FDA 483 - Lloyd Brubacker - June 10, 2011

This FDA Form 483 document outlines observations made during an inspection related to a shell egg production facility. The primary issues identified concern the implementation and maintenance of the *Salmonella Enteritidis* (SE) prevention plan.

Specifically, the facility's written SE prevention plan was not fully implemented and followed. The plan stated that Mr. Lloyd Brubacker, Owner/SE Plan Administrator, would place bait in the manure pit, but he stated he does not, and no bait was observed during a walkthrough. Rodent monitoring records did not reflect the frequency stated in the SE prevention plan; for example, monitoring occurred on 10/26/10 and not again until 11/19/10.

Furthermore, the firm lacked a written SE prevention plan specific to the farm where eggs are produced. From 07/09/10 to 03/29/11, the firm did not implement an SE prevention plan while producing shell eggs for the table market; the current plan on file is dated 03/30/11. Lastly, the firm failed to maintain records documenting compliance with rodent and other pest control measures, specifically failing to implement fly monitoring from 07/09/10 to 08/17/10 and again from 08/17/10 to 09/05/10.