FDA EIR - David J. Johnson, M.D. - July 13, 2018

An FDA inspection of clinical investigator David J. Johnson, M.D., operating through Research Integrity, LLC in Owensboro, KY, was conducted from July 9-13, 2018. This initial inspection focused on Protocol 547-PPD-202, a study evaluating a treatment for severe postpartum depression, under Compliance Program 7348.811 for Clinical Investigators. The inspection uncovered several critical issues. Firstly, two of the 22 treated subjects received an overdose of the Investigational Medicinal Product (IMP) and subsequently lost consciousness. Secondly, the study site failed to adhere to the protocol's requirements for processing pharmacokinetic (PK) samples, with no documentation of proper handling. A third major issue was the failure to promptly report these unanticipated problems, specifically the subject overdoses, to the Institutional Review Board (IRB) until July 5, 2018, just days before the inspection, despite the study closing in November 2017. These observations highlight deficiencies in clinical investigation conduct. Dr. Johnson acknowledged the findings and committed to providing a written response to the FDA within 15 working days, with potential regulatory classifications and outcomes discussed.