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

TEVA Pharmaceuticals USA, Inc. in Fairfield, NJ, was inspected from November 1-10, 2022, and received three observations related to significant GMP deficiencies. The observations highlight issues with equipment cleaning and maintenance, inadequate equipment design and qualification for intended use, and failures to record and justify deviations from production procedures, particularly concerning product quality complaints. These findings indicate a moderate level of non-compliance with manufacturing controls and quality assurance.