FDA 483 - Norco Ranch - E&M Ranch - February 24, 2011

This FDA Form 483 documents observations from an inspection concerning the production of table eggs. Two primary violations were identified.

Firstly, eggs intended for table egg processing were not held and transported at or below 45°F as required. Specifically, the firm's *Salmonella Enteritidis* (SE) prevention plan lacked a critical prevention measure: ensuring eggs are refrigerated within 36 hours after lay.

Secondly, the firm failed to implement appropriate methods for satisfactory rodent control when monitoring indicated unacceptable rodent activity within poultry houses. The firm's "Weekly Rodent Monitoring Record (Rats)" established a rodent index of 0.8. However, the firm continuously exceeded this established limit for rats/activity in bait stations across all 10 poultry houses. Detailed dates of exceedance were provided for each poultry house, spanning from July 2010 to February 2011, indicating a persistent and widespread issue with rodent control. These findings suggest deficiencies in the firm's quality system and manufacturing controls related to environmental monitoring and pest management, potentially impacting product safety.