Regulatory Open Forum

We manufacture drugs both by NDA/ANDA and OTC monograph. We are currently moving the OTC monograph manufacture to another building but still within a contiguous campus. Do we need to have the FDA inspect the facility before we can release to the market? If so, how do we trigger that inspection?

Any of the approved NDA or ANDA product impacted by this move? if so, you need to file sNDA or Annual report first whichever appropriate given the changes, then the FDA would determine if inspection is needed!