FDA EIR - Koren, Michael J., MD - February 02, 2015

An FDA inspection of Michael J. Koren, M.D., Chief Executive Officer of Jacksonville Center for Clinical Research, was conducted from January 28 to February 2, 2015, under Compliance Program 7348.811 for Clinical Investigators. The high-priority inspection focused on Dr. Koren's conduct of a specific clinical study. The inspection revealed several issues, leading to the issuance of an FDA-483, Inspectional Observations. The primary violations included a failure to adhere to the investigational plan (21 CFR 312.60) and inadequate recordkeeping (21 CFR 312.62(b)). Specifically, one subject who met exclusionary criteria due to an abnormal laboratory value was enrolled after the test was impermissibly repeated. Additionally, a subject's case history contained discrepant documentation regarding the use of a prohibited medication, with screening records conflicting with a physical examination report. A verbal observation also noted a subject taking another prohibited medication prematurely. Dr. Koren disagreed with the observations, indicating he would submit a written response. He contended that repeating the laboratory test was a responsible clinical judgment and argued that some documentation issues were due to sub-investigator error or concerned non-required reports. The FDA emphasized that all pertinent documents are considered source records and must be accurate. Dr. Koren also asserted clinical judgment should take precedence over regulatory interpretation in certain instances.