07 Feb

Webinar - Complaint Handling - Best Practices

Answered by- David Lim

Well I think it is up to the Company, in-fact FDA doesn’t say a specific timeline,  it is up to the Company. I have seen a Company open a CAPA for couple of years. For most of quality issues that relate to Complaint. my recommend to try to do it as soon as you can, may be within 2 weeks for some complaints, within a month for some complaints and for some other complaints within 3 months of time .  Because of that developing threshold for some of the events you know what should be considered to open a CAPA, what should be reported to the FDA. So depending upon the severity of the issues then you may set the time, but has to be reasonable. But once you set a time, you have to document and follow it, if you set the time as 2 months and when the Investigators look in the document report and if you have not followed then that will be an issue.

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