FDA requirement on manufacturing facility registration

Hi Team, 

Can anyone please advise that if it is necessary to have a GFSI approved quality system to go for an FDA manufacturing facility registration? 

Our facility is basic HACCP certified and I can understand that FDA has more thorough requirements on VACCP, TACCP and supplier approval. 

Any thoughts on this is highly appreciated. 

Thank you very much. 

Thanks for the quick respond Glen. Much appreciated. 

Hi Glenn, just another quick question.

We are manufacturing infant formula in Aus and to export to USA we need to get both the product approval and facility registration. I've recently heard that under the emergency presidential resolution the facility registration part is not applicable as far as we can provide the HACCP, supplier verifications, environmental monitoring, zoning, third party audit details etc. 

Do you know much about this?

Thanks 

See link below for current guidance. 

https://www.fda.gov/...158476/download