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

The FDA inspected Perrigo's Gateway infant formula manufacturing facility from March 6 to April 26, 2023, identifying significant violations of 21 C.F.R. Part 106 (Infant Formula Rule) and the Federal Food, Drug, and Cosmetic Act. Key deficiencies included a failure to establish adequate process controls to prevent microbial adulteration (21 C.F.R. § 106.55(a)). The inspection revealed repeated Cronobacter spp. positives in finished products across multiple campaigns and persistent Cronobacter sakazakii in environmental samples, indicating resident pathogens and inadequate sanitation procedures. Root cause investigations were found lacking, specifically in the absence of Whole Genome Sequencing (WGS) for isolates and immediate sanitation without pre-clean swabbing. The firm's environmental monitoring program was deemed insufficient, failing to detect pathogens for months and over-relying on Enterobacteriaceae monitoring. Additionally, Perrigo failed to promptly notify FDA of adulterated infant formula (Gerber Good Start Soothe Pro) released into interstate commerce, violating 21 C.F.R. § 106.150. While Perrigo submitted a corrective action plan, FDA requires further actions, including a thorough evaluation of sanitation in product disposition and comprehensive root cause analyses for persistent pathogens. The company must respond within 15 working days, detailing corrective steps to avoid potential legal action.