FDA 483 - Singing River Health System IRB - July 23, 2012

The FDA inspected Singing River Hospital System IRB in Gautier, MS, and identified significant non-compliance with regulations governing Institutional Review Boards. The IRB failed to adhere to its written procedures for reviewing research, maintain adequate documentation, and ensure proper board composition and meeting conduct. These issues indicate systemic problems in protecting the rights and welfare of human subjects in clinical investigations.