FDA 483 - Pomona Valley Hospital Medical Center IRB #1 - June 28, 2023

An FDA inspection of Pomona Valley Hospital Medical Center's Institutional Review Board (IRB) identified two significant observations. The IRB failed to ensure a quorum was met for convened meetings when reviewing proposed research and full board renewals. Additionally, the required list of IRB members was not adequately maintained, lacking crucial details such as earned degrees and representative capacities for multiple years.