FDA 483 - Franciscan Health IRB - February 13, 2019

The FDA inspected Franciscan Health IRB in Indianapolis, IN, and issued a Form 483 with two observations. The inspection revealed deficiencies in maintaining detailed IRB meeting minutes, specifically regarding attendance and vote counts for actions on FDA-regulated research. Additionally, the firm failed to maintain accurate and complete lists of IRB members, lacking earned degrees and failing to update member status promptly.