FDA 483 - Centracare St. Cloud Hospital - Irb - February 18, 2022

An FDA inspection of Centracare St. Cloud Hospital - Irb, an Institutional Review Board, revealed significant deficiencies in its written procedures. The IRB failed to establish and maintain adequate documentation for various critical processes, including reporting unanticipated problems, noncompliance, and determining review frequency or device risk. These issues indicate a lack of robust procedural controls for human subject protection.