FDA EIR - Jenis, Louis G., M.D. - December 07, 2011

An FDA inspection of Louis G. Jenis, M.D., operating as The Boston Spine Group in Newton, MA, was conducted from November 15 to December 7, 2011. This inspection, carried out under the Bioresearch Monitoring Compliance Program 7348.811, focused on an investigational device study. The primary violations, documented in a two-item Form FDA 483, concerned failures to adhere to regulatory requirements for investigational device studies.

Main issues included: 1) Inadequate protection of subject rights, safety, and welfare. This involved a patient undergoing surgery at the incorrect spinal level, which required a second corrective procedure, and two sub-investigators performing surgical interventions on study subjects without receiving the necessary operative technique training. 2) The investigation was not conducted according to the signed agreement and investigational plan. Specific problems included numerous inconsistencies, inaccuracies, and failures in adverse event and serious adverse event reporting, often with untimely submissions. Additionally, patient randomization occurred outside the protocol's stipulated timeframe, and the Clinical Investigator twice failed to submit continuing review reports to the Institutional Review Board (IRB) before their expiration dates, causing lapses in study approval. Dr. Jenis acknowledged these observations and stated he would provide a written response to the FDA.