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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.

FDA had some audit resolution guidelines in place during our audit period; however, they did not address the submission of clearance documents to OIG. As a result, FDA did not submit any clearance documents within the required 6-month resolution period. Also, FDA did not perform periodic, formal reconciliations between OIG's stewardship reports and its own audit resolution records. Since our audit period, though, FDA has made significant progress in resolving audit recommendations.

Without resolving all audit recommendations in a timely manner, FDA runs the risk of noncompliance with Federal requirements and mismanagement of Federal funds. The prompt resolution of audit recommendations helps ensure that Federal funds are effectively and efficiently used to carry out the activities for which they were authorized.

We recommended that FDA finalize and implement formal policies and procedures for the resolution of audit recommendations, promptly resolve the 32 remaining recommendations that were past due as of September 30, 2016, and reconcile each month OIG's audit resolution information with FDA's audit resolution records and follow up on any differences noted.

FDA concurred with all of our recommendations and described corrective actions that it had taken or planned to take. FDA stated that it was updating its procedures to ensure that FDA submits OCDs along with its corrective action plans to OIG. In addition, FDA stated that it was actively working to submit OCDs and corrective action plans for all outstanding recommendations. Finally, FDA stated that it was reconciling the OIG stewardship report with FDA's audit resolution records.

Filed under: Food and Drug Administration