Description
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.
Scope & Applicability
Product Classes
4Food that is in a form that is edible without additional preparation to achieve food safety
Products containing dietary ingredients intended to supplement the diet; The final product category for which the NDI is intended.
subject to 21 CFR part 111; Foods not subject to preventive controls requirements; Specific product category with modified FSVP requirements.; Included in human food sales calculation; foods not covered under systems recognition arrangements
subject to 21 CFR parts 106 and 107
Stakeholders
1Records must be reviewed by a supervisor or responsible party.
Identified Hazards
Hazards
1Serious adverse health consequences or death to humans or animals; Serious Adverse Health Consequences or Death to Humans or Animals
Related CFR Sections (2)
- 21CFR117.3§ 117.3 Definitions.
The definitions and interpretations of terms in section 201 of the Federal Food, Drug, and Cosmetic Act apply to such terms when used in this part. The following definitions also apply:Read full regulation →
- 21CFR7.55§ 7.55 Termination of a recall.
(a) A recall will be terminated when the Food and Drug Administration determines that all reasonable efforts have been made to remove or correct the product in accordance with the recall strategy, and when it is reasonable to assume that the product subject to the recall has been removed and proper Read full regulation →
See Also (8)
- Small Entity Compliance Guide: Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (Status: Final)
- Guidance for Industry: Questions and Answers Regarding Food Facility Registration (Seventh Edition) (Status: Final)
- Draft Guidance for Industry: Guide to Minimize Food Safety Hazards of Fresh-cut Produce (Status: Draft)
- Guidance for Industry: Determining the Number of Employees for Purposes of the “Small Business” Definition in Parts 117 and 507 (Status: Final)
- Guidance for Industry: Seafood HACCP and the FDA Food Safety Modernization Act (Status: Final)
- Guidance for Industry: Juice HACCP and the FDA Food Safety Modernization Act (Status: Final)
- Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food (Status: Draft)
- Draft Guidance for Industry: Establishing Sanitation Programs for Low-Moisture Ready-to-Eat Human Foods and Taking Corrective Actions Following a Pathogen Contamination Event (Status: Draft)