FDA 483 - Kellen Egg Farm - June 22, 2011

The FDA issued a Form 483 to Kellen Egg Farm following an inspection on June 20, 2011, citing significant deviations from their written Salmonella Enteritidis (SE) Prevention Plan. The primary observations indicated a failure to fully implement and follow the established plan. Specifically, the inspection revealed inadequate pest control measures across both Barn 1 and Barn 2. Observations included multiple burrow holes, gaps in doors, nesting materials, a dead mouse, two dead rats, and a live bird within the barn structures. These findings directly contradicted the farm's plan, which requires measures like closing access holes and removing varmints to protect birds. Furthermore, the farm failed to maintain effective rodent control. Despite a Rodent Index (RI) consistently exceeding the established threshold of one in both barns over various periods, no corrective actions were taken as required by their plan to reduce rodent populations. Finally, the inspection noted a deviation in egg removal procedures. The SE Plan mandates daily egg removal, but the farm's practice was to accumulate a certain number of pallets over several days before removal, contrary to their own documented procedures. These observations highlight the need for Kellen Egg Farm to promptly implement and strictly adhere to all components of its SE Prevention Plan to ensure compliance with food safety regulations concerning shell eggs.