FDA 483 - Naval Medical Center Portsmouth - March 27, 2019

An FDA inspection conducted at Naval Medical Center Portsmouth from March 25-27, 2019, identified significant deficiencies in the documentation practices of its Institutional Review Boards (IRB). The primary observation highlighted that minutes of IRB meetings were not maintained with sufficient detail to accurately reflect attendance and voting actions, including the precise number of members voting for, against, or abstaining on decisions. Specifically, the inspection report detailed multiple instances of inconsistencies. For example, meeting minutes from April 26, 2017, showed an individual marked as present on the attendance sheet, but not in the corresponding minutes or signature page. Further issues included unexplained fluctuations in the recorded number of voting members during meetings held on March 22, 2017, and June 28, 2017. These discrepancies involved members reportedly entering or leaving meetings, leading to changes in voting totals that were not adequately accounted for in the official records. These observations indicate a need for Naval Medical Center Portsmouth to review and enhance its record-keeping procedures for IRB meetings. As a recipient of an FDA Form 483, the firm is expected to conduct a thorough investigation into these findings and implement appropriate corrective and preventive actions to ensure accurate and complete documentation of all IRB activities, thereby affirming compliance with federal regulations governing human subject protection.