Perrigo Wisconsin, LLC – FDA 483, Feb 13, 2026

Perrigo Wisconsin, LLC, an infant formula manufacturer in Eau Claire, WI, received four observations during an FDA inspection, many of which were repeat findings. The inspection revealed significant deficiencies in equipment maintenance leading to foreign particle contamination, inadequate process controls resulting in Cronobacter sakazakii contamination from rain leaks, and improper cold storage temperatures without supporting microbiological studies. Additionally, the firm was cited for deficient personnel practices and sanitation controls, indicating a pattern of persistent issues impacting product quality and safety.