For decades, global pharmaceutical and fast-follower companies have been building new plants in Asia to take advantage of inexpensive labor and developing global markets. We have been ingesting medicines made in China and India for a long time. Very few of them were ever inspected by the FDA.
As you can see from data obtained from FDAzilla’s Enforcement Analytics database, the FDA has made a planned, drastic shift of resources to reflect this manufacturing reality. International inspections have gone from 1,520 in 2010 to 3,140 in 2014 – a doubling in four years – with the lion share of these in Asia.
(This chart is part of a larger infographic on FDA inspections that you can view here)
This trend should continue through 2017, when the FDA is mandated to inspect generic manufacturers as much as their branded counterparts. With inspection intensity rising this quickly, who is the person spearheading these inspections?
One prominent investigator is Peter E. Baker. If you run a manufacturing plant in Asia, and you get the call that Peter E. Baker is coming to inspect your facilities, watch out.
For those of you who prepare your facility for FDA inspections, you know the drill at this point. Clean up shop. Update records. Study up on “off-the-record” notes about the investigator (and any co-investigators that you know of). Make calls to your network to find out personal nuances, pet peeves, and recent questions about your inspector. Now more than ever, take a deeper look at investigator history data.
With Enforcement Analytics, you’d pull up Peter E. Baker’s investigator profile that shows his key metrics – here’s some screenshots:
Peter E. Baker’s 117 inspections have yielded a whopping 78 FDA 483s. 2/3s of his inspections have resulted in a FDA 483 – about 3x the FDA average.
As you may have noticed above, in a groundbreaking development, FDAzilla has linked inspections data to sites to 483s to investigators to warning letters. So, now you know instantly that Peter E. Baker’s inspections have resulted in 14 warning letters. Many of these warning letters have rocked the company, enough to move the stock price.
Billions of dollars of market cap have been lost because manufacturers did not fix their problems before or after Baker’s inspections.
When you start looking at Peter E. Baker’s full history within Enforcement Analytics, your team would download any available FDA 483s as well as all of his warning letters, paying special attention to the most recent five.
Here’s a screen shot of Baker’s inspection history. Note the PDF icon for 483s we have readily available, and the “YES” buttons on the right that would link straight to the warning letter. Also note that the inspections in red resulted in a 483, while the green ones did not result in a 483.
What aspects did he spend the most time on? Are there themes across his inspections (we all know that he is famous for attacking data integrity problems, as this has been a problem for at least 15 years)? How long are his typical inspections?
How in the world did this last Chinese company escape the inspection without a 483, breaking Baker’s streak of 20+ inspections issuing a FDA 483? Which investigators co-inspected with Peter Baker (for example, Dipesh Shah)? Won’t they also focus in on the same themes?
Access to smart data provides better answers, and more importantly, better questions.
We see a lot of companies come to us for assistance just as an inspection is happening (our real-time data can sometimes even predict where an inspector is going). But more and more companies are doing proactive analysis, preparation, and mock audits to stay ahead of the FDA’s latest areas of focus. It is amazing how sharply resources can be focused when the data shows you what that focus should be.
And as many companies in Asia are finding out, it’s good to know what Peter E. Baker and his co-inspectors are focused on today.