FDA 483 - WR Cramer - March 24, 2011

During an inspection conducted from March 22-24, 2011, the FDA identified significant issues at WR Cramer, a shell egg producer in Perris, CA. The inspection revealed six key observations related to the company's compliance with Salmonella Enteritidis (SE) prevention regulations. A primary concern was the inadequacy of WR Cramer's written SE prevention plan, which lacked essential measures. These included protocols for procuring SE-monitored pullets, ensuring eggs are held at or below 45 degrees F within 36 hours of lay, preventing cross-contamination by equipment and personnel, prohibiting employee bird ownership, and outlining cleaning/disinfection procedures after an SE positive test. Furthermore, the existing plan was not fully implemented, as evidenced by observed rodents and wild birds in poultry houses, and a lack of pest control records despite pests being present. Structural deficiencies, such as holes and gaps in poultry houses, allowed animal entry. Additionally, there was no documentation that eggs were consistently held at or below 45 degrees F after 36 hours post-lay, and the SE prevention plan itself was not properly signed by the individuals responsible for its administration. WR Cramer is required to address these observations to achieve compliance with food safety standards.