NOTE: THIS POST IS OUT OF DATE AND THIS IS A LEGACY PLATFORM THAT IS NO LONGER IN USE.
When the FDA notifies you of an upcoming inspection, sometimes you only have minutes to prepare. You need information, and you need it fast.
Most companies start with a Google search or call their friends and colleagues to get information about their inspector.
But with FDAzilla, you have more than anecdotes. You have real statistics.
FDAzilla has detailed profiles on over 4,000 FDA inspectors, including every inspection, citation, and enforcement action they’ve ever issued.
In this post, we will walk through an FDAzilla inspector profile — a snapshot of the inspection and citation history of one of the 4,000+ FDA inspectors in our database.
In addition, we will review how to search and access 483s, EIRs, and warning letters linked to your inspector. And we will analyze inspector tendencies by keyword category.
To continue, either watch the video below or continue reading.
Let’s Get Started
To start your inspector research, type in the inspector’s name in the investigator tab.
As an example, let’s look at Thomas Arista, a senior FDA inspector who has performed hundreds of inspections around the world.
Select his name to load a quick snapshot of his history.
He’s performed 144 inspections and issued 137 FDA 483s. If you get inspected by Thomas Arista, you’re probably going to get a 483!
But he’s only issued 3 warning letters, which actually puts his warning letter issuance rate significantly below most other senior FDA inspectors.
FDAzilla has 35 of Thomas’ 483s in stock.
He only performed 2 inspections last year and none this year.
Here you can see all the co-inspectors and protégés that have worked underneath him. And to the left is a quick summary of his CFR citations:
To look at all the 483s, sort by 483. To look at all the EIR’s, sort by EIR. And to look at his three warning letters, sort by warning letter.
Select the ‘Go to Inspection’ button at the top of the page to see every inspection that Thomas Arista has done. Our data goes all the way back to the year 2000 when he performed his first inspection and continues up to his most recent inspection on August 17th 2017.
You can then select the button under “Warning Letter” to look at the warning letter.
Now, let’s look at an inspection he performed on Claris Injectables. No warning letter was issued, but there was a 483. Let’s look at the inspection record.
This is a quick summary of what the FDA found on that inspection. Method validation, media fills, data integrity, and many other concerns. There were 18 observations on the 483. FDAzilla has re-typed all the 483s, broken them into individual observations, and tagged each observation. This first observation is about electronic records and environmental monitoring. The next observation covers document control and backdating.
If you want to look at inspector tendencies, FDAzilla has another report that can help you do a deep dive.
Type in Thomas Arista and select inspector. Here are all 144 of Thomas Arista’s inspections. Scroll down to see which sites he has inspected the most, which ones received 483s, and where he issued his three warning letters.
You can also sub-segment this report. Select Human Drugs, United States, and India to only see Thomas Arista’s inspections of human drugs in the United States and India.
He’s performed 62 inspections that fit these filters. You can then see the sites he inspected and the CFR citations he’s done for those facilities. Next click on one of the CFR codes to see the inspection.
Let’s take off that filter and go back to look at his keyword citations. If you care about data integrity, you can sub-segment the 22 inspections where FDAzilla has records of data integrity.
To go further into that, select Hospira Rocky Mountain to look at the CFR citations and the 20 observations that Thomas Arista found.
Wrap Up
In this post we showed a snapshot of one of the 4,000 FDA inspectors who have done an inspection since the year 2000. In this case, we looked at senior inspector Thomas Arista who has performed over 100 inspections on behalf of the FDA and issued 3 warning letters. We showed you how to sort through FDAzilla’s entire corpus of documents – which includes 9,500 483s, 15,000 warning letters, and over 3,000 EIRs – to dig into the data that pertain to that inspector. And we also showed you how to deep dive into inspector tendencies around keyword items like CFR trends and data integrity.