Hello,
Few days ago my company got a notice that we will have a FDA inspection in three months...
It will be our first inspection... :mg:
And it will be a "one man 5-day routine inspection"...
Do you have any advices for me regarding preparation activities...?
We already informed us especially about how an inspector conducts during the five days, and we have special SOP for FDA inspections...
But what should we do before the inspection starts:
Contact the FDA to get some detailed information about the person who will come?
Should we try to find out what kind of inspection it will be - level 1,2,3 and so on...?
Should we try to find out somthing about potential inspected products?
And then... what are the right attitudes after the inspection:
What should we do after a VAI?
What should we do after an OAI?
How should we respond to an EIR or a Warning Letter?
Sorry for that many questions... but we want to be prepared as good as possible for this "event of the year" in our company.
Thank you very much in advance for your help and your support.
Have a nice weekend,
Aphel
Few days ago my company got a notice that we will have a FDA inspection in three months...
It will be our first inspection... :mg:
And it will be a "one man 5-day routine inspection"...
Do you have any advices for me regarding preparation activities...?
We already informed us especially about how an inspector conducts during the five days, and we have special SOP for FDA inspections...
But what should we do before the inspection starts:
Contact the FDA to get some detailed information about the person who will come?
Should we try to find out what kind of inspection it will be - level 1,2,3 and so on...?
Should we try to find out somthing about potential inspected products?
And then... what are the right attitudes after the inspection:
What should we do after a VAI?
What should we do after an OAI?
How should we respond to an EIR or a Warning Letter?
Sorry for that many questions... but we want to be prepared as good as possible for this "event of the year" in our company.
Thank you very much in advance for your help and your support.
Have a nice weekend,
Aphel
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