FDA WARNING_LETTER - NP Foods Ltd., Starburadze Production Facility - July 17, 2014

On July 17, 2014, the FDA inspected NP Foods Ltd.'s facility, Agrovillaserra S.L., in Spain, finding violations of the Federal Food, Drug, and Cosmetic Act and 21 CFR Part 101 for Laima Classic Wafer Cake With Crumbled Hazelnuts (8.82 oz. and 17.64 oz.) and Laima Selga Classic Biscuit products.

The products are misbranded under Section 403(q) due to incorrect nutrition information format (21 CFR 101.9). Specific issues for Laima Selga Classic Biscuit include failure to declare servings per container (101.9(b)(8), 101.9(d)(3)(ii)), incorrect calorie declaration (101.9(c)(1)), failure to declare calories from fat (101.9(c)(1)(ii)), cholesterol (101.9(c)(3)), Vitamin A, C, Calcium, Iron (101.9(d)(8)), and dietary fiber (101.9(c)(6)(i)). All three products failed to declare Trans-fat (101.9(c)(2)(ii)).

Laima Selga Classic Biscuit is also misbranded under Section 403(i)(1) for lacking an English statement of identity on the principal