This post was written by Paul Sheives. The Government Accountability Office (GAO) has issued two reports addressing foreign FDA inspectional issues.

  • In the first report entitled “Overseas Offices Have Taken Steps to Help Ensure Import Safety, but More Long-Term Planning Is Needed,” GAO sought to examine (1) the steps FDA’s overseas offices have taken to help ensure the safety of imported products; and (2) the extent to which FDA has engaged in long-term strategic and workforce planning for its overseas offices. GAO recommended that FDA take steps to enhance strategic planning to ensure coordination between overseas and domestic activities and develop a workforce plan to help recruit and retain overseas staff.
  • The second report, entitled “FDA Has Conducted More Foreign Inspections and Begun to Improve Its Information on Foreign Establishments, but More Progress Is Needed,” is a follow-up report monitoring FDA’s progress towards addressing the recommendations of a 2008 GAO report concluding that FDA should increase foreign drug inspections and improve the information it receives to better manage such inspections. GAO found that FDA has not yet fully addressed these weaknesses at a time when the volume of imported drugs and the number of foreign establishments producing these drugs have been increasing.

FDA agreed with the recommendations from both reports.