FDA 483 - KDunn and Associates, P.A. dba HealthQuilt - August 13, 2020

KDunn and Associates, P.A. dba Researchguilt in Houston, TX, was inspected from August 4-13, 2020, and received a Form 483 with seven observations. The firm failed to submit an Investigational New Drug (IND) application for a clinical study using an unapproved herbal supplement. Significant deficiencies were also noted in obtaining informed consent, including failure to obtain it from 19 subjects, lack of disclosure for alternative treatments, inadequate information on compensation for injury, and the presence of exculpatory language. Additionally, the firm lacked adequate records for the receipt and disposition of the investigational drug.