FDA 483 - Franciscan Health IRB - February 13, 2019

An FDA inspection conducted on February 12-13, 2019, at Franciscan Health IRB, an Institutional Review Board in Indianapolis, Indiana, identified significant issues in their operational procedures. The inspection resulted in a Form FDA 483, outlining observations made under the Federal Food, Drug and Cosmetic Act, which mandates compliance for such establishments. The primary concerns involved the accuracy and completeness of essential records for both their Eastern and Central boards. Firstly, meeting minutes lacked sufficient detail regarding attendance and voting, particularly for FDA-regulated research, with discrepancies noted between reported attendee numbers and actual vote counts. There were also questions about member presence during critical voting periods. Secondly, the firm failed to maintain an accurate and updated roster of IRB members. This included not identifying members by their earned degrees and failing to promptly remove members who had resigned or taken a leave of absence. In one instance, a member participated in voting on research without being officially listed on the IRB's membership roster. These observations indicate a need for Franciscan Health IRB to implement robust corrective actions to ensure meticulous record-keeping for IRB meetings and maintain precise, current member lists to comply with regulatory expectations.