FDA 483 - Esbenshade Enterprises - March 01, 2011

During an inspection conducted by the Food and Drug Administration (FDA) between February 25, 2011, and March 1, 2011, Esbenshade Enterprise, a shell egg producer in Ronks, PA, received a Form FDA 483 outlining significant observations. The primary issues identified related to the company's adherence to food safety regulations, specifically regarding the prevention of Salmonella Enteritidis (SE) and pest control. The inspection revealed two main violations. Firstly, Esbenshade Enterprise lacked a written SE prevention plan, a critical requirement for shell egg producers to mitigate the risk of SE contamination. Upon request, the owner confirmed the absence of such a plan. Secondly, the company failed to maintain adequate records documenting compliance with pest control measures. Specifically, fly control records were not kept from July 9, 2010, until February 14, 2011, indicating a lapse in documenting essential pest management activities. These observations highlight non-compliance with established regulatory frameworks designed to ensure the safety and quality of shell eggs. While an FDA 483 is an initial report and not a final determination, Esbenshade Enterprise is implicitly required to develop and implement a written SE prevention plan and establish robust record-keeping practices for all pest control measures to address these critical deficiencies and ensure regulatory compliance.