Miller's Bakery, inc. – FDA Warning Letter, Mar 6, 2008

An FDA inspection of Miller's Bakery, Inc. (1415 N. Fifth Street, Milwaukee, Wisconsin) was conducted on December 20, 2007, January 22, 24, and March 3 and 6, 2008, verifying the firm manufactures and distributes bakery products. The inspection revealed misbranding violations under section 403 of the Federal Food, Drug and Cosmetic Act (the Act) [21 U.S.C. 343] for Miller Bakery Stollen, Seedless Rye Bread, and Knot Dinner Rolls.

Specific violations include: 1. **Miller Bakery Stollen** is misbranded under section 403(w) of the Act [21 U.S.C. 343(w)] because its label fails to declare wheat, a major food allergen, despite containing bleached enriched bromated flour (which contains wheat flour). 2. **Miller Bakery Stollen, Seedless Rye Bread, and Knot Dinner Rolls** are misbranded under section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] because their labels fail to list all sub-ingredients. Examples include "unbleached enriched flour" in Stollen, Seedless Rye Bread, and Knot Dinner Rolls, and "shortening" and "margarine" in St