FDA 483 - Arkansas Egg Company-Thomas Farms - April 04, 2011

This FDA Form 483 details observations from an inspection at Thomas Farm. The primary issues involve data integrity and non-compliance with the firm's Salmonella Enteritidis (SE) prevention plan.

Regarding data integrity, refrigeration logs at Thomas Farm for July 2010 through March 2011 do not accurately reflect cooler temperatures and times. The logs, written in pencil, show erased entries with higher temperatures (e.g., 50°F and above) beneath currently recorded lower temperatures (e.g., 41°F). A farm handler admitted to erasing and re-recording temperatures multiple times daily, only retaining the last daily reading. Examples include erased readings of 56.3°F (July 29, 2010), 55.4°F (August 24, 2010), 56.3°F (September 11, 2010), and 52.0°F (October 22, 2011). No review or corrective action was taken for these record alterations.

The SE prevention plan was not fully implemented. The plan requires environmental samples (drag swabs) to be taken between 40-45 weeks of age, with one swab per 8 feet of house length. For the 481-foot hen houses, 61 swabs are required (481/8 rounded