How Does the Government Shutdown Impact FDA Inspections?

Half Open, Half Closed

The government is still shut down, though the FDA is still about half-open.  The question is: which half?

The government shutdown is now on day 9, with no end in sight. Based purely on our 483 sales data in the last 9 days compared to September data, we’re seeing a significant drop. It makes sense that FDA inspections have either slowed down significantly or stopped completely. It was reported earlier this week that 45% of the entire staff would be off.

This will obviously impact all FOIA requests as well – I’d expect requests to take 3-4x the norm.

There were also reports earlier this week that “routine” FDA inspections of food facilities have been suspended, with apparently 60% of its inspectors on furlough. The report goes on to say that food investigators are prioritized inspections based on public need and “are being deployed in response to recalls.”

The FDA has been directed to prioritize in the following way: “activities related to medical products will be limited to excepted work involving the safety of human life or the protection of property.”   Not surprisingly, inspectors of food imports were mostly still on task, with 344 inspectors still working, and only 77 on furlough.

What’s the most interesting to me is that the article seems to suggest that FDA inspectors, once the government shut-down has ended, will still be expected to conduct those routine inspections.  Would it be too far-fetched to conjecture that these next round of routine inspections will be a little more lenient?  Maybe instead of a 4-day inspection, it becomes a 2-3 day inspection?  Nonetheless, in no way does this mean to let down your guard.

When we get in the inspections data, we’ll have a clearer picture of what’s really going on.  As you can see, the FDA is definitely already on pace for a slower year in terms of inspections and 483s.

Note that there is a bill on the table to fund the FDA to support food safety programs.

Luckily, we aren’t impacted by the shutdown! Get any of 2,300 FDA 483s on our 483s store.

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2 thoughts on “How Does the Government Shutdown Impact FDA Inspections?

  1. Anonymous

    My firm received an FDA Inspection just prior to gov’t shutdown. The inspection was supposed to last 6 -7 days, however, it only lasted 2.5 days. While our firm was well prepared, which likely contributed to the shorter inspection, post inspection, the FDA inspector informed us that the goal was to complete this inspection prior to quarter end and commented on the impending shut down, indirectly suggesting that they needed to complete this inspection prior to the shutdown ! Go figure ! I wonder if the budget shortfall could start forcing some further automation and inspection efficiency improvements? Just a thought !

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  2. Pingback: Top 5 FDA 483/Warning Letter/Inspection Stories of 2013 | FDAzilla Blog

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