FDA WARNING_LETTER - Swan Brothers Dairy Inc - July 30, 2021

The FDA issued a Warning Letter to a ready-to-eat (RTE) cheese manufacturing facility in Claremore, Oklahoma, following an inspection from July 26-30, 2021. The inspection was prompted by a listeriosis hospitalization and death linked to the firm's raw milk, leading to a voluntary recall.

FDA analysis of environmental swabs found *Listeria monocytogenes* (L. monocytogenes) in the facility, specifically on a wooden piece under the capper stand of the filler machine. Whole genome sequencing (WGS) matched this environmental isolate to the clinical isolate from the deceased patient, two unpasteurized milk isolates from the patient's home, and fourteen product isolates (milk and cheese) collected by the Oklahoma Department of Agriculture, Food and Forestry (ODAFF) between June and November 2021. This indicates a resident pathogen contributing to product contamination.

The facility's RTE cheese products are deemed adulterated under 21 U.S.C. § 342(a)(4) due to insanitary conditions. Violations of 21 CFR Part 117 (CGMP & PC rule) include: 1. **Failure to maintain a clean and sanitary plant (21 CFR 117.35(a)):** Observed food residue on equipment, pooled water on floors, rusty/dusty exhaust fan, deteriorating equipment, hoses on floor in pooled