This document outlines the steps to take during an FDA audit closeout. When the closeout is nearing, inform senior management and decide who will attend the closeout meeting in an appropriately sized area. During the closeout meeting, listen for any commitments made and take detailed notes. After the inspectors leave, verify all documentation is accounted for. Once resolved, thank the audit team and consider allowing time off. Pass observations to management and prepare to respond within 15 days.

1. Part 4 – Closeout

2. • You asked for it… Wanted more review of the
steps involved
• This series is designed in parts
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Part 1 – Preparing for the FDA
Part 2 – What to do when the FDA arrives
Part 3 – What to do while the FDA is there
Part 4 – What to do during closeout
Part 5 – What to do with the 483
This is Part 4 –
What to do during closeout

3. When you see that the end of the audit is
nearing:
• Inform senior management – I always
recommend that senior management be
present at the closeout
• Decide who will attend – DO NOT have
everyone there! Only the key players.
Typically, management staff level in QA, OPS,
RA – maybe Validation, QC
• Have an appropriately sized area ready – if an
area other than the audit room where you’ve
been working

4. If all goes well – great!
If you get a 483 – trust me, it’s not the end of the world but you will
need to address the situation quickly and skillfully
Determine how you will respond in the closeout
• Remember, if you make commitments during the closeout, you will
be held to those items
• Highly recommend that you state you will review the
observations, make decisive changes and respond within the
allotted time frame
Take notes – you will get the FDA 483 but you want to note anything
discussed during the closeout, especially from the inspector
Correct any errors

5. Once the inspectors have left the building, you have
to clean up the documentation
Verify everything is reconciled – if it was brought
in, you still have it or have returned it
Gather all notes and copies – don’t throw anything
away until you are positive everything is accounted
for and the situation is resolved.

6. Your team has worked hard – give thanks where it is
needed
You may even consider a day off if the audit was
long or intense
Pass along the observations to management and
corporate – be prepared to have conference calls or
meetings to discuss the situation
Remember…you have 15 days to respond to the
observations

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Thanks for watching!