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Govzilla is the only complete source of FDA inspection and enforcement data that is compiled into one database, keyword tagged, and searchable. You can use this unique dataset to quickly and easily create CFR trend reports filtered by Sub-Section, Region, FDA Center, and even your own Suppliers.
Watch the video or follow the steps outlined below to learn how to do a CFR Trend report using the Govzilla platform to run reports on citations for combination product inspections.
In Macro Trend Reports, under Report Type select CFR Trends By Sub-Section.
Select Last 3 Years under Date Filter. That’s 2016 to 2018. To also include 2019, select Current And Last 3 Years.
Under CFR Part in Optional Filters select See More and then 21 CFR 820 which is medical devices.
As you can see, there are a lot of other CFR citations. In fact, FDAzilla has every CFR citation issued by the FDA since the year 2010.
Now click done to view the results.
Now, for example, select North America from the Region filter on the left navigation.
Now click the Apply button to see the report.
What you see now is 21 CFR 820 – medical devices – in North America in the last three years.
At the top of the report are the filters that we chose.
Here are the citations by year.
And the total is 7,728 citations.
You can download this data in CSV format and turn it into charts if you want to.
To get to combination products scroll down the page to see the inspection records.
As an example, try to find when 21 CFR 211 was also cited.
Select the icon next to Citations and type 21 CFR 211 into the search bar.
Here are all the inspections that were cited with both human drugs and medical devices, which is a proxy for combination products.
When you are finished with your search, you can download all this data as a CSV file for further analysis.
That completes our example of how to use the FDAzilla platform to create CFR Trend Reports.
As you saw in this example, you quickly and easily tunneled in to see what the FDA is actually citing on combination products.