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GUIDANCE DOCUMENT

Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C Draft Guidance for Industry and FDA Staff April 2019

Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2018-D-2074
Issued by:
Guidance Issuing Office
Office of Global Regulatory Operations and Policy, Office of Regulatory Affairs
Office of Medical Products and Tobacco, Center for Biologics Evaluation and Research
Office of Medical Products and Tobacco, Center for Drug Evaluation and Research
Office of Medical Products and Tobacco, Center for Devices and Radiological Health
Office of Foods and Veterinary Medicine, Center for Food Safety and Applied Nutrition
Office of Medical Products and Tobacco, Center for Tobacco Products
Office of Foods and Veterinary Medicine, Center for Veterinary Medicine

The purpose of this draft guidance is to clarify FDA’s recommendations for industry and Agency staff regarding timely initiation of voluntary recalls under 21 CFR part 7, Subpart C – Recalls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  The draft guidance discusses what preparations firms in a distribution chain, including manufacturers and distributors, should consider making to establish recall initiation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 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. 


Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

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

Questions?

Contact Point
ORA Office of Strategic Planning and Operational Policy (OSPOP)
Contact for guidance document questions