FDA 483 - Nugent Nuggets, LLC - May 10, 2011

Nugent Nuggets, LLC received an FDA Form 483 following an inspection conducted from May 9-10, 2011, at its shell egg production facility in Radcliffe, IA. The inspection revealed several deficiencies in the company's adherence to its written Salmonella Enteritidis (SE) prevention plan and general record-keeping practices.

Key observations included a failure to fully implement the SE prevention plan. Specifically, layer barns were not cleaned and disinfected between flocks as per company policy. Biosecurity measures were also found inadequate, lacking controlled gates, warning signs, secured entrances, and intercommunication devices at the farm entrance.

Regarding SE detection, the firm did not utilize an FDA-recognized environmental sampling method, instead employing commercially available test kits deemed non-equivalent. The sampling plan itself was also inappropriate, as it did not adequately cover all areas of the poultry houses, such as upper-level walkways and specific tiers.

Furthermore, rodent monitoring was deficient, with no "Barn Rodent Index" calculation being performed. Various critical records, including the Mice Log, Layer Records, and other procedural documents, were incomplete, lacking details such as activity times, the year of activity, and the firm's name and location. Finally, the written SE prevention plan itself lacked the required signatures or initials of the administrators.

These observations highlight the need for Nugent Nuggets, LLC to implement comprehensive corrective actions to ensure full compliance with its established SE prevention protocols and federal regulations governing shell egg safety.