FDA 483 - Sparboe Farms, Inc - Humboldt Feed Mill - June 21, 2011

An FDA inspection conducted on June 20-21, 2011, at Humboldt Egg Farms in Humboldt, IA, identified significant deviations from regulatory requirements regarding Salmonella Enteritidis (SE) prevention. The inspection, conducted under the framework of shell egg production regulations, revealed that the company's written SE prevention plan was not fully implemented or consistently followed.

Key issues observed included a failure to monitor rodent activity per individual barn, instead using a facility-wide approach, and an inadequate rodent index threshold, both contrary to FDA Industry Guidance. Furthermore, when unacceptable rodent levels were detected in several poultry houses, no documented corrective actions were taken. The company's SE prevention plan also lacked appropriate measures, specifying pullet testing at 12 weeks rather than the required 14-16 weeks, and indeed, some pullets were not tested at all, or tested too early. The methods used for environmental SE sample testing were not recognized as equivalent to FDA-approved procedures. Finally, essential records, specifically Rodent Monitoring Records, lacked the signatures or initials of the individuals performing the monitoring, indicating a lapse in record-keeping compliance.

To address these observations, Humboldt Egg Farms is required to revise and fully implement its SE prevention plan, ensuring proper rodent control, accurate pullet testing schedules and methods, and compliant environmental testing protocols. All corrective actions must be documented, and records must be properly signed and maintained according to regulatory standards.