What to do Before and After an FDA Inspection

P

PaulGr

#11
Aphel,

I have some experience with FDA inspections in Europe and I think the comments above are all good and helpful.

Two things regarding preparation are key in my opinion for a successful inspection:
1) Refresh auditee training
2) Perform a mock audit

As an FDA inspection is very different from your yearly notified body audits, it is good to inform management and key staff on the differences and expected behavior. As stated before: you don't want your CEO to start present 30 minutes of marketing bla bla.

A mock audit is not only valuable to identify any gaps but should be used to test your backoffice. How soon can you get the required records? How do you track all the requests of the inspector, how do you get the right people in the backroom, how do you communicate with the front room? Do you show (printed) paper files or electronic records? If you have enough money you can hire an ex-FDA inspector for this mock inspection. Besides, they often know most current FDA inspectors and can give you information about their preferences.

If you are interested, I can give you more details about how I normally setup the back room.

Good luck!
 
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Aphel

Involved In Discussions
#13
Hello PaulGr,

Many thanks for your hints!

Yes, it would be very nice if you could share more experience regarding the preparation of your back-office.
I am grateful for any hints, thoughts, guesses...

Best regards,
Aphel
 
D

Deep Krothapalli

#14
Additional information I can think of now..

1. Make sure that you have point of contact for Primary point of interface in the main room, Escorts, Scribes, Runners, Back Room support, and Communication system
2. Have SMEs, backups, and their contacts for each of the QSR elements. Block their calendars to ensure their availability
3. If you have enough time, prepare inspection SOP, provide training/guidance to everyone involved in the audit
4. Channel all documentation requests through only primary point of contact in back room,
5. Keep a record of all requests and fulfilled. Keep copies of all records reviewed by FDA (whether or not copies are provided to FDA), and note which specific records are copied and kept by FDA. Most Importantly, provide copies of those documents FDA asked for.

Deep
 

Wes Bucey

Quite Involved in Discussions
#15
Right! this may seem obsessive to some, but federal bureaucrats live on paperwork and it can never hurt to have ANYTHING and EVERYTHING on hand they may ask for. It also doesn't hurt to make an inventory of EVERY document the inspector reviews or takes copies of and have him sign off on it so there can be no mistake if HE loses it and claims he didn't get it.

Our guys in the USA claim the best policy is to answer direct questions, but not go off on a tangent beyond the answer.
 

Aphel

Involved In Discussions
#16
Hello!

Thanks to all of you for your advices...

I have one more question.
According to your experience...how many people should be in the inspection room around the table with the inspector?
And how many people do I need in the back office for preparating, copying and bringing documents?

Thanks a lot!
Best regards,

Aphel
 

Ajit Basrur

Staff member
Admin
#17
Hello!

Thanks to all of you for your advices...

I have one more question.
According to your experience...how many people should be in the inspection room around the table with the inspector?
And how many people do I need in the back office for preparating, copying and bringing documents?

Thanks a lot!
Best regards,

Aphel
Except for the Opening and Closing Meeting where there could be more people, the audit sessions typically have Scribe, Escort, Subject Matter Expert and an Audit Manager. The runners will be in and out of the Room. Thus its a max of 4 - 5 persons.

The above sceanrio is depending on 1 FDA Inspector but if there are more, the numbers will be bit more as each Inspector should have 1 Escort.
 

Ronen E

Problem Solver
Staff member
Moderator
#18
If you don't already know it, this could be helpful:

http :// www .fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/QualitySystemsRegulations/MedicalDeviceQualitySystemsManual/ucm122743.htm - OBSOLETE BROKEN 404 LINK(s) UNLINKED
 
Last edited by a moderator:

Aphel

Involved In Discussions
#19
Hello all together,

After fixing the FDA inspection date we now got a notice about the person who will perfom the inspection...

I don't know if this kind of exchange of experience is possible or common, but can anybody tell me something about Mrs. Dorothy W. Lee - she is the one who will come and conduct the inspection.
Is she a strongly evidence-oriented person, does she act very strictly, is it possible to talk and argue with her during the inspection?

Thank you very much for your comments!

Have a nice evening,
Aphel
 

Aphel

Involved In Discussions
#20
Hello all,

I am looking for basic information regarding possible kinds of non-conformities during an inspection...

I have heared about issues with VAI (voluntary action indicated), OAI (official action indicated) and so on...

In what kind of situation do we get a form 483 - in case of VAI, in case of OAI...? I am little bit confused...Can somebody give an overview about that topic??? Or is there any guidance for that???

Thank you very much in advance!

Kind regards,
aphel
 
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