OIG Report Suggests Improvements to FSMA Enforcement

A report from the Office of the Inspector General (OIG) of the U.S. Department of Health and Human Services has concluded that the Food and Drug Administration (FDA) fails to adequately conduct or follow up on food-safety inspections required by the 2011 Food Safety Modernization Act (FSMA). OIG reportedly found that while FDA is “on track” to meet inspection timeframes for the initial mandate, future inspection timeframes are two years shorter and FDA may not be able to meet them. The report also stated that FDA did not always take action when it found significant safety violations and that the agency “commonly relied on facilities to voluntarily correct the violations” instead of taking advantage of FSMA administrative tools. FDA “consistently failed to conduct timely followup inspections” to ensure facilities made the necessary corrections, the report noted. In addition, “inaccuracies” in domestic facility data caused FDA to attempt inspections at the facilities of closed companies. According to the OIG report, FDA concurred with the recommendations to improve inspections and follow-up procedures.