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

TEVA Pharmaceuticals USA, Inc. in Fairfield, NJ, a finished product manufacturer, was cited for significant deficiencies during an FDA inspection. Observations included inadequate cleaning and maintenance of production equipment leading to unknown residue build-up, use of unqualified equipment for various drug products, and failure to record and justify deviations from written production procedures. These issues indicate a lack of control over manufacturing processes and potential risks to drug product quality and purity.