; or (ii) deny approval of the application by issuing a written notice to the accredited person and the applicant detailing the scientific basis for a determination by the Secretary that the criteria for issuance of a technology certification order under section 587D(d)(3) have not been met. (c) Requirements for inspections (1) In general When conducting inspection, persons accredited under subsection (a)(1)(C) shall record in writing their specific observations and shall present their observations to the designated representative of the inspected establishment. (2) Inspection report requirements Each person accredited under subsection (a)(1)(C) shall prepare and submit to the Secretary an inspection report in a form and manner designated by the Secretary for conducting inspections. Any statement or representation made by an employee or agent of an establishment to a person accredited to conduct inspections under subsection (a)(1)(C) shall be subject to section 1001 of title 18, United States Code. (3) 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 587J or recognize inspections conducted by auditing organizations as described under section 704(g)(15). (4) 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— (A) for routine surveillance activities of facilities associated with an approved application under section 587B or issuance of a technology certification order under section 587D