FDA WARNING_LETTER - Luoma Egg Ranch, Inc. - June 21, 2019

The FDA inspected a shell egg farm in Finlayson, Minnesota, from June 18-21, 2019, identifying serious violations of the Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation regulation (21 CFR Part 118). These failures render the firm's shell eggs adulterated and in violation of the PHS Act. Key deficiencies included failure to conduct environmental testing for hens at 40-45 weeks of age (21 CFR 118.S(a)), and failure to hold table eggs at or below 45°F beginning 36 hours after lay (21 CFR 118.4(e)). The firm also failed to use appropriate fly monitoring methods (21 CFR 118.4(c)(2)), had inadequate rodent monitoring records without defined thresholds, and did not remove debris that could harbor pests (21 CFR 118.4(c)(3)). Furthermore, the SE prevention plan lacked proper biosecurity measures for equipment and personnel movement between houses (21 CFR 118.4(b)(2) and (3)), and the firm failed to implement biosecurity practices to limit visitors (21 CFR 118.4(b)(1)). The firm's June 30, 2019, response was deemed inadequate, lacking documentation for retraining, clarity on repairs, or specific corrective actions. The FDA requires prompt corrective action and a written response within 15 working days, detailing steps taken and preventing recurrence, warning that failure to comply may lead to regulatory actions like seizure or injunction.