Difference betwee General vs. Follow-up Inspections

[tallu]

Hello Covers,

Does anyone have participated FDA follow up inspection? Is there any difference if its compared to general fda inspection?

Its been a while since my recent inspection but if I remember right in general inspection investigator goes through whole quality system. Does follow-up inspection have some special form or interests from FDA point-of-view?

Does any one have or remember inspection plan for follow up inspection?

BR
-tallu

 

[Mark Meer]

Check out the FDA's COMPLIANCE PROGRAM GUIDANCE MANUAL: INSPECTION OF MEDICAL DEVICE MANUFACTURERS

In it, it says:
"Compliance Follow-up, For Cause, and Risk Based Work Plan inspections are dictated
by the previous FDA 483 findings and other regulatory information and may differ from
the typical QSIT approach. The inspectional guidance provided by the assignment, the
district compliance branch, and/or CDRH will guide the direction of these inspections.
However, elements of the QSIT Guide may also be utilized."

My (limited) experience with followup is that they are more thorough, and (obviously) have particular focus on areas of previous observations, but they will still (re)examine the rest of the system aswell. Another obvious difference is that followups focus on records generated between the period of the previous inspection and the followup.

 

[tallu]

Thanks Mark!

Does anyone else have any experience to share?

 

[SonjaS]

Hi,
my experience with FDA follow-up audit was the following: they came back to review only the processes and records upon the observations from their previous audit. Previously, they looked for some portions of documentation and records to be provided in advance, again, only in regards to the previous observations.