FDA 483 - Mead Johnson & Company, LLC - December 04, 2017

Mead Johnson Nutrition, an infant formula manufacturer in Zeeland, MI, was cited for significant issues during an FDA inspection. Observations included a failure to establish adequate process controls, leading to the presence of Cronobacter sakazakii in critical processing areas. Additionally, the firm was cited for using equipment not designed to withstand its intended environment, specifically noting a history of internal cracks in spray dryers.