide percent daily value of protein for the "High in protein content" claim. * Inclusion of nutrient content claims and Omega 3-6 statements within the Nutrition Facts panel.

2. **Misbranding (Section 403(f)):** The label contains information in both