Manufacturing CRL - Class 1 or Class 2 Inspection (FDA form 483)

J

jordan31

#1
Hello All,
I have some Doubt Regarding out come of our form 483 Response submitted to FDA. CRL was related to deficiencies in manufacturing process and controls .

We submitted complete response letter addressing all the deficiencies and also attached FDA district office letter stating we have address all the issues ...

how much chances we receive class 2 inspection vs class 1.. Can FDA give us class 1 approval without re-inspecting manufacturing facility as we attached letter from district fda office..

Appreciate your time ...

Thanx you all....
 
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