Guidance for Industry: Questions and Answers Regarding Establishment and Maintenance of Records by Persons Who Manufacture, Process, Pack, Transport, Distribute, Receive, Hold, or Import Food (Edition 5)

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The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "Questions and Answers Regarding Establishment and Maintenance of Records by Persons Who Manufacture, Process, Pack, Transport, Distribute, Receive, Hold, or Import Food (Edition 5)." This guidance provides updated information pertaining to the establishment and maintenance of records by persons who manufacture, process, pack, transport, distribute, receive, hold, or import food in the United States under the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the FDA Food Safety and Modernization Act (FSMA) of January 4, 2011.