EXECUTIVE SUMMARY:

Our objectives were to determine whether the Food and Drug Administration (FDA) had (1) resolved all audit recommendations as of December 31, 2005, and (2) resolved audit recommendations in a timely manner during calendar years (CY) 2003–2005. 

As of December 31, 2005, FDA had not resolved eight audit recommendations, all of which were past due for resolution. Additionally, during CYs 2003–2005, FDA resolved 306 of the 314 audit recommendations, but it did not resolve 287 of these recommendations within the required 6-month period. 

We recommended that FDA (1) resolve the outstanding audit recommendations and (2) resolve all audit recommendations within 6 months of receiving the audit reports as required. FDA concurred with all findings.