FDA EIR - Laura Kooienga, M.D. - May 21, 2021

An FDA inspection of Laura A. Kooienga, M.D.'s clinical investigator site in Denver, CO, was conducted from May 17-21, 2021. This comprehensive review, under compliance program 7348.811 for Clinical Investigators, assessed compliance related to a clinical trial supporting a New Drug Application. The inspection covered various aspects, including subject records, protocol adherence, and investigational product control. While no significant FDA regulatory findings were identified leading to a Form FDA 483, the inspection noted three areas for improvement. These included the need to accurately document the exact time the site became aware of Serious Adverse Events, requiring a provider's signature for changes made by study coordinators to Adverse Event forms, and ensuring all hand-written dates were consistently legible. Additionally, an earlier serious adverse event was reported outside the protocol's 24-hour window, and waivers for two subjects' eligibility were not initially reported to the Institutional Review Board by a previous investigator, though Dr. Kooienga subsequently reported them. Dr. Kooienga acknowledged these observations and committed to implementing the necessary documentation and sign-off procedures and improving date legibility. The site demonstrated cooperation throughout the inspection.