Novartis Pharmaceuticals Corporation – FDA 483, Dec 9, 2022

Novartis Pharmaceuticals Corporation in Morris Plains, NJ, was cited for significant deficiencies during an inspection related to the manufacturing of Kymriah product. Observations included recurring mold contamination in aseptic processing areas, continued use of primary packaging with foreign particulate matter, and unapproved manufacturing procedures. The firm also failed to adequately qualify equipment, maintain proper cleaning procedures, and conduct thorough investigations for out-of-trend results and process deviations.