Regulatory Focus™ > News Articles > When FDA Comes Calling, Do US Companies Fare Better Than Others?

When FDA Comes Calling, Do US Companies Fare Better Than Others?

Posted 17 November 2014 | By Sharon DeGrove Bishop, RAC

When FDA Comes Calling, Do US Companies Fare Better Than Others?

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Last month we explored the rates of US Food and Drug Administration (FDA) inspection conclusions for registered establishments within the US [When the FDA Inspector Comes, What are the Chances of a Really Bad Outcome?]. Several readers posed questions about international inspections, so in this issue we’ll take a look at FDA inspections on a global scale.

Here’s a brief recap of the three possible District Decision conclusions based on FDA’s review of the inspection results:

  • NAI - No Action Indicated (either minor or no objectionable conditions)
  • VAI - Voluntary Action Indicated (only minor objectionable conditions)
  • OAI - Official Action Indicated (significant objectionable conditions that warrant FDA sanctions)

Using The SOFIETM System for Regulatory Intelligence, we investigated the frequency of occurrence for each of these conclusions for the years 2009-2013, for Outside US (OUS) and US inspections. These are inspections of all FDA-regulated industries including drugs, devices, biologics, veterinary, food and cosmetics.

The two charts below show the number of facility inspections for OUS and US:

Outside-US Inspections by FDA

US Inspections by FDA

As we might expect, it’s clear that the FDA conducts many more inspections within the US by a factor of 10. But we also see that while the number of inspections in the US peaked in 2011, for OUS the number has increased significantly in the past three years. This could reflect an increasing number of foreign manufacturing facilities, or perhaps increased resources dedicated to OUS inspections, or both.

Now let’s look at the percentage of inspections with each of the three conclusions for both OUS and US.

Outside US Inspections by FDA - Percentage

US Inspections by FDA - Percentage

We can see a couple of things from these charts:

  • The rate of inspections deemed OAI is considerably higher OUS
  • Inspection results for both OUS and US are improving over time
  • There is a higher ratio of VAI to NAI for OUS

Over the next few months we will explore inspection results in some particular countries, and also delve into the most frequent citation notes.

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