FDA 483 - WCG IRB, Inc - August 24, 2018

An FDA inspection of Western Institutional Review Board Inc in Puyallup, WA, revealed a significant issue with informed consent documents. The IRB approved forms for an investigational device study inaccurately stated that the device's safety had been tested and proven, failing to adequately describe experimental procedures. This indicates a serious concern regarding the protection of human subjects in clinical trials.