Due to both sanitation and environmental pathogenic contamination concerns, a manufacturer of RTE soft tortillas received an FDA warning letter citing sanitation SOP deviations, including lack of food-contact equipment disassembly (causing potential niche contamination), food residue on equipment after sanitation, and overspray on equipment from a high-pressure sanitation hose. Additional sanitary concerns included broken floors around drains; standing, pooling water; chipping paint; and employee traffic from raw to RTE areas.
FDA also had concerns with the facility’s Hazard Analysis and Risk-based Preventive Controls. It did not identify or control for a number of potential hazards, including recontamination of the tortillas with environmental pathogens prior to packaging (e.g., with Salmonella); mycotoxins in flour; and allergenic cross contamination. Although survival of pathogens at the baking step was considered, no process preventive control or baking process parameters were identified.
Identifying, evaluating, and controlling all potential hazards is not only required by regulation, it can help ensure against product contamination … and recall.
