FDA EIR - Recknor, Christopher M.D. - May 01, 2017

An FDA inspection of Christopher M.D. Recknor's clinical investigator site in Gainesville, GA, was conducted from April 17 to May 1, 2017. Initiated due to allegations and carried out under Good Clinical Practice (GCP) guidelines for clinical investigators, the inspection identified significant issues in the conduct of clinical trials. The regulatory framework for this inspection was Compliance Program 7348.811, Clinical Investigators and Sponsor Investigators, by the Center for Drug Evaluation and Research.

Main violations documented in a Form FDA 483 included the improper documentation of informed consent for one subject, where a family member signed on behalf of the subject without legal authorization. Additionally, the investigator failed to prepare and maintain accurate case histories, specifically lacking documentation for numerous required phone visits for multiple subjects enrolled in one study. Verbal observations also emphasized the need to ensure study medication is dispensed per protocol, thoroughly check for subjects' use of prohibited concomitant medications, and ensure only trained personnel conduct quality control reviews of investigational product accountability logs.

Dr. Recknor committed to providing a written response to the Form FDA 483 observations within 15 days. He was also reminded of his professional responsibility to ensure all studies overseen by his site comply with applicable clinical trial regulations.