Zdenka d.d – FDA Warning Letter, Jul 8, 2014

The FDA inspected Zdenka d.d. in Veliki Zdenci, Croatia, from July 7-8, 2014, finding their cheese products (Zdenka SPORT dimljeni, Zdenka SPORT polutvrdi sir, and Zdenka SPORT polutvrdi sir trapist bez kore) in violation of the Federal Food, Drug, and Cosmetic Act and 21 CFR Part 101.

Key violations include: 1. **Misbranding (21 U.S.C. § 343(q) and 21 CFR 101.9):** Nutrition information is not provided as specified. Issues include incorrect serving size (not a "reference amount customarily consumed"), failure to declare serving size per container, trans-fat, calories from fat, cholesterol, Vitamin A, Vitamin C, Calcium, and iron. Caloric content is declared in Kcal or KJ, not in accordance with regulations. Specific products also failed to declare sugar, sodium, and saturated fat. 2. **Misbranding (21 U.S.C. § 343(f) and 21 CFR 101.15(c)(2)):** Products contain information in two languages but do not repeat all required label information (e.g., Nutrition Facts, statement of identity) in both languages. 3. **Misbranding (21 U.S.C. § 3