FDA 483 - Veterans Administration Long Beach Healthcare System IRB - May 17, 2019

An FDA inspection was conducted at the Veterans Administration Long Beach Healthcare System IRB from May 13 to May 17, 2019. The inspection revealed a significant observation concerning the organization's record-keeping practices. The primary issue identified was the failure to maintain copies of all research proposals reviewed and approved, as well as associated sample consent documents. Specifically, the Institutional Review Board (IRB) did not retain initial submissions from clinical investigators requesting IRB review for several projects. These missing records included initial review applications, application supplements, and informed consent forms, even though the projects were subsequently approved. This indicates a gap in the firm's adherence to regulatory requirements for comprehensive documentation of research oversight. While the FDA 483 document does not specify immediate corrective actions, it requires the Veterans Administration Long Beach Healthcare System IRB to address these observations by implementing appropriate measures to ensure all necessary research records are properly maintained to comply with applicable regulations.