FDA WARNING_LETTER - Bakery Project Inc. dba Delano Bakery - August 27, 2021

The FDA inspected a manufacturing facility at 1025 W. 29th St. N, Wichita, Kansas, from August 3-27, 2021, and found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (21 CFR Part 117). Sample INV1133078 confirmed pests, including live and dead cockroaches, moths, insect webbing, a moth larva, and rodent excreta. This led to the determination that ready-to-eat (RTE) bread products were adulterated under 21 U.S.C. § 342(a)(4) due to insanitary conditions.

Significant violations included: 1. **Pest Contamination (21 CFR 117.35(c)):** Numerous live and dead insects (cockroaches, moths, beetles, larvae) and rodent droppings were found throughout the facility, including in proofers, on equipment, and near ingredients. Open doors and damaged screening contributed to pest entry. 2. **Inadequate Equipment Cleaning and Sanitizing (21 CFR 117.80(c)(1)):** Heavily soiled oven mitts, food residue/dust on bread racks, dirty dough totes, dried food residue on mixers and molders, and a chipped wooden pizza peel were observed. Allergen cross-contact was a