FDA EIR - Taylor Farms Tennessee, Inc. - November 23, 2021

An FDA inspection of Taylor Farms TN, Inc. in Smyrna, TN, was conducted from November 1 to November 23, 2021. The inspection, carried out under the Domestic Food Safety Compliance Program and regulatory frameworks like 21 CFR Part 117 (Current Good Manufacturing Practices and Preventive Controls for Human Food), identified significant issues. The inspection revealed three primary observations documented on an FDA Form 483. Firstly, the company's Food Safety Plan failed to identify a critical biological hazard: bacterial growth and/or toxin formation due to reduced oxygen packaging of fresh-cut produce. Secondly, there was a lack of adequate process control verification records, including insufficient documentation for the review of wash system performance and incomplete calibration records for critical pH and chlorine sensors. Lastly, sanitation practices were found deficient, specifically observing a sanitation employee placing a rinsing hose nozzle on a step stool and then the floor, and a failure to record disinfectant concentrations for floor treatments. Beyond the formal observations, discussions with management highlighted the need to document adherence to receiving Standard Operating Procedures and to verify that all incoming materials are sourced from approved suppliers. Management indicated plans to respond to the FDA Form 483. Promptly following the inspection, Taylor Farms initiated voluntary corrective actions, including improved documentation of wash system verification and consistent recording of disinfectant concentrations for foot foamers. The company was advised on compliance requirements and potential penalties for violations.