Contaminated Containers, Mold Steer FDA to Untitled Letter for Novartis’ Kymriah

Drug containers contaminated with wood, cellulose, brass and steel as well as multiple corrective and preventive actions (CAPA) to address mold are among the reasons the FDA listed in its untitled letter to Novartis Pharmaceuticals over its biological product Kymriah (tisagenlecleucel).
Source: Drug Industry Daily