FDA 483 - Sparboe Farms Inc. - May 19, 2011

This FDA Form 483 document outlines observations from an inspection related to Salmonella Enteritidis (SE) prevention and record-keeping practices. The facility's Salmonella Prevention Program, SOP.OPS.PRD 8, revised on May 16, 2011, was found deficient as it "lacks appropriate SE prevention measures." Specifically, it "does not include cross contamination practices when persons or equipment move between poultry houses without Flock Isolation."

Additionally, the inspection identified deficiencies in required records. Documents titled "FLY Counts," "Sparboe Cooler Monitoring Log," and the "Fly Control log" failed to include the firm's name and location. These same documents also lacked the signature or initials of the person performing the operation or creating the record, which is a requirement for all such records. These observations indicate issues with the facility's quality system regarding SE prevention protocols and the completeness and traceability of operational records.