Avoid a CAPA File Inspection Disaster

Avoid a CAPA File Inspection Disaster

March 13th, 2013 // 2:44 pm @

March 18, 2013

We had a very informative webinar with Dennis Moore, AUK Technical Services, this month on surviving an FDA inspection….lots of interesting war and horror stories, things to do and not do. We also have this interesting Webinar coming up on how to design a closed-loop CAPA system.

One that was interesting to me was Dennis’ points on CAPA files during an FDA inspection. As with many screw ups during an FDA inspection, this might seem really obvious, but it’s a good idea to make sure your CAPA files don’t look like this:

When it comes time for you to present some of your CAPA files to the investigator, please make sure that you have everything clean, neat and organized. Dennis recounted his days as an FDA investigator when quality managers would hand him a CAPA file with papers falling out and Post It Notes stuck everywhere. If the investigator asks to see some CAPA files, please make sure they don’t look like this!

However, interesting point he made – some smart FDAers will not allow you to present to them a cleansed CAPA file of your choice. Some will walk to your CAPA area and pick out one themselves. So, you will not have the opportunity to give them one cleaned up sample. In this case, you have to make sure that your whole CAPA filing system is nice and orderly.

If you do have the chance to grab a few CAPA files of your own choice, Dennis warned: Do NOT have your cleansed files sitting right there on the table for the investigator when he arrives. No, have someone go out of the room and get the folders from your inspection ‘war room.’ He advised that you have a conference room set aside specifically for the purpose of organizing records for the inspection, which he called ‘the war room.’ You go off to your war room and get what the investigator wants. This avoids giving the impression that you cleaned up a few files for the investigator.

For more really useful CAPA tips, including how to design a closed-loop, FDA-compliant CAPA system, be sure to check out our upcoming Webinar.


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