FDA 483 - UPMC Susquehanna - March 29, 2018

An FDA inspection of UPMC Susquehanna's Institutional Review Board (IRB) revealed several significant deficiencies. The firm failed to ensure proper IRB composition with unaffiliated members, did not consistently conduct timely continuing reviews of research protocols, and lacked a method for advising IRB members of expedited approvals. Additionally, the inspection found issues with maintaining written IRB procedures and including required FDA inspection statements in informed consent documents.