; or (ii) if the initial 5-year period under subparagraph (A) has not concluded, at the conclusion of such initial 5-year period. (C) The designation of the banned facility pursuant to an order under subsection (a), based on a second subsequent Class II recall of a drug or device manufactured or processed at the facility, shall be in effect permanently beginning— (i) if the first subsequent 5-year period under subparagraph (B) has concluded, one year after the issuance of the order; or (ii) if the first subsequent 5-year period under subparagraph (B) has not concluded, immediately. (c) Definition In this section: (1) The term banned facility means a banned foreign facility for which an order is in effect under subsection (a). (2) The terms Class I and Class II , in connection with a recall, mean classified as Class I or Class II, respectively, by the Food and Drug Administration pursuant to section 7.41 of title 21, Code of Federal Regulations (or any successor regulations). . (c) Applicability Section 810 of the Federal Food, Drug, and Cosmetic Act, as added by subsection (b), applies only with respect to recalls issued or reissued on or after the date of enactment of this Act. (d) Civil monetary penalties Subsection (f) of section 303 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 333 ) is amended by adding at the end the following new paragraph: (10) Any person who violates section 301(fff) shall be subject to a civil money penalty not to exceed— (A) if the violation involves a Class I recall, as described in section 810(a)(2)— (i) $25,000,000 if the violation is the first violation of section 301(fff) by such person; and (ii) $100,000,000 if the violation is a subsequent violation of section 301(fff) by such person; and (B) if the violation involves a Class II recall, as described in section 810(a)(2)— (i) $10,000,000 if the violation is the first violation of section 301(fff) by such person