FDA 483 - Lanoue, Greg Farm - March 31, 2011

On March 30-31, 2011, the FDA inspected Greg Lanoue Farm, a shell egg producer located at 1892 330 Ave., Tracy, MN 56175 (FEI Number: 3002662136). The inspection, conducted by Christina A. Casti.oeyla and Traci C. Kelm, resulted in three observations.

Observation #1 noted a failure to maintain records documenting compliance with biosecurity measures. Specifically, the firm's biosecurity plan for protective clothing, good sanitation, keeping buildings free from stray poultry, pets, and wild animals, and employees' possession of birds at home lacked record-keeping to monitor employee compliance. Additionally, compliance with biosecurity measures for visitors was not documented in the Shell Egg (SE) plan.

Observation #2 identified inadequate monitoring methods for rodents. The firm's practices included weekly visual inspections and collection of (b)(4) stations, but lacked recorded counts or other documentation to determine acceptable or unacceptable activity levels.

Observation #3 cited similar issues with fly monitoring. Daily visual inspections were conducted, but counts or levels were not recorded or documented, preventing a determination of acceptable or unacceptable fly activity.