FDA 483 - Centra Health Inc IRB - September 14, 2009

Centra Health Inc IRB in Lynchburg, VA, was cited for numerous deficiencies in its Institutional Review Board Policy and Procedure Manual, last reviewed in January 2000. Key issues include the absence of written procedures for initial and continuing review, reporting suspensions, unanticipated problems, and noncompliance, as well as failures in maintaining detailed meeting minutes and managing conflicts of interest. The inspection revealed systemic procedural gaps impacting the oversight and approval of research studies involving human subjects.