Regulatory Open Forum

Can the reg community share the details about:

1. In case of a 180-day manufacturing site change, when does FDA shows up for PAI i.e. after how many days from submission?
2. In case of an original PMA, 
   1. When does FDA come for a PAI i.e., do they come before the 100-day meeting or after the 100-day meeting? 
   2. When does FDA come for a BIMO audit i.e., do they come before the 100-day meeting or after the 100-day meeting?
3. Does FDA comes unannounced or they coordinate with the sponsor?

These insight will help us to plan our resources.