FDA WARNING_LETTER - Sparboe Farms / Prairie Complex - July 22, 2011

The FDA issued a Warning Letter to Sparboe Farms, Inc. / Prairie Complex following inspections of five shell egg production facilities between April and July 2011. The inspections revealed serious violations of the Prevention of Salmonella Enteritidis (SE) in Shell Eggs During Production, Storage, and Transportation regulation (21 CFR Part 118), rendering their shell eggs adulterated under the FFD&C Act and in violation of the PHS Act.

Key violations included: 1. **Lack of Farm-Specific SE Prevention Plans:** Written SE prevention plans were not specific to each of the five inspected farms. 2. **Failure to Test After Molting:** Environmental testing for SE was not performed in a poultry house (Litchfield, MN) four to six weeks after a molting process, and no records were provided to demonstrate such testing. 3. **Inadequate Rodent Control:** Despite monitoring indicating unacceptable rodent activity at Goodell, Litchfield, Humboldt, and Britt facilities, appropriate remedial actions were not taken. The firm's attempts to change rodent index thresholds to reflect historical levels were deemed unacceptable. 4. **Failure to Remove Pest Harborage:** Vegetation and debris (lumber pile, tall grass) that could harbor pests were observed outside a poultry house at Britt, IA. 5. **Inadequate Fly Control:** Written SE prevention plans lacked appropriate fly monitoring methods, and satisfactory fly control was not achieved when monitoring indicated unacceptable