Regulatory: FDA Warning Letter General Trend

Over the past few years I have been reading every warning letter published by the FDA and adding them to a database. I now have a database of more than 3000 warning letters, with metadata such as company type, whether it is CSV relevant, which parts of 21CFR are cited, whether it is a foreign or domestic inspection, etc.

This data can be analysed to detect trends and correlations arising fro FDA inspections.

I will be publishing my analysis of the FDA Warning Letters regularly.

Let's start with a simple analysis: How many warning letters are the FDA issuing every year?

This graph shows the total warning letters issued across all industries as of 23-July-2008. So the 2008 figure is much lower since the year is just over half finished. However, as we can see it has been dropping continuously since 2004, and 2008 is on course to follow this trend.

Combine this with a recent press report stating that the FDA is looking to recruit something in the region of 2500 new staff, and I think we can see that the FDA is not able to perform as many inspections as they once could.