Crittenton Hospital Medical Center, Rochester, NY, Jan. 10

Warning Letter Bulletin, March, 2005

FDA investigator Alanna Mussawwir-Bias conducted an inspection of the IRB Sept. 28-29, 2004. The purpose of the audit was to determine if the IRB had implemented corrective actions promised in a response to a Nov. 7, 2002, warning letter and if the IRB was functioning in compliance with applicable FDA regulations.

The inspection revealed that serious violations continue, including failing to conduct an annual review of research, failure to follow procedures regarding projects that require review more than annually and failure to maintain copies of all research proposals reviewed. BiMo, QC/QS, MDR; Doc. 13381W