Wellmont Holston Valley Medical Center – FDA Warning Letter, Jul 24, 2008

This Warning Letter details objectionable conditions observed during an FDA inspection of Wellmont Holston Valley Medical Center's Institutional Review Board (IRB) from May 15 to July 24, 2008. The inspection aimed to ensure compliance with 21 CFR Part 56 (IRBs), Part 50 (Human Subjects), and Part 812 (Investigational Device Exemptions). Many violations are recurrences from a June 2006 Warning Letter.

Key violations include: 1. **Failure to maintain quorum at convened meetings (21 CFR 56.108(c))**: The IRB voted on FDA-regulated research without a majority of non-conflicted members present, a recurring issue. 2. **Failure to maintain adequate documentation of IRB activities (21 CFR 56.115(a)(2))**: Meeting minutes were inaccurate or incomplete regarding attendance, votes, and actions taken, also a recurrence. 3. **Inappropriate use of expedited review procedures (21 CFR 56.110)**: Expedited approval was granted for significant risk studies not meeting minimal risk or minor change criteria. 4. **Failure to manage conflicting interests (21 CFR 56.107(e))**: IRB members with conflicts of interest participated in voting on projects, a recurring violation. 5. **Failure to maintain adequate IRB