2. • You asked for it… Wanted more review of the
steps involved
• This series is designed in parts
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•
•
•
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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 5 –
What to do with that 483
3. When the audit is over, people typically want to
go home…relax….take a vacation…anything but
deal with the outcome.
You have 15 days to respond (those are working
days)
You now have to get going on the response
• Develop your team
• Have a format for the response
4. You need people to work on the response – and
management has to be involved in supporting you
• People to assess what needs to be changed
• People to write the response work
• People to gather the data
• Management should have a cover letter to the
response
5. You have to resolve the observations systemically
Include copies of any changes made – SOPs, batch
records, etc.
Include training copies as necessary
Address how the product is acceptable (hopefully it
is) – on the market currently, in operations now and
how to control it in the future
6. As you put the document together, have it reviewed
A new set of eyes may have questions that you
didn’t see – working closely to a subject will blind
you to some obvious issues
Serious issues may warrant some legal review
All of these things take time – people have to know
the “drop dead” date for the response to be
finalized.
Delivery – return receipt!!! Copies to all pertinent
parties
7. Call us at 513-860-3512
See our website at
www.Compliance-Insight.com
Send us an email at
info@Compliance-Insight.com
Thanks for watching!