FDA 483 - William Wierda,, M.D. - December 21, 2015

An FDA inspection of William G. Wierda, M.D., a clinical investigator in Houston, TX, identified critical failures in the timely reporting of serious adverse events to the study sponsor. The firm did not adhere to protocol requirements for notifying the sponsor about significant incidents, including a subject's death, a cardiac procedure, and a hip fracture. These lapses indicate a serious deficiency in clinical trial oversight and subject safety reporting.