October 2, 2017

Increasing inspections under FSMA pose problems for FDA

A recent report says that the FDA is on track to meet the inspection timelines in the Food Safety Modernization Act (FSMA), but problems might arise as those timelines become tighter in the future and in the meantime the agency is facing other problems with food inspections.

The report by the Office of Inspector General at the U.S. Department of Health and Human Services said outdated information is leading the FDA to try and inspect facilities that are, in fact, not in operation.

That is among the reasons why the number of facilities that the FDA inspects has actually fallen in recent years.

“Although FDA is on track to meet the FSMA inspection mandates during the initial cycles, the overall number of food facilities that FDA inspected since the passage of FSMA has decreased from a high of about 19,000 facilities in 2011 to just 16,000 facilities in 2015,” the report reads.

In addition, when the FDA found violations its actions were not always timely and didn’t always fix the problem. The report found the agency consistently failed to conduct timely follow-up inspections to ensure that facilities corrected significant violations.

“For almost half of the significant inspection violations, FDA did not conduct a follow-up inspection within one year; for 17 percent of the significant inspection violations, FDA did not conduct a follow-up inspection of the facility at all,” according to the report.

In future inspection cycles, the timeframes that FDA is required to meet are shorter by two years.

While the FDA has demonstrated it has the ability to meet the shorter timeframes for high-risk facilities, for non-high-risk facilities, the shorter timeframe poses a challenge for future cycles.

FDA either inspected or attempted to inspect an average of 8,125 of these facilities per year from 2011 to 2015. If that number stays approximately the same, FDA would have to inspect at least 12,000 each year to inspect all non-high-risk facilities within a five-year inspection cycle. Unless it increases its current pace of inspections of non-high-risk facilities, the report warns the FDA will not be able to meet the mandates for future inspection cycles.

Recommendations from the Office of Inspector General 

The office recommends that FDA:

  1.  Improve how it handles attempted inspections to ensure better use of resources
  2. Take appropriate action against all facilities with significant inspection violations
  3. Improve the timeliness of its actions so that facilities do not continue to operate under harmful conditions
  4. Conduct timely follow-up inspections to ensure that significant inspection violations are corrected. FDA concurred with all four recommendations.

“We value the steps FDA is taking to address the recommendations and look forward to FDA providing more information in its Final Management Decision,” the report said. “In particular, we appreciate FDA creating new procedures for establishing a reschedule date for facilities it attempted to inspect and a tracking system to monitor facilities that warrant further action.”

However a report by food industry analysis website Food Dive found it will be challenging for  the FDA to meet the tightened inspection timelines under FSMA without significant increases in staff and funding, which seem unlikely given that the Trump administration has proposed a fiscal 2018 FDA budget of $1.89 billion in direct government funding, which is $854 million less than current levels — a 31 percent cut.

“It will be a tough sell if the agency tries to justify a higher domestic food facility inspection budget when — as the report indicates — it has done less and less in the past few years with what it already has,” according to Food Dive.




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