FDA 483 - Guthrie Center Egg Farm - April 05, 2011

During an FDA inspection conducted on April 4-5, 2011, Rose Acre Farms, Inc.'s Guthrie Center facility received a Form 483 for several observations related to their shell egg production. The inspection revealed that the company's written Salmonella Enteritidis (SE) prevention plan was not fully implemented. Specifically, the firm failed to notify the Iowa State Veterinarian about a diagnosed case of Marek's Virus in their hens, despite their Biosecurity Plan requiring such notification for reportable infectious poultry diseases. Additionally, the facility's method for environmental sampling to detect SE was not consistent with the FDA's specified method or an equivalent, failing to comply with 21 CFR 118.8(a). Finally, a review of required records for September through November 2010, such as IPM Form C, showed a lack of signatures or initials from the individuals performing the operations or creating these records. Rose Acre Farms is expected to address these findings and implement corrective actions to ensure adherence to regulatory standards and their own established procedures.