21 C.F.R. § 121.401 Compliance.
(a) The operation of a facility that manufactures, processes, packs, or holds food for sale in the United States if the owner, operator, or agent in charge of such facility is required to comply with, and is not in compliance with, section 418 of the Federal Food, Drug, and Cosmetic Act or subparts C or D of this part is a prohibited act under section 301(uu) of the Federal Food, Drug, and Cosmetic Act.
(b) The failure to comply with section 420 of the Federal Food, Drug, and Cosmetic Act or subparts C or D of this part is a prohibited act under section 301(ww) of the Federal Food, Drug, and Cosmetic Act.