FDA 483 - Ram K. Shrivastava, M.D. - July 26, 2019

Eastside Comprehensive Medical Center, Llc, a clinical investigator in New York, was cited by the FDA for deficiencies during an inspection. The firm failed to promptly report unanticipated problems involving risk to human subjects to the IRB and did not maintain adequate case histories for clinical investigations. These observations highlight issues with oversight and documentation in human subject research.