bakery project inc. – FDA Warning Letter, Aug 1, 2013

On July 31-August 1, 2013, the Kansas Department of Agriculture, on behalf of the FDA, inspected Bakery Project, Inc. in Wichita, Kansas. The inspection revealed significant violations of FDA's Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 110), causing the manufactured foods to be adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations included: 1. **Pest Infestation (21 CFR 110.35(c)):** Observed flies on dough, live beetles on equipment, roaches on glue boards, and insect tracking/webbing throughout the facility. 2. **Facility Maintenance (21 CFR 110.20(b)(4)):** Two holes in the ceiling were leaking water, one onto packaged product. 3. **Cleaning of Food-Contact Surfaces (21 CFR 110.35(d)):** Buildup of dried food debris and old dough on scale pans, measuring cups, dividers, and mixer belts. 4. **Pest Protection (21 CFR 110.20(b)(7)):** Holes in screen doors and unscreened holes in walls were observed. 5. **Equipment Design and Maintenance (21 CFR 110.40(a)):** A cracked food