FDA WARNING_LETTER - Willow Farms - April 18, 2013

The FDA inspected Willow Farms, a shell egg production facility, on April 16-18, 2013, and found serious violations of the Prevention of Salmonella Enteritidis (SE) in Shell Eggs regulation (21 CFR Part 118). These violations render shell eggs adulterated under Section 402(a)(4) of the FD&C Act and in violation of Section 361(a) of the PHS Act. Environmental samples from House #4 tested positive for SE, leading to the voluntary destruction of the flock and eggs. The firm's SE prevention plan was deficient, lacking required measures for pullet monitoring, biosecurity (visitor limits, cross-contamination prevention, animal exclusion), rodent and fly monitoring, and cleaning/disinfection after SE positive tests. The firm also failed to maintain records for pullet monitoring and biosecurity, and did not perform required environmental testing for SE when hens were 40-45 weeks of age. Furthermore, the firm failed to fully implement its plan, specifically regarding refrigeration temperature monitoring and using an unrefrigerated delivery van. Willow Farms must correct these violations promptly, submit a revised SE prevention plan and documentation within 15 working days, or face regulatory actions such as seizure or injunction, and potential re-inspection fees.