FDA EIR - ByHeart Inc dba Blendhouse Allerton - April 03, 2019

A limited scope surveillance inspection of DairiConcepts LP, an infant formula premix and powdered milk protein ingredients manufacturer in Allerton, IA, was conducted by the FDA from April 2 to April 3, 2019. The inspection focused on Current Good Manufacturing Practices (cGMPs) under 21 CFR 117 and the Infant Formula Program (7321.006). Key findings included the presence of foreign material (metal) in infant formula premix, traced to a rotary valve issue, resulting in product rejection. Environmental monitoring revealed a positive swab for Cronobacteria, which was addressed with sanitation and retesting, but the underlying root cause remained unidentified. Additionally, production records were found to be illegible due to scratched-out information. While no formal FDA Form 483 (Inspectional Observations) was issued, these concerns were thoroughly discussed with plant management, including the need to determine the Cronobacteria root cause and improve record-keeping practices. Management committed to addressing these issues. The firm was also reminded of its ongoing responsibility to comply with the Food, Drug, and Cosmetic Act. Initial reluctance to provide manufacturing records was resolved after discussion.