FDA 483 - L & W Farms, LLC - April 12, 2011

This FDA Form 483 document outlines observations from an inspection of a shell egg production facility. The primary issues identified relate to the firm's Salmonella Enteritidis (SE) prevention plan and egg storage temperatures.

Specifically, the firm lacked a written SE prevention plan tailored to the specific farm producing eggs, and did not implement any SE prevention plan while producing shell eggs for the table market from July 9, 2010, to March 22, 2011. A current SE prevention plan was only on file as of March 23, 2011. Furthermore, the written SE prevention plan was not fully implemented, as evidenced by the failure to conduct fly monitoring using a redacted method from July 9, 2010, to December 21, 2010.

Additionally, the facility failed to maintain shell eggs at or below 45°F beginning 36 hours after the time of lay. The ambient temperature of the refrigeration unit used for shell egg storage exceeded 45°F on multiple dates: September 1, 2010 (48°F), September 18, 2010 (48°F), October 1, 2010 (46°F), November 8, 2010 (50°F), November 16, 2010 (47°F),