FDA WARNING_LETTER - Wayne State University IRB - February 02, 2010

The FDA issued a Warning Letter to Wayne State University following an IRB inspection from January 19 to February 2, 2010, which revealed objectionable conditions and violations of 21 CFR Part 56, Part 50, and Part 812.

Key violations include: 1. **Failure to prepare and maintain adequate documentation of IRB activities [21 CFR 56.115(a)(2) and 21 CFR 56.115(a)(5)]**: * The Clinical and Translational Sciences (CTS1) - rapid review Board did not prepare minutes for 8 convened meetings between May 2008 and October 2009. The university's response, attributing this to a former employee, was deemed inadequate for not providing reoccurrence prevention. * Meeting minutes for Adult Medical (M1), Adult Medical/Pediatric IRB (MP2), and Adult Medical/Pediatric IRB (MP4) failed to document the number of IRB members voting for study approvals. * Incorrect IRB membership lists for CTS1 and M1 IRBs, misidentifying a voting member as a consultant. The university's reliance on a "programming problems" database for corrections was deemed inadequate.

2. **Failure to review proposed research at convened meetings with a majority of members present, including a nonscientific member [21 CFR 56