Today I’d like to show you how to do supplier monitoring and benchmarking using FDAzilla Enforcement Analytics.
We’ll start with a simple example of API manufacturers located outside of the United States.
[NOTE: Don’t have access to FDAzilla Enforcement Analytics? Get your personalized CMO/Supplier Assessment using the techniques discussed in this article here.]
To get started, go to Sites and type in a Site Name that you are interested in learning more about — I chose Wockhardt. Click the search icon and wait for the results.
Under your search bar you can see that Wockhardt has 9 sites that have been inspected by the FDA.
Next, we want to create a Group of all the Wockhardt sites. You can either check all or select the boxes individually. Once you have all the sites you want included in the group selected, click the Add to Group button.
Once you click that button, a new window pops up. I already created a group called API Manufacturers that I’d like to add Wockhardt to. To do that:
- Click the Create New button
- Enter “Wockhardt” as a Label Name
- Check the Nest Label Under box
- Choose the group “API Manufacturer” from the drop down menu
- Click Save
And now that I’ve created that group, there’s a lot of stuff that I can do with it.
Let’s look at the API Manufacturers in Wockhardt. You can see the sites that I have saved — Sandoz, Teva, and Wockhardt.
By selecting a group you can go through and see all of the sites, associated inspections, and so on.
Now, let’s investigate Wockhardt’s inspections by clicking on the Inspections tab.
FDAzilla has every inspection since the year 2000. As you can see, Wockhardt hasn’t been inspected since 2016 and their last warning letter was received in 2015.
Note that with a subscription to Enforcement Analytics, you can create your groups and put all of your suppliers in there. We will automatically go get the 483s and link the warning letters on any supplier that you say that you want to follow.
Now, we want to compare the suppliers to one another. Some questions that can be answered by Enforcement Analytics are:
- How do your suppliers compare?
- Are all of their 483 issuance rates the same or are their warning letter issuance rates the same?
- What’s the difference?
Begin by going to the Benchmarks area on the left navigation area. Select:
- Your suppliers (in this example, the “API Manufacturer Group” we just created)
- FDA Industry (I selected Enforcement Actions for Human Drugs)
- Date Range (I chose the last 5 years)
And so what do we see here?
To take a better look, I sorted my columns by Warning Letter Issuance Rate.
*Note that WL Issuance Rate is calculated from the number of 483s received.
You can see that Wockhardt has had 10 inspections in the past 5 years that resulted in 8 FDA 483s and 2 warning letters, giving them a 25% WL Issuance Rate.
As for Teva, they have had 65 inspections in the same amount of time resulting in 25 FDA 483s and 2 warning letters as well — bringing their WL Issuance Rate down to 8%.
Sandoz is doing better than both, with zero warning letters in the past 5 years.
Deep Dive Into Inspections
Finally, I’d like to do a deep dive and see what was going on with Teva’s inspection that resulted in a warning letter.
To do that, I type in “Teva” in the Inspection Details search area to get a sub-segment of all the inspections from this table.
Next, I sort by Warning Letters to bring the latest WL to the top of the table.
And then I can click on an individual inspection and see the issues associated with that inspection.
So, in this case, there were 12 CFR citations. You can see a list of Keyword Categories that were cited on the right.
And then we can step through and look at each of the 11 observations that were cited on this inspection.
Every 483 in our database is keyword tagged and highlighted for your ease of comparison, as you can see here.
So you can layout different suppliers side by side, see their 21 CFR citations, see what keyword issues they are having, etc. You can even compare that to what you are finding on your own supplier quality inspections.
Want to see what else we can do with FDAzilla Enforcement Analytics? Check out our Video Tour here.
About the Author
Michael de la Torre is the CEO of Govzilla.