2. You asked for it Wanted more review of the steps involved
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 2 What to do when they arrive?
3. If you know they are coming, you at least have some chance
to prepare Dont let key people go on vacations Keep major activity
to a minimum, if possible Keep a high vigilance on any potential
issues If they just show up, then you have to deal with the
situation. Prepare: Do the guards or receptionists know who to
call? Where to place the FDA? Who will you call? Where will you
host the inspection? White boards cleaned and trash removed from
room?
4. You get the call.they are here! Take a deep breath. Relax.
Call the necessary people management, OPS, QA, QC, corporate, etc.
Get a pad of paper, pen and business cards. Go get the inspectors,
verify that they have signed in to enter the facility and take them
to the meeting room. You will receive a 482 at this point. If the
inspectors dont tell you ask: What is the purpose of the audit?
Where will they go? How long do they anticipate the audit to last?
Can you have review meetings at the end of the day any issues?
Where will they go next?
5. Just like a dance, you let the inspector lead the audit. You
can guide or suggest certain things, but at the end they control
the process. Dont deny them access or challenge their authority
unless They are looking at personnel info (pay rates, reviews,
etc.) Monetary items pricing structure Be friendly and courteous
professional. Take notes what is discussed, answers, who is there,
etc. If they get a copy of something, you get a copy of it.
6. Verify that everyone is aware of the audit Pass along any
information possible to the areas being targeted for the audit
Discuss the timing for the days to come start, stop times; lunch
brought in or will they leave Prepare for lunch for your staff you
dont want people leaving or skipping lunch Pull in the necessary
resources
7. Call us at 513-860-3512 See our website at
www.Compliance-Insight.com Send us an email at
[email protected] Thanks for watching!
