FDA 483 - Medstar Health Research Institute IRB - January 10, 2018

MedStar Health Research Institute, an IRB in Hyattsville, MD, was cited for four observations during an FDA inspection from January 8-10, 2018. The observations primarily concern the IRB's failure to adhere to its own written procedures for review, maintain accurate member rosters, ensure proper voting and quorum at convened meetings, and retain copies of all reviewed research proposals. These issues indicate deficiencies in the IRB's oversight and record-keeping practices.