; (ii) complaint investigation, adverse event reporting, and corrections and removals; and (iii) process validation, as applicable; (C) based on a fair evaluation of all material facts, the applicant’s proposed labeling and advertising are not false or misleading in any particular; (D) the application does not contain a false statement of material fact; (E) there is a showing that the representative in vitro clinical test or tests— (i) meet the applicable standard; and (ii) reasonably represent the range of procedures required to be submitted in the application; (F) the applicant has agreed to permit, upon request, authorized employees of the Food and Drug Administration or persons accredited, or recognized under this Act, an opportunity to inspect at a reasonable time and in a reasonable manner the facilities and all pertinent equipment, finished and unfinished materials, containers, and labeling therein, including all things (including records, files, papers, and controls) bearing on whether an in vitro clinical test is adulterated, misbranded, or otherwise in violation of this Act, and permits such authorized employees or persons accredited under this Act to view and to copy and verify all records pertinent to the application and the in vitro clinical test