FDA EIR - Taylor Farms Tennessee, Inc. - October 28, 2022

The FDA conducted a comprehensive inspection of Taylor Farms Tennessee, Inc., a manufacturer and distributor of chopped fruits and vegetables and salad kits, from October 25 to October 28, 2022. This inspection was initiated following a positive Listeria monocytogenes test result in a cole slaw kit traced back to the facility. The regulatory framework for the inspection adhered to 21 CFR Part 117, focusing on Current Good Manufacturing Practice (CGMP) and preventive controls for human foods. The primary violation identified during the current inspection, leading to a Form FDA-483, was that the facility's design did not adequately facilitate maintenance and sanitary operations. Specifically, investigators observed condensate actively dripping from cooling units and ceiling beams in production areas, with personnel continually using mops to manage the issue. Environmental monitoring records also showed approximately 20 positive Listeria results in the 30 days prior to the inspection from various critical zones within the facility. This followed a previous inspection in November 2021 which cited deficiencies including failure to identify foreseeable hazards, lack of process control verification records, and inadequate cleaning and sanitization. For the current observation, management acknowledged the deficiency and was required to submit a written response to the FDA within 15 days of the inspection's conclusion. The correction status remains "Not Corrected," indicating ongoing need for resolution.