THE FDA HAS HAD A BUSY 15 YEARS

15 Years of FDA Inspection Data: Infographic Up until recently, it has been difficult to get data on FDA inspections. Sure, the FDA publishes aggregate data every year, but what about the granular data on every inspection? Over the past year, we’ve worked to get at this data and published this first infographic focused on FDA inspections. Subscribe to our weekly newsletter for regulatory and quality insights and developments. As you might imagine, the FDA has had a busy 15 years. Over that time period, they conducted 600,000+ inspections spanning 150,000+ facilities, issuing 130,000+ FDA 483s, and utilizing 4,500+ inspectors. THE MIX OF FDA INSPECTIONS HAS CHANGED DRASTICALLY Looking at the inspections year by year, FDA has gradually ramped up the number of inspections each year, starting at around 30,000 in 2000, and peaking at 46,000 in 2011. 483s issued roughly mirrored that trend as well. Inspection duration has roughly stayed at about 3-4 days, though 3.8 days in 2014 was an all-time high. This could potentially be due to the increased focus on international inspections, which have tripled over the last six years. This is possibly the key take-away from this infographic. International inspections remained constant – at around 800-900 from 2000 to 2008. An obvious, intentional shift in strategy began in 2009, which corresponds to a changing of the guard (Commissioner Hamburg took over for Commissioner Eschenback). Nonetheless, this is not a surprise, as the FDA has publicly announced this increased intensity overseas to match the volume of pharmaceuticals manufactured overseas. We have seen this very clearly in our business as well. More and more of our customers are coming from overseas, as they prepare for their FDA inspections, sometimes for the first time. Just last week, customers from Turkey and Taiwan contacted us on the same day. FDA INVESTIGATORS: LOTS OF VETERANS & ROOKIES Looking specifically at the inspector data is also quite interesting. Out of the 4,500 inspectors utilized over the last 15 years, only 1,500 are active. That means 1,500 inspectors have inspected at least one facility in the last 12 months. As we looked at this data, it seemed that many of the inspections from 2000 to 2005 utilized inspectors that only inspected one facility. Perhaps the FDA transitioned strategies to dedicated inspectors as time passed. These active inspectors have inspected an average of 122 facilities. Despite a massive hiring surge of new inspectors, there is still a large contingent of very experienced inspectors in the field – almost 750 inspectors have inspected at least 101 facilities. There are also a lot of “rookies”, with 177 inspectors with 4 or less inspections under their belts. Of course, these rookies are getting mentoring and in-the-field training from their more experienced counterparts. All in all, we expect to see the FDA continue to ramp up international inspections, using their most experienced inspectors to lead those inspections. What do you see in these numbers? All of this data is interesting for an infographic, but the true value lies in the specifics. We have all this granular data about inspections linked with inspectors, sites, 483s, and warning letters.