It has often been said that “the best defense is a good offense.” Believe it or not, this can also be applied to FDA inspections.
“How?” You may ask as the security guard alerts you to FDA Investigator Peter Baker standing outside the gate holding a form 482 announcing an inspection.
(Peter Baker is no longer with FDA but for the purposes of this post, we will pretend he is still an FDA investigator. To learn more about how Redica Systems can help with inspection readiness, click here.)
As you scramble to get your team together, you try to think of discussion points before this hasty meeting. Fortunately, Redica Systems offers data on hundreds of FDA investigators. This can give your team a complete inspection history for your investigator.
Quickly, you open Redica and begin researching Peter Baker using the following five tips.
1. Start with the Metrics
- How experienced is your FDA investigator?
- How tough are they—what is their 483 issuance rate for companies like yours?
- How many Warning Letters have resulted from inspections they conducted?
- Who have they inspected in the last year and what have been the results of the inspections?
After searching Peter Baker by name, you pull up the results using the list view. Here he is at the top of the list.
2. Get a History Lesson
Click Peter Baker’s name. This gives you his inspection history as an FDA investigator. From his history, we learn he has primarily conducted inspections in China. Previously, he inspected sites in India. His concentration is Human Drugs and he appears to focus on data integrity.
3. Review Enforcement Actions
Continue looking at Peter Baker’s inspection history. Fully review his most recent enforcement activities. What does he tend to focus on? Which categories does his 483 observations fall under? Take advantage of our new tagging capabilities.
As mentioned above, he tends to hone in on data integrity. This means you can expect him to ask a lot of questions about data controls and even look through your manufacturing and quality online systems. He will also want to review test data to ensure your site is following good data integrity practices by not conducting retests nor hiding bad test data.
Of course, your site should not be doing that anyway!
4. Filter For the Info You Want
For deeper analysis, filter down. Is your site based in a specific region and produces primarily a specific product? Use these as filters. You can also filter by time frame.
For example, if your site is in the Asia-Pacific region and produces a sterile injectable, you can filter Enforcement Actions in these areas. Perhaps you only want to see his inspections in the last three years. You will now have a list of Peter Baker’s inspections in this region and in this category for the past three years.
5. Go Beyond Redica Systems
We want you to use our system. We are proud of our Enforcement Analytics. Our data is strong. Yet it also would not hurt to do some additional outside research. Contact your colleagues who have been inspected by Peter Baker. Check out his LinkedIn page.
This information will give you a clearer picture of who he is.
Now that you have done your homework, you have a sense of what to expect in your FDA investigation! Continue to use Enforcement Analytics throughout your inspection process as well.
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