FDA 483 - Perrigo Wisconsin, LLC - November 29, 2023

An FDA inspection of Perrigo Wisconsin, LLC, an infant formula manufacturer in Eau Claire, WI, revealed significant deficiencies in process controls, sanitation, and personnel qualifications. The firm repeatedly failed to prevent environmental contamination, particularly with Cronobacter species, and exhibited poor cleaning practices and inadequate employee training. These issues, some of which are repeat observations, indicate a high risk of product adulteration.