Novartis Pharmaceuticals Corporation – FDA 483, Feb 6, 2026

Novartis Pharmaceuticals Corporation in Morris Plains, NJ, a biological drug product manufacturer, was cited for significant deficiencies during an FDA inspection. The firm failed to thoroughly investigate recurring foreign particulates in final product bags for CARVYKTI, lacked adequate procedures to prevent microbiological contamination for sterile products like CARVYKTI and KYMRIAH, and did not properly maintain equipment, leading to corrosion in manufacturing areas. These issues indicate a serious lack of control over manufacturing processes and environmental conditions.