FDA 483 - Stephen S. Kasparian, MD - September 02, 2021

An FDA inspection of Stephen S. Kasparian, MD in Fall River, MA, from August 30 to September 2, 2021, revealed significant issues with data integrity in clinical investigations. The firm failed to accurately record primary efficacy data for multiple subjects and did not accurately document an adverse event. These findings indicate a lack of adherence to the signed Statement of Investigator and proper record-keeping practices.