FSMA update: FDA issues compliance program guidance manual for preventive controls inspections

This post summarizes the U.S. Food and Drug Administration (FDA) Compliance Program Guidance Manual (CPGM) for food facilities subject to preventive controls and sanitary human food operation requirements.

As an overview, FDA's "Compliance Programs" provide instructions to FDA personnel for conducting activities to evaluate industry compliance with the Federal Food, Drug, and Cosmetic Act (FFDCA) and other laws administered by FDA. This compliance program in particular covers inspections of businesses subject to the Preventive Controls for Human Foods (PCHF) rule that was issued under the FDA Food Safety Modernization Act (FSMA).

The CPGM outlines which facilities should be inspected based on risk, the type of inspection that should occur based on business activities, applicable enforcement activities based on the results of the inspection, and any follow-up required. Issued last fall, the CPGM is significant because it guided PCHF inspections until they were postponed due to the COVID-19 pandemic and will guide inspections going forward once they are resumed. Issuance of the CPGM marks a new phase in PCHF inspections and enforcement.

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