FDA 483 - Perrigo Wisconsin, LLC - July 25, 2016

An FDA inspection of Gerber Products Corp (dba: Nestle Nutrition-Gateway) in Eau Claire, WI, from July 25-28, 2016, revealed three observations. The firm was cited for deficiencies in quality control, including missing verification initials for probiotic ingredients, inadequate backflow prevention in a COP tank, and incomplete cleaning and sanitation records. These issues highlight a need for improved adherence to manufacturing and record-keeping standards.