FDA WARNING_LETTER - Melanie M. Hoppers, M.D./Physicians Quality Care - December 15, 2022

The FDA issued a Warning Letter to Dr. Hoppers following a December 6-15, 2022, inspection of a clinical site, identifying objectionable conditions in the conduct of clinical investigations under the Bioresearch Monitoring Program. The primary violation cited was the failure to ensure the investigation was conducted according to the investigational plan, specifically regarding subject eligibility for Protocol (b)(4). The protocol required subjects to have a laboratory-confirmed (b)(4) test result at randomization. Six subjects were randomized and dispensed investigational drug without meeting this criterion, with some having negative or (b)(4) test results.

Dr. Hoppers acknowledged responsibility and attributed the issues to a clinical research coordinator, stating self-reporting to the IRB, state nursing board, and sponsor. Corrective actions included hiring a clinical research director to develop a quality management system, updating SOPs (e.g., Responsibilities of the Principal Investigator, Diagnostic and Lab Report Review Process), and staff training. However, the FDA deemed the response inadequate, lacking sufficient detail on how Dr. Hoppers will ensure adequate supervision and oversight of delegated tasks, prevent future violations, and how new SOPs will ensure compliance. The FDA also noted that the updated SOPs did not explicitly identify the principal investigator as responsible for subject eligibility determinations, source documentation, or regulatory file management. The letter requires a written response within 15 business days detailing corrective actions, including documentation of additional SOPs and training, and an