FDA 483 - Willamette Egg Farms LLC - May 06, 2011

An FDA inspection conducted on May 5-6, 2011, at Willamette Egg Farms LLC in Canby, OR, identified significant deficiencies in the company's *Salmonella Enteritidis* (SE) prevention plan. The inspection revealed that the existing "Willamette Egg Farms Shell Egg Quality Assurance Plan," in use from July 9, 2010, to April 24, 2011, did not include several critical SE prevention measures. These missing elements comprised environmental testing for SE in pullets (14-16 weeks of age) and laying hens (40-45 weeks of age), robust biosecurity procedures, monitoring and documentation for flies and other non-rodent pests, and comprehensive refrigeration monitoring and documentation. Furthermore, both the older plan and a newer "Willamette Egg Farms Egg Quality Assurance and SE Prevention Plan," dated April 25, 2011, were found to lack site-specific details for "Nest Fresh Farm." These observations indicate a failure to adequately address the regulatory requirements for preventing SE contamination in shell eggs, consistent with FDA guidelines for egg processors. Willamette Egg Farms LLC is required to revise and implement a comprehensive and site-specific SE prevention plan to rectify these identified issues, ensuring proper testing, biosecurity, pest control, and refrigeration practices are documented and followed to protect public health.