FDA 483 - Perrigo Wisconsin, LLC - April 14, 2022

Gerber Products Company dba Nestle Nutrition in Eau Claire, WI, was inspected and received a Form 483 with three observations. The inspection revealed significant issues with process controls leading to Cronobacter sakazakii contamination in the infant formula production environment and product, as well as deficiencies in personnel hygiene practices and cleaning/sanitizing record-keeping and procedures. These findings indicate serious concerns regarding the facility's ability to prevent adulteration of infant formula.