THIS POST IS OUT OF DATE AND BASED ON A LEGACY PLATFORM
Want to learn how to do a keyword search in FDA warning letters? Watch the video or read the post below:
We have about 15,000 warning letters in our database. You can search on any term or combination of terms in any of these documents.
As an example, I’m going to search for “media fills”:
- Make sure you are in the Warning Letters search area by clicking Warning Letters in the left navigation area.
- Type media fills into the search area.
- Click the search icon on the right.
Now we can see that there have been 60 warning letters where “media fills” was listed in an observation.
To take a closer look, click Date Issued to sort by date.
Then, click on the top one ARJ Infusion Services.
What you see next is the actual text of the Warning Letter.
You can do a free search for “media fills” by clicking Ctrl + F. By doing so, you can see where our search term appears in the document.
But if you wanted to know more about this particular site, you can simply click the Inspection Details button.
Once you click that button you are taken to the inspection record where you can find:
- Inspection location
- Name(s) of the FDA Inspector(s)
- FEI number of the site
- Inspection Scope
- Inspection Classification
On the right, you will see the Keyword Analysis we’ve done on the 483. And you see that “media fills” are issued or mentioned in observation 1 of 3.
But many other issues were also encountered on that FDA inspection and listed in that 483. You can highlight those additional keywords by clicking the “highlight” box.
But to focus on “media fills”, just make sure all of the other keywords are unselected.
Also worth mentioning is the fact that this has all been retyped so that you can copy and paste in and out of this document, unlike a standard FDA 483.
Do you have a particular keyword that you would like to look up or are you interested in finding out more about a particular site? Schedule your personalized screenshare demo today.
About the Author
Michael de la Torre is the CEO of Govzilla.
Subscribe to Redica Insights
Get quality and compliance insights from our experts in your inbox