FDA WARNING_LETTER - Elmer Yoder - September 12, 2013

The FDA inspected Elmer Yoder's shell egg production facility from September 10-12, 2013, identifying significant violations of the Prevention of Salmonella Enteritidis (SE) in Shell Eggs regulation (21 CFR Part 118). These deficiencies render the firm's shell eggs adulterated under the FD&C Act and in violation of the PHS Act. Key violations included the failure to prevent wild birds from entering the poultry house (21 CFR 118.4(b)(4)) and an inadequate written SE prevention plan that did not address all required prevention measures (21 CFR 118.4). The firm also failed to fully implement its SE prevention plan, evidenced by undocumented rodent and fly monitoring and a lack of corrective actions for high rodent indices. Additionally, records documenting rodent and pest control measures were not maintained as required (21 CFR 118.10(a)(3)(ii)). The FDA also noted concerns about temporary help potentially introducing SE. Elmer Yoder is required to take prompt corrective action and respond in writing within fifteen working days, detailing steps taken to correct violations and prevent recurrence, with potential regulatory action for non-compliance.