I was trying to look how to get the facility registration done, and I found the guidance for industry in the FDA website said "FDA will be permitted to inspect the facility at the times and in the manner permitted by the FD&C Act".
There are few questions I want to ask for help:
- Is FDA going to inspect the company during the registration?
- what if my company is oversea?
- what are they going to inspect?
- It said the registration is fee of charge, what about the travel fee for inspection?
- If I already have the login to create P/N, does that mean I have done the facility registration already?
I am kinda confused about the inspection. Hopefully someone could explain this. Thanks.