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GUIDANCE DOCUMENT

Guidance for Industry and FDA Staff: Questions and Answers Regarding Mandatory Food Recalls November 2018

Final

This guidance is being distributed for comment purposes only.

Docket Number:
FDA-2015-D-0138
Issued by:
Guidance Issuing Office
Center for Food Safety and Applied Nutrition
Center for Veterinary Medicine
Office of Regulatory Affairs

The purpose of this document is to provide guidance to industry and FDA staff on the implementation of the mandatory food recall provisions of section 423 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) [21 U.S.C. § 350l] , which was added by section 206 of the FDA Food Safety Modernization Act of 2011 (FSMA). The guidance in this document is in the form of Questions and Answers and provides answers to common questions that might arise about these mandatory recall provisions and FDA’s current thinking regarding their implementation.

The FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.

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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-2015-D-0138.