FDA EIR - Koriand'r Williams, M.D. - December 22, 2022

An FDA inspection of Koriand’R Williams, M.D., operating as Elixir Research Group in Houston, TX, was conducted from December 13 to December 22, 2021. This was a high-priority "For Cause" assignment under the Bioresearch Monitoring Compliance Program, investigating two clinical studies involving investigational products. The regulatory framework for the inspection included 21 CFR Parts 50, 56, 58, 11, and 312.

The inspection revealed two primary objectionable conditions, resulting in the issuance of an FDA Form 483. First, the clinical investigator failed to adequately supervise the investigations, signing off on incomplete staff paperwork that conflicted with supporting documentation such as laboratory results and EKGs. This led to inconsistencies in subject eligibility records. Second, there was a failure to prepare and maintain accurate case histories, with inadequate documentation of critical observations and data. This included instances of under-reporting of adverse events and study deviations, and a lack of proper clinical investigator progress notes for abnormal findings, even those deemed not reportable by protocol (e.g., subjects with abnormal ECGs or elevated liver enzymes lacking appropriate follow-up documentation).

The firm chose to respond to the FDA 483 in writing, indicating an obligation to address these findings and implement corrective actions to ensure compliance with regulatory requirements for clinical investigations.