483
Indiana Orthopaedic Hospital, LLC IRB #1Indiana Orthopaedic Hospital, LLC IRB #1 – FDA 483, Feb 13, 2019
Record Details
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.
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