KDunn and Associates, P.A. dba HealthQuilt
FDA issued a warning letter to KDunn and Associates, P.A. dba HealthQuilt (Dr. Kimberly Dunn) following an August 2020 inspection of a clinical investigation studying an investigational drug for COVID-19 treatment, cure, and prevention. The firm conducted the study without submitting a required Investigational New Drug (IND) application, failed to maintain adequate drug disposition records, used informed consent forms containing prohibited exculpatory/liability-waiver language, and failed to retain required case history records including signed consent forms. FDA found the firm's corrective action responses inadequate and demanded a written response within 15 working days, warning that failure to address violations may result in regulatory action without further notice.
Flagged claims (2)
Subject agrees to waive, release, forever discharge and hold harmless the Schull Institute, KDunn and Associates, PA, HealthQuilt, Investigator, (b)(4) (maker of the supplement) its owners, principals, shareholders, investors, managers, employees, partners, attorneys, officers, directors, predecessors, successors, and assigns, from and against any and all claims, demands, causes of action or suits arising out of any type of physical, psychological or other financial injury, loss or damage, including but not limited to illness, paralysis, death, loss of earnings, economic or emotional loss, that may occur as a direct or proximate result of participation in the study.
our intent in conducting this study was to evaluate the use of (b)(4) as a dietary supplement only
Required actions (2)
Within fifteen (15) working days of your receipt of this letter, you should notify this office in writing of the actions you have taken to prevent similar violations in the future.
Failure to address the violations noted above adequately and promptly may result in regulatory action without further notice.
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