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OIG says FDA needs to boost efficiency to meet federal law

Food and Drug Administration domestic food inspections are “on track” for now, but not for the tighter timeframes called for in the Food Safety and Modernization Act (FSMA).

To read the full report from the OIG, please click on the image.

So finds the Office of the Inspector General (OIG) for the U.S. Department of Health and Human Services (HHS), which has oversight responsibilities for FDA.

In a 35-page report issued this week after a review of FDA inspections of domestic food facilities, the OIG also says the food safety agency “did not always take action when it uncovered significant inspection violations-those found during inspections classified as ‘Official Action Indicated’ (OAI).

* In eight instances, FDA took an enforcement action in addition to an advisory action. Source: OIG analysis of FDA data 2016.

“When it did take action, it commonly relied on facilities to voluntarily correct the violations. Also, it rarely took advantage of the new administrative tools provided by FSMA. Moreover, FDA actions were not always timely nor did they always result in the correction of these violations.

“Further, FDA consistently failed to conduct timely follow-up inspections to ensure that facilities corrected significant inspection violations.”

Source: OIG report September 2017

The new OIG report discloses FDA’s spending on domestic food facility inspections from 2004 to 2015. The analysis of FDA data shows spending on domestic food inspections has dropped off in the years since the passage of the FSMA.

In 2010, the year before President Obama signed the FSMA into law, spending on domestic inspections totaled $137.4 million. It went up to $139.7 million in 2011 but then fell in each of the next four years ending up at $129.8 million in 2015

From 2011 to 2015, the OIG reports FDA took 1,113 “advisory actions.” Those were: 903 warning letters; 136 regulatory meetings; and 74 “untitled letters.”

It took FDA an average of 4.4 months after an inspection to respond to written warnings or meetings. The “untitled” letter took even longer, 6.1 months on average.

FDA took more severe administrative actions only 19 times in five years. Those included 12 import alerts, coming an average 3.2 months after inspection.

Suspensions of food facility registrations were twice ordered, coming 0.8 months after the review. And FDA issued five administrative detention orders, averaging 0.2 months afterward.

FDA sought judicial action 58 times during the period. It obtained injunctions in 37 cases, which on average came 8.9 months after inspection. And after an average of 3.1 months, it won seizure orders in 21 instances.

The OIG report makes four recommendations:

  • FDA should improve how it handles attempted inspections to ensure better use of resources.
  • FDA should take appropriate action against all facilities with significant inspection violations.
  • FDA should improve the timeliness of actions, including warning letters so that facilities do not continue to operate under harmful conditions.
  • FDA should conduct timely follow-up inspections to ensure that significant inspection violations are corrected.

FDA’s written responses are in the IG report, and the agency concurs with the recommendation but also makes some explanatory statements.

It is revising procedures for seasonal and inactive facilities to help decrease the number of times it sends personnel to those sites.

For example, seasonal operations such as small maple syrup producers and companies that have temporarily closed for equipment installation often turn FDA away until a later time. FDA said it recently developed the “Inspections Needing Work Activities” report to better keep track of needed corrections after site visits. It may include where an “Official Action Indicated (OAI).” FDA promises to “more efficiently track compliance activities from OIA inspections for which it is responsible.”

FDA defended the use of its regulatory powers, pointing out that it suspended the registration of SM Fish in September 2016 and Dixie Dew Products Inc. in March 2017. In their response to the OIG report, FDA leaders said they recognize the need to “improve the timeliness of regulatory actions.”

The agency also explained its need to change with the market. It established the Office of Dietary Supplement Programs (ODSP) in 2015 after sales of dietary supplements grew to $40 billion a year, up from just $4 billion two decades earlier. Beyond six months, 65 percent of FDA’s warning letters  addressed dietary supplement concerns.

As for correcting violations, FDA said its goal is “to conduct timely follow-up inspections to ensure that significant violations are corrected.” The food safety agency a “multi-programmatic oversight group” to make sure food makers correct violations.

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