Old Mill Bread Company Inc – FDA Warning Letter, Sep 10, 2014

On September 3, 8, and 10, 2014, the FDA inspected a bakery at 1102 NW 85th Street, Seattle, Washington, and found serious violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 110). The inspection revealed that food was adulterated under Section 402(a)(4) of the Federal Food, Drug and Cosmetic Act due to insanitary conditions.

Violations included: 1. **Pest Exclusion Failure (21 CFR 110.35(c)):** Live and dead beetle-like insects (red flour beetles, carpet beetles, Mediterranean flour moths) were found in the dough sheeter, dough mixer, and on the floor, contaminating exposed bread dough and flour. FDA analysis confirmed insect presence. 2. **Improper Equipment Handling (21 CFR 110.80(b)(7)):** Freshly baked bread was stored directly next to soiled cardboard, on used paper flour bags, and on heavily soiled metal racks. Plastic racks for finished products were stored on the production floor and outside on a public sidewalk. 3. **Improper Air-Blowing Equipment Operation (21 CFR 110.20(b)(6)):** Grimy floor fans blew air directly onto cooling bread, and a dusty, grimy ceiling ventilation duct was located above a baking