FDA EIR - Bernard H. Doft, M.D. - September 28, 2012

An FDA inspection of Bernard H. Doft, M.D., operating as Retina Vitreous Consultants in Pittsburgh, PA, was conducted from September 17 to September 28, 2012. This high-priority inspection, under the Bioresearch Monitoring Compliance Program (7348.811), focused on clinical investigator data for a pre-approval new drug application. The inspection uncovered multiple regulatory violations cited under 21 CFR 312.60, 312.62(b), and Part 50. Key issues included the failure to conduct the investigation according to the approved plan, with two subjects enrolled despite not meeting eligibility criteria, and visual acuity assessments performed by uncertified personnel. Furthermore, visual acuity examiners inappropriately conducted pre-treatment intraocular pressure measurements in 34 instances, violating protocol. Inadequate and inaccurate case histories were identified, including 10 instances of incorrect or falsified examiner signatures on visual acuity worksheets. Critically, informed consent was not obtained from two subjects prior to performing study procedures, and for two subjects unable to read the consent, the required oral short form was not properly used or witnessed. Dr. Doft committed to correcting the deficiencies and providing a written response to the FDA 483 observations, acknowledging his responsibility as Principal Investigator for study oversight, personnel training, and protocol adherence. Management also agreed to update their standard operating procedures to precisely document when informed consent is obtained.