FDA WARNING_LETTER - Bradley Industries, Inc. - June 13, 2012

An FDA inspection of Bradley Industries, Inc.'s manufacturing facility in Milwaukee, Wisconsin, on June 5, 12-13, 2012, revealed significant deviations from food labeling regulations (21 CFR Part 101). These violations cause their Stoneridge pasta products to be adulterated under section 402 and misbranded under section 403 of the Federal Food, Drug, and Cosmetic Act (the Act).

Specific violations include: 1. **Adulteration (Section 402(a)(2)(C)):** Stoneridge pasta products (Gourmet Fettuccine, Tri-Color Fettuccine, Basil & Tomato Linguine, Spinach Fettuccine, Garlic & Basil Pesto Linguine) are made from semolina enriched with folic acid. Folic acid is not permitted in semolina flour per 21 CFR 172.345(c), making it an unsafe food additive. 2. **Misbranding - Allergen Declaration (Section 403(w)):** The labels for the aforementioned pasta products fail to declare wheat, a major food allergen, despite containing "100% Durum Semolina Flour Enriched" or "100% Organic Durum Flour." Labels must declare major food allergens as specified in Section 403(w)(1)(A) or (B) of the Act. 3. **Mis