FDA Slammed Over Lax Enforcement

Despite tougher enforcement tools granted by the Food Safety Modernization Act (FSMA), FDA took no advisory or enforcement actions in response to 22 percent of the significant inspection violations it uncovered from 2011-2015, according to an audit by the Office of Inspector General (OIG) at the Department of Health and Human Services, FDA’s parent agency.

And when the FDA did take enforcement action, it was often slow in coming. Of particular concern, FDA most commonly asked facility owners to voluntarily correct serious violations, which didn’t always happen, instead of taking advantage of new powers granted by FSMA, including suspending a food facility’s registration, issuing a mandatory recall, or administratively detaining certain foods.

In one example, OIG said FDA inspectors found Listeria monocytogenes in a facility that also had rainwater visibly leaking through the roof directly above the food preparation area. The facility also had cracks and holes in walls and floors that prohibited adequate cleaning. Soon after the inspection, FDA issued a warning letter requesting prompt corrective actions. But the violations went uncorrected for two years, despite three additional inspections that documented ongoing unsanitary conditions and the continued presence of Listeria.

“This facility was not unique,” the report says. “If FDA does not take swift and effective action to ensure that all violations are corrected, it is unable to guarantee that the food handled by these facilities is safe and free from disease-causing organisms, chemicals, or other harmful substances.”

The September 2017 OIG report, “Challenges Remain in FDA’s Inspections of Domestic Food Facilities,” focuses on inspections conducted during FSMA’s first five years (2011-2015). FSMA requires FDA to inspect high-risk facilities at least once during an initial five-year inspection cycle and then at least once every three years afterward. Non-high-risk facilities must be inspected at least once during the initial seven-year cycle and then at least once every five years afterwards. Prior to FSMA there were no such set timeframes.

FDA reported inspecting all but nine of the 21,086 high-risk U.S. facilities as required by the end of 2015, and had also inspected about two-thirds of the 61,010 non-high-risk facilities by that time. With two years to go for the latter, the agency was on track to finish the rest of the non-high-risk facilities by the end of 2017.

OIG agreed to this assessment, but also noted that FDA counted a facility it attempted to inspect—but didn’t—as having been inspected. Most often, such a facility was out of business or otherwise not operating at the time of inspection. These non-inspections comprised more than 25 percent of all the facilities FDA counted as inspected.

FDA ‘Cop-Out’

“Attempted inspections occur when an investigator visits a facility but it is out of business or not in operation, but FDA counts those facilities in its inspection numbers related to meeting the mandates,” says David Acheson, MD, a former associate FDA commissioner for foods. “Reading between the lines, I don’t think OIG really approved of that strategy and saw it as a cop-out by FDA.”

After excluding these facilities, OIG says the total number of completed inspections actually decreased over time, from about 17,000 in 2004 to only 16,000 in 2015, despite an increase in the number of facilities coming under FDA jurisdiction. As a result, the proportion of facilities inspected by FDA has decreased substantially over time, from 29 percent in 2004 to just 19 percent in 2015.

Further, the proportion of non-high-risk facilities that FDA attempted to inspect, but didn’t, increased during the first cycle, from 6 percent of the total in 2011 to 68 percent of the total in 2015. Some of these facilities, such as seasonal facilities or those that were closed temporarily, still need to be inspected. But FDA doesn’t have an effective rescheduling policy in place, OIG says.