FDA 483 - Suken A. Shah, MD - June 01, 2023

Suken A. Shah, MD, a Sponsor-Investigator in Wilmington, DE, was cited for significant deficiencies during an FDA inspection of an investigational study. Observations included a lack of proper monitoring documentation and inadequate staff training. The firm also failed to adhere to the investigational plan regarding adverse event reporting and submission of Data Safety Monitoring Board reports to the IRB.