FDA 483 - Shailender Bhatia - November 30, 2016

Dr. Shailender Bhatia, a clinical investigator in Seattle, WA, was inspected by the FDA from November 16-30, 2016. The inspection revealed that the clinical investigation was not conducted in accordance with the signed statement of investigator and investigational plan. This included failures to report serious adverse events to the sponsor within the specified timeframe and to perform required post-infusion ECG assessments for multiple subjects.