FDA WARNING_LETTER - D.A.Y. Farm - July 18, 2019

The FDA inspected a shell egg farm at 13007 Keller Drive, Saint Charles, Minnesota, on July 15, 16, and 18, 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 shell eggs adulterated under the Federal Food, Drug, and Cosmetic Act and in violation of the Public Health Service Act. Key deficiencies included the firm's failure to implement a written Salmonella Enteritidis prevention plan (SE Plan) as required by 21 CFR 118.4, specifically lacking measures for pullet procurement, biosecurity, pest control, cleaning, disinfecting, and proper egg refrigeration. The firm also failed to hold and transport eggs at or below 45°F (21 CFR 118.4(e)), maintain continuous refrigeration records (21 CFR 118.10(a)(3)(iv)), and record exact temperatures (21 CFR 118.10(b)(4)). Additionally, the firm did not conduct environmental SE testing in the poultry house at 40-45 weeks of age (21 CFR 118.5(a)) and lacked documentation for procuring SE-monitored pullets (21 CFR 118.4(a)(2), 118.10(a)(2)). The FDA deemed the firm's July 30, 2019, response inadequate for several violations. The firm must promptly correct all cited issues and submit a written response within 15 working days detailing corrective actions and timelines. Failure to comply may result in regulatory actions like seizure or injunction, with FDA verifying compliance during a subsequent inspection.