Monthly Update/ September 2023
www.ipq.org
Monthly Update/Facilities
6
What I want to note here is that this is for registered facilities. You should know that we get lots more facilities registered with FDA than really deserve periodic GMP inspection – a lot of voluntary registrants, anticipatory registrants, companies that think they will get or hope to be in an approved application that does not work out eventually and so actually are not in the US market. That, if you will, skews the inventory higher than true.
But the trend you will notice is increasingly more facilities – a small increase in facilities overseas in general,
increase in facilities overseas in general, but not so much in the EU – for the US market. If we can save 30% of all foreign facility inspections, that could be spent, again, elsewhere in the world. Our risk model is agnostic on geographic location. It does not figure into the model in terms of a weighting factor or selecting factor. That does not mean we will necessarily go only to other parts of the world and not the US. Some of this inspection capacity will come back to the US.
FDA-Registered facilities