FDA 483 - Candler Hospital Inc Irb - August 07, 2019

An FDA inspection of Candler Hospital Inc Irb, an Institutional Review Board, revealed two significant observations. The IRB failed to follow its written procedures for conducting continuing review of research protocols, leading to instances of unapproved or undocumented reviews. Additionally, the IRB did not promptly notify investigators in writing when research activities were disapproved or required modifications.