Is a foreign facility required to provide assurance that FDA will be permitted to inspect the facility?

Yes. Section 415(a)(2) of the FD&C Act, as amended by section 102(b) of FSMA, requires that
food facility registrations contain an assurance that FDA will be permitted to inspect the facility
at the times and in the manner permitted by the FD&C Act. The assurance is required for food
facilities in order to complete their food facility registration.