FDA 483 - Douglas Terp - June 28, 2021

Douglas Terp, acting as a sponsor-investigator for Colby College, was cited for significant deficiencies in a COVID-19 screening program using an unauthorized SARS-CoV-2 Antigen Rapid Qualitative Test. Observations included using an unconfirmed diagnostic device, initiating an investigation without IRB approval, failing to obtain legally effective informed consent, and not labeling investigational devices correctly. These issues indicate a serious lack of regulatory compliance in human subject protection and device use.