The FDAzilla database contains information on every FDA inspected site since the year 2000, and we continually update our data to obtain the latest inspections and enforcement actions.
All of our 483s and warning letters — over 25,000 documents — are retyped, and keywords are tagged + categorized. This enables you to do full text searches and to also cut & paste the information you need.
In this video demonstration, I’m going to show you how to perform a keyword search of FDA warning letters in our system. FDAzilla has about 15,000 warning letters in our database, and you can search for any term or combination of terms in those warning letters.
To continue, either watch the video below or continue reading.
Let’s Get Started
As an example, let’s search for media fills. There are 60 warning letters where media fills are listed. You can sort by date issued.
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Let’s pick the top one – ARJ Infusion Services. What you see here is the actual text of the warning letter. If you use ctrl-f to search for media fills, you can see media fills are issued right here in the document.
In addition, if you want to know more about this inspection or site, you can simply select Inspection Details or Site Details. Let’s select Inspection Details to see the inspection record.
The inspection record contains information about the site, including the site’s FEI number and the 483 that led to the warning letter.
FDAzilla has produced a keyword analysis of the 483, and you can see that media fills are mentioned in observation 1 of 3. Many other issues were encountered on this FDA inspection. Select highlight to highlight those other keyword areas.
This is the media fill citation in the 483. Unlike a standard FDA 483, the entire 483 has been retyped so you can copy and paste in and out of this document. Using FDAzilla, you can do word searches on all warning letters and on all 10,000 483s that we have in stock.
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Learn more about how FDAzilla can help you achieve your quality and inspection preparation goals: get 483s, Inspector Profiles, Enforcement Analytics, and GMP Regulatory Intelligence. Contact us if you ever have questions at email@example.com.
About the Author
Michael de la Torre is the CEO of FDAzilla.