; and (ii) shall issue a public notice on the internet website of the Food and Drug Administration calling for applications for such accreditation. (C) Effect of accreditation (i) In general Persons accredited under subparagraph (A) to conduct inspections, when conducting such inspections, shall record in writing their specific observations and shall present their observations to the designated representative of the inspected establishment. (ii) Inspection report requirements Each person accredited under this paragraph shall prepare and submit to the Secretary an inspection report in a form and manner designated by the Secretary for conducting inspections, taking into consideration the goals of international harmonization of quality systems standards. Any official classification of the inspection shall be determined by the Secretary. Any statement or representation made by an employee or agent of an establishment to a person accredited to conduct inspections shall be subject to section 1001 of title 18, United States Code. (D) Savings clause Nothing in this section affects the authority of the Secretary to inspect any in vitro clinical test developer or other person registered under section 587I. (E) Inspection limitations The Secretary shall ensure that inspections carried out under this section are not duplicative of inspections carried out under section 353 of the Public Health Service Act. Inspections under this section shall be limited to the data and information necessary— (i) for routine surveillance activities associated with applications under sections 587B and 587D