FDA 483 - Mother Frances Hospital IRB - March 04, 2011

An FDA inspection of Mother Frances Hospital IRB in Tyler, TX, revealed significant deficiencies in its operations. The IRB failed to conduct timely continuing reviews of research studies and maintain sufficiently detailed meeting minutes. Furthermore, the IRB lacked adequate written procedures for determining review frequency, verifying material changes, and promptly reporting serious noncompliance, unanticipated problems, or suspensions to the FDA.