FDA WARNING_LETTER - North Memorial Medical Center - March 30, 2010

The FDA issued a Warning Letter to North Memorial Medical Center following an inspection of its Institutional Review Board (IRB) from March 23-30, 2010. The inspection aimed to ensure compliance with 21 C.F.R. Parts 56, 50, and 812, and to protect human subjects in investigational device studies.

The inspection revealed several violations: 1. **Inadequate Written Procedures (21 CFR 56.108(a) and (b)):** The IRB lacked a procedure for promptly reporting serious or continuing noncompliance and serious/unexpected adverse events to institutional officials and the FDA. Specific instances of delayed reporting for the "Genentech AVF 4096g" study were cited, with events from 2008 and 2009 not reported until 2009 or 2010. 2. **Failure to Meet Quorum Requirements (21 CFR 56.108(c)):** The IRB reviewed and approved FDA-regulated research without a majority of members present, including the required nonscientific member. Examples from 2007, 2008, and 2009 meetings showed fewer than half of the rostered members present for approvals. 3. **Inadequate Documentation of IRB Activities (21 CFR 56.115(