FDA EIR - Frank Balis, M.D. - July 07, 2014

An FDA inspection of Frank Balis, M.D., located in Philadelphia, PA, was conducted from June 12, 2014, to July 7, 2014. The inspection, performed under Compliance Program 7348.811 for Clinical Investigators, focused on Phase III neuroblastoma protocols DIV-NB-301 and DIV-NB-302. Significant violations were identified, leading to the issuance of an FDA Form 483, Inspectional Observations. Main issues included a failure to follow the investigational plan, specifically regarding the prompt reporting of serious adverse events to the sponsor, with considerable delays noted for multiple subjects. Additionally, one subject was enrolled into the trial outside the protocol's specified timeframe. A failure to properly document informed consent was also cited, as an enrolled subject was not reconsented following a protocol amendment that included an updated consent form detailing changes in investigational drug administration. Management was also verbally alerted to other issues, such as insufficient documentation of roles and responsibilities and missing physician signatures on a consent form. Dr. Balis committed to providing a written response within 15 business days and indicated intentions to implement corrective and preventative actions to ensure future compliance with regulatory requirements (21 CFR 312.60 and 21 CFR 50.27(a)).