J
jordan31
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....
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....
