FDA Inspection Preparation Hints

Aphel

Involved In Discussions
#1
Dear all,

Few days ago the company I am working for, was informed by the FDA, that we will have an inspection in March next year.

Our quality system is bulid up according to 21 CFR Part 820 (cGMP) for the last six years. We develop and manufacture medical devices of class 1 and one medical device of class 2 in the USA.

This will be our first FDA inspection (unfortunately it will not be a "for cause inspection"), but we (especially my person) are a little bit nervous about that...

Do you have any good or practical advice for me, how to cope with an inspection in a good way, do you have some hints for preparation, do you know a certain code of conduct regarding inspections or do you have any other guesses derived from your experiences with inspections?

Thank you very very much in advance for your suppoert.

Best regards,
Aphel
 
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C

CBAL08

#2
Re: Preparation for FDA Inspection

Well if you have everything in Place there is nothing to worry about... for example....all procedures and records up to date...do you in addition also have ISO 13485 ? If you have been audited before then there is nothing to worry...all they are looking for is are you in compliance and have you done what yous aid you will do?

All the best....Read QSIT from http://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm074883.htm
 
G

Gert Sorensen

#3
Re: Preparation for FDA Inspection

There are some really good pointers in "The FDA and Worldwide Quality System Requirements Guidebook for Medicl Devices". That is money well spent in this case. Other than that; read the QSIT, it will also give you an idea of how this may progress.
 
J

JaxQC

#4
Wow, March would be great. We only get a (5) day notice.

Just some thoughts to consider. While you can’t tape or record the FDA audit, you are permitted to document it. Have a scribe typing the whole time documenting what is going on, what was reviewed, questions, problems etc. Document form & rev of every piece of paper they walk out with which is also marked as “Confidential”. Otherwise remember that FDA records, as a gov agency, are public record & will be available for everyone to see unless marked as confidential & retracted from the public view.

Use an internal IM (instant message ) type system so that the “back room” can also see what is going on and discuss or provide info to the folks going over items with the auditors. The back room folks also get a heads up on what to grab and have it ready. ie…

Mgr: Auditor 1 is discussing wanting to see training records for the employee talked to at shipping.
(back room gets records pulled & ready for review)
Auditor1: I’d like to see examples of how you implement continuous improvement.
(back room pulls examples, reviews them and turns them into the front room)
When it’s laid out correctly, it works like a dream.
Good luck.
 

v9991

Trusted Information Resource
#5
1) war room idea of JaxQC is pretty good and it really works.
2) QSIT guide CBAL08 is the way to go
also have a look at
http://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm074899.htm
3) have look at warning letters and 483s
http://www.fda.gov/ICECI/Inspections/ForeignInspections/ucm110600.htm

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/default.htm#recent
4) the trend we have seen so far is "compliance" with emphasis on CAPA (improvements...the way they are triggered from various sources such as complaints, incidents, etc., and the way they are closed out)

5) another point i just heard from a trainer is that , FDA started asking for 'why'/ 'justifications'(not just what/how...SOP&compliance)
 
Last edited:
A

Al Dyer

#8
Practical Life??

Take them out for dinner, kiss their behinds and hope for the best. Seriously!

Al...
 

Statistical Steven

Statistician
Staff member
Super Moderator
#9
Practical Life??

Take them out for dinner, kiss their behinds and hope for the best. Seriously!

Al...
Good advice...except they are not permitted to take "gifts" of dinner :)

Seriously, since you have till March, I would hire a consultant to do a mock audit for you. They can help you to prepare, find gaps and most importantly show you how to receive the FDA for an audit...from the front desk reception to back room.

BTW, you should have said FORTUNATELY it is not a for cause audit...those are bad!
 
M

MIREGMGR

#10
Yep, a 90 day advance warning for a For Cause audit would be unlikely. For Cause audits are the ones where they show up at the door and tell you they have legal authority to inspect you Right Now.
 
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