FDA Releases New Chapter of PC Human Food Draft Guidance on Developing A Recall Plan

Nov 04, 2019 | Michelle Shapiro

The U.S. Food and Drug Administration (FDA) is announcing the availability of draft guidance that explains how food facilities subject to the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food (CGMP & PC Human Food) rule can establish and implement a written recall plan.

This is Chapter 14 of the draft guidance, entitled “Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food ‚” designed to help food facilities comply with the PC Human Food rule, mandated by the FDA Food Safety Modernization Act. The rule specifies that food facilities must establish a written recall plan for food that requires a preventive control that includes plans for:

  • Notifying consignees of the food being recalled, including how to return or dispose of the affected food
  • Notifying the public about any hazards presented by the food
  • Conducting effectiveness checks to verify that the recall is carried out
  • Appropriately disposing of recalled food in a way that does not present a safety concern.

The draft guidance provides recommendations that industry may choose to use when developing their recall plans. It also includes resources that the FDA has previously made available to assist with recalls which may help with the preparation of these plans.


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About Michelle Shapiro

Michelle Shapiro was formerly a communication specialist for the Environmental Health & Disability team at NACCHO.

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