How does FDA determine OAI and VAI after inspection?

M

medcat

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#1
#1
Hi there,
I'm just curious that after we receive 483 after FDA performed inspection, how does FDA classify the inspection as Voluntary Action Indicated (VAI), or Official Action Indicated (OAI)? Is there certain criteria?
And how does FDA decide if this would lead to warning letter?
Is there some guidance on this?
 
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