FDA EIR - Pinsky Mark, MD - September 28, 2012

An FDA inspection of clinical investigator Pinsky Mark, MD, in Palm Beach Gardens, FL, was conducted from September 17 to September 28, 2012. The audit focused on a clinical trial supporting a premarket approval (PMA) application, with initial concerns regarding the trial's conduct without an approved Investigational Device Exemption (IDE). The inspection identified significant deviations from regulatory requirements and the study protocol. Main violations included conducting an unapproved 12-month follow-up visit for subjects without Institutional Review Board (IRB) notification or approval, and failure to ensure subjects received their correctly allocated investigational devices. Further issues involved informed consent procedures: forms lacked comprehensive risk descriptions, non-IRB approved versions were used, copies were not provided to subjects, and original signed forms were reportedly discarded. Device accountability records were incomplete, lacking proper documentation for disposal or return of used and unused devices. Additionally, source documents for device administration and assessments were not consistently signed and dated by the performing personnel. These findings were documented on a Form FDA 483. Dr. Pinsky expressed intent to provide a written response to address these observations, highlighting the need for adherence to FDA regulations (e.g., 21 CFR Part 50 and Part 812) governing clinical investigations and protection of human subjects. Recommendations included ensuring all necessary regulatory approvals are in place and providing staff with Good Clinical Practice training.