FDA fails to meet foreign inspection targets under FSMA.

  • Under the FDA Food Safety Modernization Act (FSMA), FDA was required to inspect 600 foreign food facilities in the first year post-enactment, followed by a doubling of the prior year’s inspection numbers for the each of the next five years.
  • According to a GAO report, FDA inspected only 1,323 foreign facility inspections in 2014, far short of the targeted 4,800 sites.  According to the GAO report, FDA has not met, and does not plan to meet, its FSMA targets.
  • There exists a series of disconnects between the FSMA target inspection goals, FDA’s pervasive funding struggles, the number of vacant FDA foreign office positions, and questions about whether the FSMA targets are necessary to ensure the safety of the foreign food supply.  It remains to be seen whether FDA will respond to the GAO’s urging that the Agency evaluate the sufficiency of its foreign inspection practices to protect the public health.