FDA 483 - Sparboe Farms Inc. - April 29, 2011

This FDA Form 483 document details observations from an inspection of Sparboe Farms, focusing on their egg production and Salmonella Enteritidis (SE) prevention programs. The inspection revealed several deficiencies in their practices and documentation.

A key issue is the lack of adequate cross-contamination prevention. Employees move between SE-positive and SE-negative poultry houses without sufficient precautions, and the Biosecurity Program and Procedures Manual (version #4, September 2009) and Salmonella Prevention Program SOP.OPS.PRD.7 fail to address this personnel movement.

Regarding SE testing, the firm's SOP.OPS.PRD.7 (Revised 04/1/2011) specifies the use of commercially available (b)(4) for environmental sampling, which is not recognized as an equivalent method to the FDA's "Environmental Sampling and Detection of Salmonella in Poultry Houses." Furthermore, the environmental sampling plan is inadequate, as it only samples (b)(4) egg belts from (b)(4) sides, neglecting (b)(4) tiers and (b)(4) walkways, which are not sampled.

Observations also noted failures in preventing stray animals, with a wild bird observed in House (b)(4), and damaged bird netting and broken louvers on ventilation fans in House (b)(4). Rodent control is insufficient; the barn rodent index consistently exceeded the acceptable limit of 0.5 over the past 10 months.