FDA 483 - Cal-Maine Foods Inc. - June 17, 2011

During an FDA inspection conducted from June 16-17, 2011, at Cal-Maine Foods Inc., an egg shell producer located in Harwood, TX, several significant observations were noted regarding pest control and facility maintenance. The inspection revealed conditions that could create potential harborages for pests, a concern under regulatory guidelines for egg production facilities, likely referencing the company's Salmonella Enteritidis (SE) prevention plan. Specifically, inspectors observed numerous cow manure piles positioned approximately three feet from Poultry House #18, with another pile found between Houses #15 and #16. These accumulations violated the company's own SE plan requirement for debris removal within 50 feet of all layer houses. Furthermore, a dripping cool cell pad on the north side of House #14 led to a substantial pooling of water, measuring about ten feet by five feet, immediately adjacent to the building. On the south side of House #15, a cool block designed to recirculate wastewater was found leaking into a ten-foot-long, one-foot-wide rut created by a tractor tire in the ground. These observations highlight deficiencies in maintaining the external environment around poultry houses, which could attract pests and compromise biosecurity. As is standard for an FDA Form 483, these are preliminary inspectional observations, not a final determination of compliance. Cal-Maine Foods Inc. is expected to address these issues by implementing corrective actions and can discuss their plans or objections with the FDA.