FDA 483 - Michigan Center for Skin Care Research - May 31, 2011

An FDA inspection of Michigan Center for Skin Care Research, a bioequivalence clinical facility, identified two observations. The firm was cited for making promotional representations on its website regarding the safety and effectiveness of investigational drugs and for offering benefits to participants. Additionally, the firm failed to ensure that an Institutional Review Board (IRB) was responsible for the initial and continuing review and approval of clinical studies, specifically regarding recruitment advertisements placed online without IRB approval.