FDA 483 - Fresh & Ready Foods LLC - April 15, 2025

An FDA inspection conducted at Fresh & Ready Foods LLC from March 31 to April 15, 2025, identified significant deficiencies in the company's food safety management systems, primarily under the framework of Current Good Manufacturing Practices and Preventive Controls for Human Food. The inspection revealed four key observations that require immediate attention. Firstly, the company failed to establish a sanitation preventive control for environmental pathogen recontamination in its Ready-To-Eat (RTE) sandwich production. This was evidenced by the detection of Listeria monocytogenes in multiple environmental samples taken from production room equipment like roller conveyors and slicers. Secondly, existing process preventive control and monitoring procedures were deemed inadequate. Specifically, missing metal lacing segments on conveyor belts were observed, and some RTE products did not pass through a metal detector as required, a repeat observation from a previous 2022 inspection. Thirdly, the firm's hazard analysis for RTE sandwiches was found incomplete, failing to identify critical hazards such as E. Coli, Salmonella, Listeria monocytogenes, and B. cereus in incoming lettuce. Furthermore, vendor approval documentation, including third-party audit reports and valid supplier certificates, was not adequately maintained. Finally, sanitation monitoring practices were insufficient, highlighted by a hose submerged in a bucket of water without a backflow prevention device. Fresh & Ready Foods LLC is required to implement comprehensive corrective actions to address these observations and ensure compliance with food safety regulations.