FDA 483 - Sujith R. Kalmadi, MD - July 16, 2021

Ironwood Cancer and Research Centers in Chandler, AZ, was inspected as a clinical investigator and received two observations. The firm failed to conduct an investigational study in accordance with the signed agreement and investigational plan, specifically regarding radiological assessments for two subjects. Additionally, subject records were incomplete, as a reported adverse event of skin tears from an investigational device was not properly documented or evaluated.