FDA 483 - John Muir Medical Center IRB #1 - October 15, 2021

An FDA inspection of John Muir Medical Center IRB #1 in Concord, CA, revealed two significant observations. The inspection found deficiencies in the preparation and maintenance of IRB meeting minutes, specifically regarding the documentation of actions taken and vote counts. Additionally, the IRB was cited for not including at least one member who is not otherwise affiliated with the institution, as required.