FDA 483 - Aspirus Wausau Hospital IRB - December 05, 2019

An FDA inspection of Aspirus Wausau Hospital IRB in Wausau, WI, identified two observations related to the management of the Institutional Review Board. The observations primarily concerned deficiencies in maintaining an accurate IRB member roster and ensuring detailed documentation of meeting minutes, including attendance and quorum. These issues indicate a need for improved record-keeping and procedural adherence for IRB operations.