What to do Before and After an FDA Inspection

[Ronen E]

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

Scroll up to my previous post to find a link to FDA guidance / overview of the subject.

Cheers,
Ronen.

 

[Ajit Basrur]

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

Refer Establishment Inspection Report

 

[sagai]

Aphel,
I have went through this thread and I think I would put my two coins.

1st ... relax !
I do not think if you could really change your world having a couple of days, I would rather suggest to get some spirit a bit closer to your senses.

If you look for non conformities raised as part of the FDA audit, there is a public search engine to be used:
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/default.htm

Actually, I am receiving regular update, you also can subscribe for free.

But again, it is a kind of continuous thing to do rather than a one time inspection preparation, in order to be effective.

Cheers and good luck!

ps.:
spirit is also a sound idea after the investigation

 

[Aphel]

Hello,

for communication purposes... what kind of methods are allowed to ensure communication between the inspection room and the back office?

Is ist allowed to install a video live stream between those rooms?
If not - why not?

Many thanks in advance,
Aphel

 

[Wes Bucey]

Hello,

for communication purposes... what kind of methods are allowed to ensure communication between the inspection room and the back office?

Is ist allowed to install a video live stream between those rooms?
If not - why not?

Many thanks in advance,
Aphel

Of course you can install live video [and sound] anywhere in your operation. The question is: "Does it provide value to your operation?"

For example, if the video is like a "Big Brother" spy system, don't consider it unless you feel EVERYBODY is untrustworthy. If it is to improve communication, what, exactly, is accomplished by video versus phone and email [even Skype, if necessary]?

Information and data can always be posted to either an in-house network, or, increasingly, the Cloud, for instant retrieval when and where required.

If you are only doing the video feed to facilitate the FDA inspection, don't waste time or money.

 

[HPLC_Help]

Aphel -

I would be interested in knowing how the inspection went.

H_H