FDA 483 - Indiana Orthopaedic Hospital, LLC IRB #1 - February 13, 2019

An FDA inspection of Indiana Orthopaedic Hospital, LLC IRB #1 in Indianapolis, IN, revealed significant deficiencies in its Institutional Review Board (IRB) operations. The IRB failed to properly advise members of expedited approvals, lacked a nonscientific member, did not conduct timely continuing reviews, and failed to report study suspensions to the FDA. These issues indicate a lack of adherence to regulatory requirements for IRB oversight.