FDA WARNING_LETTER - Almark Foods Inc - February 13, 2019

The FDA inspected a ready-to-eat (RTE) hard-boiled egg processing facility in Gainesville, GA, from February 5-13, 2019. Environmental samples collected during the inspection tested positive for *Listeria monocytogenes* (L. mono), a human pathogen, in the peeling room. Whole Genome Sequencing (WGS) analysis confirmed two genetically identical L. mono isolates, suggesting cross-contamination and linking them to two human illness cases from 2017.

This indicates the facility's sanitation efforts are inadequate to control pathogens, rendering food products adulterated under 21 U.S.C. §342(a)(4). Significant violations of Current Good Manufacturing Practice (CGMP) and Preventive Controls for Human Food (PCHF) rules were noted. Additionally, FDA investigators observed buckets of salad eggs stored unattended at ambient temperatures for at least three hours daily in the peeling room. A provided preservative study was deemed inadequate to validate pathogen elimination under processing conditions. The firm's thermometer calibration method using ice water was also deemed inappropriate for temperatures closer to boiling.

The company had submitted responses to the FDA Form 483 and L. mono findings, and initiated product recalls and a study. The FDA requires a written response within fifteen working days detailing corrective actions, timelines, and supporting documentation. Failure to comply may result in re-inspection fees.