The Food and Drug Administration Did Not Submit Clearance Documents for Any Audit Recommendations During Fiscal Years 2015 and 2016 but Has Since Made Significant Progress

The U.S. Department of Health and Human Services (HHS), Food and Drug Administration (FDA), did not submit an Office of Inspector General (OIG) clearance document for any of the 166 audit recommendations, which were identified in OIG stewardship reports, during Federal fiscal years (FYs) 2015 and 2016. As a result, all of the recommendations were outstanding, and listed on the stewardship report as past due for resolution, as of September 30, 2016. However, for 134 of the 166 recommendations (from 7 information technology audit reports), FDA did address the audit recommendations in detail, to include statements of corrective actions, in its comments on those reports. These 166 past-due recommendations were procedural in nature; none of them involved dollar amounts such as recommended disallowances.