FDA 483 - Frank C. Sciurba, M.D. - February 22, 2022

An FDA inspection of Frank C. Sciurba, M.D. in Pittsburgh, PA, a clinical investigator, revealed significant deficiencies in the conduct of an investigational study. The firm was cited for enrolling subjects who did not meet protocol criteria and using an expired investigational device. Additionally, subject case history records were found to be inaccurate and incomplete, and records for returned investigational devices lacked essential details.