Christus Spohn Hospital Corpus Christi - Memorial Campus – FDA Warning Letter, Feb 4, 2011

This FDA Warning Letter, dated May 5, 2011, addresses Christus Spohn Hospital Corpus Christi – Memorial Campus regarding objectionable conditions observed during an FDA inspection of their Institutional Review Board (IRB) from January 28 to February 4, 2011. The inspection aimed to ensure compliance with 21 CFR Part 56 (IRBs), Part 50 (Protection of Human Subjects), and Part 812 (Investigational Device Exemptions) for device investigations.

The letter identifies three violations: 1. **Failure to review proposed research at convened meetings with a majority of members present, including a nonscientific member (21 CFR 56.108(c)).** For example, on June 24, 2009, and August 26, 2009, the IRB lacked a majority quorum. The hospital's response regarding new policies and education was deemed inadequate due to insufficient detail on the new policy and staff training documentation. 2. **Failure to prepare and maintain adequate documentation of IRB activities, specifically meeting minutes showing vote details (21 CFR 56.115(a)(2)).** Minutes from February 2009 to July 2010 lacked vote counts. The hospital's response, detailing template revisions and audits, was inadequate as it provided only an excerpt and lacked staff training documentation. 3.