FDA EIR - Sunrise Farms, LLC- Bodega Ranch - May 05, 2011

An FDA inspection of Sunrise Farms, LLC- Bodega Ranch, a shell egg producer in Petaluma, CA, was conducted from May 3 to May 5, 2011. This was the firm's first FDA inspection, focusing on their Salmonella Enteritidis (SE) prevention plan and compliance with the Egg Safety Rule (21 CFR 118). Investigators reviewed the firm's biosecurity measures, pullet rearing practices, pest control programs for flies and rodents, cleaning and disinfection procedures, environmental sampling, and refrigeration protocols.

The inspection concluded without issuing a Form FDA 483, indicating no significant objectionable conditions were observed. However, a key area of discussion with management concerned record-keeping requirements. Specifically, the firm was reminded that all records related to the SE prevention plan must include the signature or initials of the person recording the information, along with the time and date of the action, as mandated by 21 CFR 118.10(b). Management, which was highly cooperative throughout the inspection, pledged to implement immediate corrections to address this administrative deficiency. No public health concerns or refusals were encountered, and no samples were collected during the inspection.