FDA 483 - Teva Branded Pharmaceutical Products R&D - June 30, 2016

Teva Pharmaceuticals, a pharmaceutical corporate headquarters in Horsham, PA, was inspected regarding its pharmacovigilance practices. The inspection revealed significant deficiencies in adverse drug experience reporting procedures, including late submissions of serious and unexpected adverse events, unapproved written procedures, and unvalidated software used for adverse event management. These issues indicate a systemic failure in their post-marketing surveillance and quality control processes.