FDA 483 - ByHeart Inc dba Blendhouse Allerton - June 30, 2022

Dairy Farmers of America in Allerton, IA, was cited for significant sanitation and quality control deficiencies during an inspection from May to June 2022. Observations included inadequate sanitation preventive controls leading to Cronobacter contamination in infant formula production areas, a lack of auditor independence, uncalibrated measuring devices, and unsanitary building conditions with standing water. These issues indicate a serious risk to product safety and quality.