FDA EIR - Robert F. Mullins, MD - April 26, 2019

An FDA inspection of Robert F. Mullins, MD, and the Joseph M. Still Research Foundation in Augusta, GA, was conducted from April 15-26, 2019. Initiated by a complaint and focusing on a clinical trial for NexoBrid®, the inspection identified significant non-compliance with regulatory standards for clinical investigators (Compliance Program 7348.811).

Main violations, detailed in an FDA-483, included a failure to conduct the investigation in accordance with the approved plan. This involved the Principal Investigator not timely reviewing and signing protocol-required documents, and patient follow-up assessments being performed at locations not listed on the FDA-1572. The firm also failed to maintain adequate and accurate case histories, with numerous protocol-required procedures and assessments omitted or improperly documented for several subjects. Additionally, the Institutional Review Board (IRB) was not promptly notified about critical changes, such as a study hold initiated by the sponsor and a subsequent shutdown of site activities for an extended period. These issues contravene 21 CFR 312.60, 312.62(b), and 312.66.

Management acknowledged the findings, attributing some to a former coordinator, and presented updated operational procedures. A formal response to the FDA-483 observations is required within 15 days.