The U.S. Food and Drug Administration (FDA) is announcing the availability of draft guidance that explains how food facilities subject to the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food (CGMP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This is Chapter 14 of the draft guidance, entitled “Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food ,” designed to help food facilities comply with the PC Human Food rule,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:
The draft guidance provides recommendations that industry may choose to use when developing their recall plans.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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