FDA 483 - TEVA Pharmaceuticals USA, Inc. - November 10, 2022

TEVA Pharmaceuticals USA, Inc. in Fairfield, NJ, a finished product manufacturer, was cited for three observations during an FDA inspection. The firm failed to properly clean and maintain equipment, used equipment not appropriately designed or qualified for its intended use, and did not record or justify deviations from production and process control procedures. These issues led to concerns regarding product contamination and defective coating for drug products.