FDA 483 - Perrigo Wisconsin, LLC - April 26, 2023

An FDA inspection of Perrigo Wisconsin, LLC in Eau Claire, WI, revealed significant deficiencies in the manufacturing of infant formula, including repeated Cronobacter species contamination in finished products and the processing environment. The firm failed to establish adequate process controls, ensure sufficient qualified personnel, properly clean and sanitize equipment, and maintain complete production records. These findings indicate serious concerns regarding product safety and quality control.