FDA EIR - Kord Strebel, MD - August 25, 2021

An FDA inspection of Dr. Kord T. Strebel, M.D., located in Las Vegas, NV, and associated with Women's Health Associates of Southern Nevada Central (WHASN)/Nevada Obstetrical Charity Clinic (NOCC), was conducted from August 10 to August 25, 2021. This IND-Initiated Clinical Investigator inspection aimed to assess compliance with Good Clinical Practice (GCP) guidelines and federal regulations for a clinical drug study. The inspection revealed several critical violations of the investigational plan and applicable regulations, resulting in the issuance of an FDA-483, Inspectional Observations. A primary concern was Dr. Strebel's significant lack of involvement and oversight in the study, with the Study Coordinator reportedly assuming full responsibility for various clinical trial activities without proper delegation or review. Specific issues included: vital signs measurements for three subjects performed outside protocol-mandated timeframes; physical examination source documents completed by an unqualified Study Coordinator without documented clinical investigator review; failure to perform required early termination procedures for four subjects (including an uncaptured endometrial biopsy for one and incomplete week 24 procedures for three others); and the absence of daily temperature logs for investigational product storage. Dr. Strebel acknowledged the observations and committed to providing a written response to address the deficiencies. He was reminded of the potential for legal sanctions if voluntary corrections are not implemented. The inspection highlighted a need for enhanced adherence to regulatory requirements and improved oversight in clinical trial conduct.