FDA WARNING_LETTER - Hamilton Medical Center - May 28, 2008

This FDA Warning Letter, dated September 2, 2008, informed Hamilton Medical Center CEO John S. Bowling of objectionable conditions observed during an FDA inspection of their Institutional Review Board (IRB) from May 20-28, 2008. The inspection assessed compliance with 21 C.F.R. Parts 56, 50, and 812 concerning investigational device exemptions and human subject protection. The FDA identified serious violations, acknowledging the IRB Facilitator's June 3, 2008 response to the FDA 483. Key deficiencies included: 1) Failure to have adequate written procedures governing IRB functions, such as continuing review, determining review frequency, ensuring changes are IRB-approved, and prompt reporting of unanticipated problems (21 CFR 56.108(a) and (b)). 2) Failure to ensure IRB reviews occurred at convened meetings with a majority of members, including a nonscientific member (21 CFR 56.108(c)). 3) Failure to conduct continuing review of research at least annually (21 CFR 56.109(f)). 4) Failure to prepare and maintain adequate documentation of IRB activities, including detailed meeting minutes and complete member lists (21 CFR 56.115(a)(2) and (a)(5)). The initial response was deemed inadequate due to a lack of documented new policies, staff training, and implementation timelines. Hamilton Medical Center must provide written documentation of corrective actions, including revised procedures, training, and timelines, within fifteen working days to prevent further regulatory action.