FDA 483 - Fremont Farms, L.C. - June 29, 2011

The FDA Form 483 details multiple violations at a poultry facility. On September 29, 2010, House 1 tested positive for Salmonella Enteritidis (SE). However, the cleaning record for House 1 (June 9-15, 2011) did not indicate manure removal, confirmed by management, before new SE-clean birds were introduced on June 17, 2011.

Environmental testing for SE was not conducted in House 2 when the flock was 40-45 weeks old; testing occurred at 46 weeks. The firm's environmental sampling plan was deemed inappropriate as it did not sample egg belts and the schematic was not representative of the entire house, which contains multiple rows of caged chickens. The firm also used an unapproved method for SE environmental testing, specifically "redacted," which is not recognized by the FDA as equivalent.

The written SE prevention plan was deficient, lacking measures for preventing cross-contamination when equipment or personnel move between houses, and for preventing stray poultry, wild birds, cats, and other animals from entering houses. The pest control policy failed to include removal of debris inside and outside poultry houses. The cleaning and disinfection policy did not mandate removal of all visible manure after an SE positive test.

Furthermore, the SE prevention plan was not fully implemented. Fly monitoring records for 2011 were missing in 5 out of 20 instances.