FDA EIR - Charles E. Canter, MD - December 20, 2021

An FDA for-cause inspection of Clinical Investigator Charles E. Canter, MD, located in Saint Louis, MO, was conducted from December 14-20, 2021. The inspection, triggered by a complaint regarding a study coordinator's performance, assessed adherence to regulatory requirements under Compliance Program 7348.811 for Clinical and Sponsor-Investigators, referencing 21 CFR 312.60 and 312.62.

The inspection revealed significant deficiencies in one of the two reviewed clinical trials, leading to a 3-item Form FDA 483, Inspectional Observations. Main violations included: 1) Failure to conduct the investigation according to the investigational plan, as eligibility criteria could not be confirmed for three subjects, and investigator review of eligibility was not documented, nor were end-of-study visits verifiable. 2) Inadequate investigational drug disposition records for all three subjects, lacking details on who dispensed, quantity used, and final disposition. 3) Failure to maintain adequate and accurate case histories, with source records failing to identify who conducted various study visit procedures.

Management's response at the close-out meeting indicated steps were being taken to address these issues. Dr. Canter received a Form FDA 483 and was advised on the 15-business day timeframe for a formal response. His submitted response was later deemed adequate by the FDA on January 11, 2022, indicating resolution or a plan for resolution of the identified issues.