FDA 483 - PBM Nutritionals, LLC - June 12, 2025

PBM Nutritionals, LLC in Covington, OH, was cited for significant deficiencies in its environmental monitoring program during an inspection of its infant formula manufacturing. The firm failed to establish adequate process controls to prevent infant formula from becoming adulterated due to microorganisms, specifically Cronobacter sakazakii. This observation regarding process controls was a repeat finding from a previous inspection.