Initiation of Voluntary Recalls Draft Guidance for Industry and Food and Drug Administration Staff; Availability

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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry and FDA staff entitled "Initiation of Voluntary Recalls Under 21 CFR part 7, subpart C." The draft guidance, if finalized, would establish guidance for industry and FDA staff regarding timely initiation of voluntary recalls of FDA-regulated products. The draft guidance discusses what preparations firms in a distribution chain, including manufacturers and distributors, should consider making to establish recall initiation procedures; to ensure timely identification of, and response to, product problems that might lead to a recall; and to promptly issue recall communications and press releases or other public notices. It also discusses preparations that firms in a distribution chain should consider making to ensure timely responses to a recall communication. In addition, it discusses how FDA assists firms with carrying out their recall responsibilities to protect the public health from distributed products in violation of the Federal Food, Drug, and Cosmetic Act and other laws administered by FDA.