Teva API, Inc. – FDA 483, Jul 18, 2017

Teva Pharmaceuticals USA, inc, a commercial sponsor in Parsippany, NJ, was cited for failing to ensure proper monitoring of an investigational study. This led to the use of unapproved photocopies of the WOMAC Score Sheet, resulting in distorted data and incorrect subject assessments. The firm's interim monitoring visit reports did not identify these deviations, nor did they document verification of corrective actions.