FDA 483 - Dawes Fretzin Clinical Research Group, Llc. - May 01, 2025

During an inspection conducted from April 28 to May 1, 2025, the U.S. Food and Drug Administration (FDA) issued a Form 483 to Scott A. Fretzin, M.D. Dawes Fretzin Clinical Research Group, Llc. The inspection identified significant deviations from good clinical practices and the investigational plan during a bioequivalence/bioavailability clinical study.

Key observations included the enrollment of subjects who did not meet protocol-required eligibility criteria. Specifically, one subject was admitted while actively using a prohibited topical atopic dermatitis treatment, and another lacked documented adherence to the required dual contraception method. Furthermore, the firm failed to conduct the study in accordance with its own investigational plan, as evidenced by the absence of critical primary source documents. These documents should have confirmed discussions with subjects regarding the necessary washout periods for prohibited medications before study participation, a requirement that was not adequately recorded for several individuals.

This FDA 483 serves as a report of observations indicating practices that are not in compliance with federal regulations governing clinical trials. While not a final determination of compliance, the firm is expected to thoroughly review these findings and implement comprehensive corrective actions to address each observation and ensure future adherence to regulatory standards and study protocols.