• You asked for it… Wanted more review of the
• This series is designed in parts
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 1 – Preparing for the FDA
People always ask me – “Troy, what is the best way to deal with
FDA issues?” I usually say…”Don’t have any”
That being said…there are things you can do to mitigate the
potential for you and your firm to have any serious FDA
Let’s start with the obvious:
• Did you have previous 483’s or Warning Letters? If so, did you
do everything to which you committed in the response? If
not, did you inform the FDA of the delay. During the audit is
not the time to find out you have issues…
• Will the next audit be – general GMP? For cause? PAI?
• If the inspection is going to be focused – you can focus your
attention to getting those things ready. Don’t forget – you
could always have a general inspection even during a PAI.
Your facility should always be ready for an inspection! But…it is
always a good idea to go through the facility to see how things look.
• Working in the factory every day can “dull” your senses to
problems that might have slowly developed over time
• Have someone “new” go through the facility
• Develop a “tour” plan for the areas – who will lead the tour in
different areas? What pathway to take (just remember – the FDA
can always go where they want – within reason)?
• Any signs of leaks in the ceiling? Cracked walls? Pealing Paint?
• All signage in place?
• Facility registration up to date?
• How does the exterior of the facility appear?
• Remediate anything possible!!
• Key is that everything should look organized and in CONTROL!
Look at how you are making the product(s) – specifically on the high
risk processes. If you have a PAI, focus on the product in the filing.
Are you in CONTROL?
How do you know?
Does the process match what you have filed?
Do the SOP’s conflict with the process?
Is your APR (annual product review) process up to date?
Have you maintained a good change control system?
Are people trained?
How do you control training – updates to SOPs?
Annual GMP training performed?
How do batch record errors look? Lots of errors or fairly clean?
Do the investigations often site “people” as the issue? If so,
then you have an issue.
Who are the folks that you will use as SME’s?
You need to check a lot of other items in preparation for the audit.
You know your system – check those areas that have potential for the
Validation – equipment, process, cleaning, utilities, etc.
Pest and rodent control
The key? Show you are in CONTROL!! How do you know it?
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Thanks for watching!