Regulatory Focus™ > News Articles > Guess Which International Medical Device Facilities are Most Likely to be Inspected?

Guess Which International Medical Device Facilities are Most Likely to be Inspected?

Posted 08 January 2015 | By Sharon DeGrove Bishop, RAC

Guess Which International Medical Device Facilities are Most Likely to be Inspected?

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Let’s say you have responsibility for international facilities in Germany, China and Costa Rica, and each one is due for an inspection – you just don’t know which one would be the most likely to be inspected. With limited resources (as most of us have nowadays), how do you use regulatory intelligence to decide where to send your auditors first to ensure you’re prepared?

You can review the FDA data on where they have conducted recent inspections, but this only gives you part of the picture. For our three countries in 2013, here is the number of inspections that FDA conducted in each:

Number of FDA Inspections 
Germany 71
China 60
Costa Rica 35

Based on this, you might expect that Germany would be the most probable candidate. But if you want to determine the likelihood that a facility in a particular country will be inspected, you need to know how many registered establishments there are within that country. This provides the denominator for you to calculate the percentage of establishments that were inspected.

Using the Graematter SOFIETM System for Regulatory Intelligence, we found the number of registered device establishments in each country, so we can see the full picture.

Country# of Registered Device Establishments# of FDA Inspections
Germany 985 71
China 2946 60
Costa Rica 35 8

With these data we can now calculate the percentage of facilities inspected in each country, and we have a whole different story.

GermanyChinaCosta Rica
7% 2% 23%

Looks like the audit team is headed to Costa Rica first! This demonstrates the necessity of ensuring you’re analyzing the right data before drawing conclusions. We can also discern trends if we look at these metrics for prior years. Here are the numbers for 2010-2013.

FDA Facility Inspections by Country

This shows that while the rate of inspections has been fairly constant in Germany and China, Costa Rica has seen a marked increase in the percentage of facilities inspected. 

While we don’t know the reason for this increased focus in Costa Rica, it’s clear that for our scenario, the chance of an FDA inspection is far greater in this country than in either of the others. The takeaway is that you cannot see where the FDA is focusing its inspection efforts by following only one metric.

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