§860.240. Procedures for review of a De Novo request. — Inbound Citations

(1) The requester fails to provide a complete response to a request for additional information pursuant to § 860.240(b)(1) within 180 days after the date FDA issues such request;

(ii) Deficiencies related to the investigation and identified in any request for additional information under § 860.240(b)(1) have not been adequately addressed; or

(3) The requester does not permit an authorized FDA employee an opportunity to inspect the facilities, pursuant to § 860.240(c), at a reasonable time and in a reasonable manner, and to have access to copy and verify all records pertinent to the De Novo request; or

(7) An inspection of a relevant facility under § 860.240(c) results in a determination that general or general and special controls would not provide reasonable assurance of safety and effectiveness;