FDA 483 - SSP America PHX, LLC - July 18, 2025

An FDA inspection conducted from July 15-18, 2025, identified significant food safety deficiencies at a ready-to-eat (RTE) food production facility, with observations addressed to Operations Manager Martin A. Block. The inspection revealed a critical failure to implement required preventive controls, as mandated by food safety regulations, specifically regarding the prevention of hazards in food for human consumption. The firm produces various RTE products, including fruit cups, sandwiches, and salads like Chopped Kale Salad. Despite identifying environmental monitoring as a sanitation preventive control for hand-packaged items, the company had not initiated planned swabbing activities by the inspection dates. Furthermore, significant gaps were noted in the supply chain preventive control program for ingredients such as vegetables and leafy greens. While the hazard analysis identified pathogenic bacteria like E. Coli, Salmonella, Listeria, and Clostridium B., and listed third-party audits and Certificates of Analysis (COAs) as verification methods, the firm admitted COAs were not used for controlling microbiological hazards during ingredient receiving. Additionally, supply chain controls were reportedly managed at a corporate level, raising concerns about effective plant-level implementation and verification. These observations highlight the need for the firm to promptly implement and verify its environmental monitoring program and establish robust, verifiable supply chain controls to ensure the safety of its food products and compliance with federal food safety requirements.