FDA 483 - New Horizon Cooperative - July 22, 2011

This FDA Form 483 details observations from an inspection of a poultry operation, citing multiple deficiencies in pest control and Salmonella Enteritidis (SE) prevention.

Regarding rodents, the facility failed to monitor their presence using appropriate methods, lacking justification for their rodent indexing (RI) system and action levels. Specific monitoring omissions occurred during the weeks of 7/13/10, 7/27/10, 8/24/10, 9/7/10, and 9/21/10. When unacceptable rodent activity was detected (e.g., RI over on 11/2/2010 for house 3), appropriate control methods were not implemented, despite management acknowledging a problem. The written SE prevention plan dated 7/1/2011 lacked the method for calculating RI.

For SE environmental testing, the facility did not use the "Environmental Sampling and Detection of Salmonella in Poultry Houses, most current edition" or an equivalent method. All prior environmental tests used a previous method without justification of its equivalence in accuracy, precision, and sensitivity.

The written SE prevention plan was not consistently implemented. The House Fly Activity Log lacked time recordings for 7/3/2011 and 7/10/2011, and the Fly Control Log lacked time and administrator initials for applications on 7/5/2011 and 7/2