Steven W. Boyce, M. D. – FDA EIR, Sep 15, 2011

An FDA inspection was conducted at Steven W. Boyce, M.D., from August 24 to September 15, 2011, focusing on clinical investigator responsibilities for an investigational drug study. The inspection revealed significant deviations from regulatory requirements under 21 CFR Parts 50 and 312, concerning human subject protection and investigational new drug regulations. Key violations included the failure to obtain timely Institutional Review Board (IRB) continuing review approval, leading to the enrollment of five subjects after study approval had expired. Furthermore, informed consent forms for these subjects bore an unofficial IRB stamp, lacked required witness signatures, or were missing critical pages or dates. The study also failed to adhere to the investigational plan, with instances of incomplete protocol-required electrocardiograms and overdue postoperative assessments. A research pharmacy assistant handled investigational products without documented authorization. Additionally, one serious adverse event (elevated creatinine) was not reported to the sponsor as required. The informed consent document also omitted a statement about the possibility of FDA record inspection. Upon conclusion, an FDA 483 was issued, detailing these observations. Dr. Boyce acknowledged the findings and committed to providing a written response to the agency regarding the corrective actions. The FDA informed him of potential regulatory actions, including re-inspection, warning letters, or disqualification.