FDA procedure for building a new facility

Hello folks from north America,

 

Can anyone please guide me the whole process of building a new food facility in U.S.?

My understand is building permit - FDA registration - FDA Approval to start production - USDA inspection for export.

 

Is that correct?

 

Any input would be much appreciated.

 

- Boston Cream

In the US, aside from Federal laws we have local laws. You would need to start with the health department for the county you want to build at first. They provide all the rules and regulations and will guide you through the Federal Laws. 

We've been involved in a number of ground up builds and it is a bit more complicated and based on the area, county, town, state, product types, sewer and water systems etc.

No one size fits all unfortunately.

An example of that is starting next month we are handling a project that involves 77 ground up locations within coastal areas and I need to hire at least one regulatory/risk/compliance person just to handle the web of all that stuff.