Jay Sjerven

The Office of the Inspector General of the Department of Health and Human Services recently issued a report voicing concerns about the Food and Drug Administration’s ability to meet future mandated food facility inspection schedules and criticizing the agency’s response once inspections reveal significant safety violations.

“At a high level, this report does not make the F.D.A. look good and should create a ‘watch out’ to industry of what the F.D.A. is likely to do in response to the report,” David Acheson, founder and president, The Acheson Group, cautioned in his review of the report.

The report, titled “Challenges remain in F.D.A.’s inspections of domestic food facilities,” outlined major areas it said the agency must address.

The O.I.G. acknowledged that the F.D.A. was on track to meet the initial inspection deadlines as required by the Food Safety Modernization Act of 2010 (FMSA) but saw problems ahead.

F.D.A. inspection
Under the FSMA, the F.D.A. was told to develop a list of high-risk food facilities and a list of non-high-risk food facilities.

Under the FSMA, the F.D.A. was told to develop a list of high-risk food facilities and a list of non-high-risk food facilities. The F.D.A. was directed to inspect each high-risk facility at least once during the initial five-year inspection cycle (2011-2015) and then at least once every three years in subsequent cycles. The F.D.A. was required to inspect each non-high-risk food facility at least once in an initial seven-year inspection cycle (2011-17) and then at least once every five years for subsequent cycles.

The O.I.G. said by the end of 2015, the F.D.A. had inspected, or attempted to inspect, all but nine of the 21,086 facilities on its high-risk list. It also had inspected two-thirds (40,623) of the facilities on its non-high-risk list. The O.I.G. said the F.D.A. seemed on track to complete its initial inspections of non-high-risk facilities by the end of this year. The O.I.G. also indicated the F.D.A. should be able to complete inspecting the high-risk facilities during its first regular three-year inspection cycle (2016-2019).

But the O.I.G. warned with regard to the non-high-risk facilities, “F.D.A. either inspected — or attempted to inspect — 8,125 facilities per year from 2011 to 2015. If the number of non-high-risk facilities stays approximately the same, F.D.A. would have to inspect at least 12,000 each year to inspect all non-high-risk facilities within a five-year inspection cycle. Unless F.D.A. increases its current pace of inspections of non-high-risk facilities, it will not be able to meet the mandates for future inspection cycles.”

The O.I.G. also found the F.D.A. did not always take appropriate action when its inspections uncovered significant safety violations, those classified as “Official Action Indicated.” When it did take action, it commonly relied on facilities to voluntarily correct the violations.

“Moreover, F.D.A.’s actions were not always timely nor did they always result in the correction of these violations,” the O.I.G. observed. “Further, F.D.A. consistently failed to conduct timely follow-up inspections to ensure that facilities corrected significant inspection violations. For almost half of the significant inspections violations, F.D.A. did not conduct a follow-up inspection within one year; for 17% of the significant inspection violations, F.D.A. did not conduct a follow-up inspection of the facility at all.”

The O.I.G. said the F.D.A. must take appropriate action against all facilities with significant inspection violations, including administrative or judicial actions if they don’t voluntarily and promptly address those violations. The O.I.G. reminded the agency of its new administrative authorities under FSMA, which include the authority to suspend the registration of a noncooperating food facility.

The O.I.G. said the F.D.A. must improve the timeliness of its actions, including warning letters, so that facilities do not continue to operate under harmful conditions. The agency also should conduct timely follow-up inspections to ensure that significant inspection violations are corrected.

The O.I.G. said the F.D.A. concurred with the findings of the report.

“We can expect F.D.A. to come down very hard on facilities that have violations and to follow up aggressively,” Mr. Acheson said in reviewing the report. “Likely some companies will be made an example to get everyone in line. Maybe we will see more suspensions of registration — I would not be surprised. But to all those reading this, my message is that if F.D.A. inspects your plant and issues you a 483 (Form 483, a letter warning of violations that must be corrected), you have to pay very, very close attention to addressing the issues that the regulators found. If you don’t address the 483 issues, then you may be the ‘example’ they will focus on.”