FDA 483 - Mahard Egg Farms, Inc - May 24, 2011

A U.S. Food and Drug Administration (FDA) inspection was conducted at Mahard Egg Farms, Inc., a shell egg producer in Sulphur, OK, from May 17-24, 2011. The inspection identified critical issues related to the company's Salmonella Enteritidis (SE) prevention program, which falls under FDA regulations for shell egg producers.

The primary violations included a lack of full implementation and adherence to the firm's written SE Prevention Plan. Specifically, environmental testing for SE was found to be inconsistent; for instance, an insufficient number of environmental drag swabs were collected for certain hen houses, and testing was conducted outside the required 40-45 week age window for laying hen flocks. These deviations were not documented, and no corrective actions were initiated to address these sampling errors. Furthermore, the company's Quality Egg Salmonella Enteritidis Prevention Plan, dated July 17, 2010, lacked the necessary signature and date from the plan administrator, indicating a significant procedural oversight.

As a result of these observations, Mahard Egg Farms, Inc. is required to address these deficiencies by reviewing and revising their SE prevention plan implementation to ensure strict adherence to testing protocols, proper documentation of deviations, and the timely implementation of effective corrective actions. The firm is expected to submit a comprehensive response to the FDA detailing its corrective measures.