Hogan Lovells Publications | A Seat at the Table | 11 October 2019

FSMA Update: FDA Issues Draft Guidance on Recall Plans Under the Preventive Controls for Human Food Rule

The U.S. Food and Drug Administration (“FDA”) recently released Chapter 14 of its Draft Guidance for Industry, “Hazard Analysis and Risk-Based Preventive Controls for Human Food” (“Draft Guidance”). 

Entitled “Recall Plans,” the chapter explains how food facilities subject to the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food Rule (“PCHF Rule”) can establish and implement a written recall plan. This memorandum provides a brief overview of the Draft Guidance. Comments on the Draft Guidance should be submitted by February 4, 2020.

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