FDA EIR - Mark Gotfried, M.D - June 01, 2021

An unannounced FDA inspection was conducted at the clinical investigation site of Mark Gotfried, M.D. in Glendale, AZ, from May 24, 2021, to June 1, 2021. The inspection aimed to assess compliance with FDA regulations concerning clinical research, specifically for a new drug used in an original marketing application, under the Bioresearch Monitoring Compliance Program (BIMO). The inspection reviewed various aspects of the clinical study, including subject records, data integrity related to sleep induction, sleep maintenance, and total sleep time for Protocol ID-078A302, which assessed the efficacy and safety of an investigational product in subjects with insomnia disorder. The review encompassed informed consent procedures, adherence to study protocols, management of investigational products, training of clinical staff, and reporting of adverse events. Significantly, no FDA Form 483, Inspectional Observations, were issued at the conclusion of the inspection. This indicates that the site demonstrated compliance with the regulatory framework governing clinical investigations. No major violations or issues were identified, and consequently, no specific corrective actions were required from this inspection.