FDA Recall Requirements

Comply with FDA's FSMA requirements for recalls under FDA's 21 CFR Subpart 7.
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Learn how to comply with FDA's Recall Requirements

Certificate of Completion

100% Self-Paced Online

Course Overview

An effective recall plan is even more so critical in recent years due to the growing complexity of supply chains, better detection of food safety issues, and more efficient mandated reporting by manufacturers and processors. It is also a regulatory requirement for food safety plans that have identified hazards requiring preventive controls. Recall is the ability to bring back potentially unsafe items or materials or put it on hold until it can be retrieved and/or dispositioned.
Traceability is the ability to trace an ingredient, packaging material, processing aid or finished product from harvest or receiving, through production and to the first delivery point away from the facility. Having a complete and up-to-date Recall plan that meets FDA requirements will be critical for carrying out a swift and effective recall. With this course, you will learn how to comply with FDA's FSMA requirements for recalls under FDA's 21 CFR Subpart 7. This course will be useful for individuals responsible for developing and managing traceability and recall programs, and for all members of the traceability and recall team.

Learn How To

  • Identify and understand product recall terms and definitions
  • Use the Reportable Food Registry to identify potential risks to products
  • Ensure your recall program complies with FDA guidance documents
  • Meet 21 CFR Part 7, Subpart C requirements for issuing public warnings and notification for recalls
  • Develop an effective traceability system including how to conduct mass balance
  • Report recall progress to regulatory officials, customers, consumers and media
  • Conduct mock exercises
  • Develop risk mitigation strategies

Who Needs this Course

  • If you need to comply with FDA regulations as a local producer or as an exporter to the U.S.
  • Recall Team Members
  • QA Directors and Managers
  • QA/Production Supervisors
  • Operations Managers
  • HACCP Coordinators
  • Food Safety Technicians
  • Food Safety/Food Science Graduates

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