Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C Guidance for Industry and FDA Staff March 2022

GUIDANCE DOCUMENT

• Docket Number: FDA-2018-D-2074
• Issued by: Center for Veterinary Medicine; Office of Inspections and Investigations; Human Foods Program; Center for Biologics Evaluation and Research; Center for Devices and Radiological Health; Center for Drug Evaluation and Research; Center for Tobacco Products

The purpose of this guidance is to clarify FDA’s recommendations for industry and Agency staff regarding timely initiation of voluntary recalls under 21 CFR part 7, subpart C – Recalls (Including Product Corrections) – Guidance on Policy, Procedures, and Industry Responsibilities.  The 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 firms in the distribution chain should consider making to ensure timely responses to a recall communication.  Additionally, 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 (FD&C Act) and other laws administered by FDA.

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All written comments should be identified with this document's docket number: FDA-2018-D-2074.

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