The FDA has released its second Annual Report on Food Facilities, Food Imports, and FDA Foreign Offices. Although the Report contains relatively little new information, some instructive statistics are revealed which illustrate the magnitude of the tasks facing FDA in implementing the Food Safety Modernization Act and supervision some $417 billion of domestic food products and $49 billion of food imports.

The Report states that there are 421,000 active Registered Facilities (167,000 domestic and 254,000 foreign). Of these, FDA apparently did manage to inspect some 11,000 High-Risk Facilities in FY 2011 (October 2010 to September 2011). FDA’s statistics presented in the Report do not reveal the domestic/foreign breakdown of inspections. However, it may be inferred from the inspection cost data presented that there were fewer than 1,000 foreign inspections.

FDA further states that out of 10.4 million Import-Line items in FY 2011, some 243,000 were physically examined, making the Examination Rate 2.34%. In other words, for the nearly quarter million foreign Registered Facilities the plant inspection rate has been virtually nil and the Import-Line examination rate has remained in the 2% range. Of course, the Report notes that, since implementation of PREDICT, FDA has been able to focus Import-Line examinations on higher-risk foreign Registered Facilities.

We note, as a practitioner in this system, that the Removal from Import-Alert procedure is extremely costly to violative Foreign Registered Facilities and to their US Importers due to the extended delays in the administrative Removal process. Our observation is that PREDICT does appear to be an effective tool, contributing to the effectiveness of the examination process despite the still quite low examination rate.

We post a PDF of the Report below: