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KDunn and Associates, P.A. dba HealthQuilt, operating as a clinical trial sponsor and investigator, failed to comply with federal regulations governing investigational drug studies and human subject protection during an FDA inspection of a COVID-19 treatment study conducted August 4-13, 2020. The company did not submit an Investigational New Drug (IND) application as required under 21 CFR 312.20(a) for conducting clinical investigations with an investigational new drug. The inspection, conducted under the FDA's Bioresearch Monitoring Program, identified objectionable conditions related to the sponsor's and clinical investigator's failure to adhere to statutory requirements and FDA regulations designed to protect human subjects' rights, safety, and welfare.