FDA 483 - Setton Pistachio of Terra Bella, Inc. - April 30, 2009

An FDA 483 inspection, detailing issues observed between October 2008 and March 2009, cited the firm for significant failures in manufacturing, packaging, and storing food under conditions necessary to prevent microbial growth and contamination. The firm continued to process and distribute roasted pistachio products that tested positive for Salmonella, initially identified in October 2008, without adequately evaluating its roasting process or investigating potential cross-contamination routes. This included re-roasting and blending Salmonella-positive product into other batches. Key violations included a lack of adequate controls to ensure the roasting process effectively destroyed pathogens, with no consistent monitoring of temperatures, time, or product depth, and uncalibrated equipment. Facility design was deficient, lacking an effective air flow system to prevent cross-contamination between raw and finished products. Operations further exacerbated risks, as raw and roasted pistachios were handled in the same rooms, on shared equipment without proper cleaning protocols, and employees and equipment moved freely between areas, increasing the risk of contamination. Additionally, equipment maintenance was poor; cleaned conveyor buckets were stored outdoors exposed to the environment, and certain equipment had uncleanable components or accumulated dust. These observations indicate a systemic breakdown in the firm's food safety management system, necessitating immediate and comprehensive corrective actions to validate processes, prevent cross-contamination, and ensure the sanitary production of its products, aligning with FDA food safety requirements.