FDA WARNING_LETTER - Jonathan S. Allgyer - September 26, 2013

The FDA inspected Jonathan S. Allgyer's shell egg production facility in Shullsburg, Wisconsin, on September 23 and 26, 2013, revealing serious violations of the Prevention of Salmonella Enteritidis (SE) in Shell Eggs regulation (21 CFR 118). These failures render the shell eggs adulterated under the FD&C Act and in violation of the PHS Act. Significant deficiencies include the failure to fully implement the written SE prevention plan, specifically regarding environmental SE testing at the correct flock age (40-45 weeks), inadequate biosecurity measures allowing unauthorized visitors without protective gear, and insufficient weekly pest control monitoring for rodents and flies. The firm also failed to maintain vegetation around poultry houses as specified in their plan. Further violations involved inadequate record-keeping for environmental sampling procedures and SE test results, the SE prevention plan administrator's failure to sign and date the plan, and the use of an inappropriate environmental sampling plan with insufficient swabs for the poultry house layout. Additionally, the SE prevention plan itself lacked required details for pest control monitoring and control methods. The FDA requires prompt corrective action, with a written response outlining specific steps and supporting documentation within 15 working days, warning that failure to comply may lead to regulatory actions such as seizure or injunction.