WASHINGTON — The U.S. Food and Drug Administration inspects less than a quarter of food facilities each year, and 56% of food facilities have gone five or more years without inspection, according to a recent report from the Department of Health and Human Services’ inspector general.
Between fiscal years 2004 and 2008, the F.D.A. inspected annually an average of 24% of the food facilities subject to inspection, and there are no specific guidelines that dictate the frequency inspections should occur. Additionally, the number of food facilities the F.D.A. inspected declined between 2004 and 2008 even though the overall number of food facilities increased. The number of facilities that have been given a “high risk” designation has declined. F.D.A. officials have said the overall decline in F.D.A. inspections has mainly been the result of a decline in staffing levels.
The number of inspections classified as “official action indicated” has declined over time from 614 in 2004 to 283 in 2008. The F.D.A. took regulatory action against 46% of the facilities with these classifications, but for the remaining facilities, the F.D.A. lowered the classification or took no regulatory action.
For the 36% of facilities with O.A.I. classifications in 2007, the F.D.A. took no additional steps to ensure violations were corrected.
The inspector general is recommending increasing the frequency of food facility inspections with particular emphasis on high-risk facilities, providing additional guidance about when it is appropriate to lower O.A.I. classifications, taking appropriate actions against facilities with O.A.I. classifications, and ensuring violations are corrected for all facilities with O.A.I. classifications. Additional recommendations include considering seeking authority to impose civil penalties through administrative proceedings against facilities that don’t voluntarily comply with regulations and seeking authority to allow F.D.A. to access facilities’ records during the inspection process.