FDA WARNING_LETTER - KDunn and Associates, P.A. dba HealthQuilt - August 13, 2020

This Warning Letter addresses objectionable conditions observed during an FDA inspection of KDunn and Associates, P.A. dba HealthQuilt (sponsor) and Dr. Dunn (clinical investigator) from August 4-13, 2020. The inspection reviewed a clinical investigation of the investigational drug (b)(4) for COVID-19. The FDA concluded that HealthQuilt and Dr. Dunn failed to adhere to statutory requirements and FDA regulations governing clinical investigations and human subject protection. Key violations include the failure to submit an Investigational New Drug (IND) application for (b)(4), which was determined to be an unapproved new drug and not a dietary supplement, as required by 21 CFR 312.20(a), 312.20(b), and 312.40(a). Additionally, the firm failed to maintain adequate records showing the receipt, shipment, or disposition of the investigational drug (21 CFR 312.57(a)). The clinical investigator failed to obtain informed consent in accordance with 21 CFR part 50, specifically by including exculpatory language in consent forms (21 CFR 312.60 and 21 CFR 50.20). Lastly, the firm failed to retain required study records, including at least eight informed consent forms, for the specified retention period (21 CFR 312.62(c)). HealthQuilt's August 27, 2020, response to the Form FDA 483 was deemed inadequate due to insufficient detail in corrective action plans and a misunderstanding of regulatory applicability. The FDA requires a written response within fifteen working days detailing actions taken to prevent future violations, emphasizing that failure to adequately address these issues may result in further regulatory action.