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FSMA update: FDA announces pilot program to evaluate third-party food safety standards

The Food and Drug Administration (FDA) recently announced a pilot program to evaluate whether third-party food safety standards align with the food safety requirements in FDA’s Preventive Controls for Human Food (PCHF) and...more

COVID-19 Update: FDA Provides Update on Inspection Plans

The U.S. Food and Drug Administration (FDA) recently provided an update regarding its plans for conducting routine surveillance inspections of domestic and foreign facilities during the COVID-19 pandemic. FDA announced in...more

FSMA Update: FDA Publishes List of Required Foreign Supplier Verification Program Records

The U.S. Food and Drug Administration (FDA) recently published a list of the records that importers are required to develop and maintain under the Foreign Supplier Verification Program (FSVP) regulation....more

Settlement Reached in Lawsuit to Compel FDA to Implement FSMA Traceability Provisions

The U.S. Food and Drug Administration (FDA) reached a settlement with the two consumer groups that sued FDA in October 2018 to compel the agency to implement the traceability provisions in the FDA Food Safety Modernization...more

FDA Commissioner Gottlieb and Deputy Commissioner Yiannas Issue Statement on New Steps to Strengthen FDA’s Food Safety Program for...

FDA Commissioner Scott Gottlieb, M.D., and Deputy Commissioner Frank Yiannas recently issued a statement addressing new steps included in the President’s 2020 Budget proposal to advance FDA’s food safety program and expand...more

Produce Safety Rule Inspections Will Begin Soon

U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb recently issued a statement affirming that Produce Safety Rule inspections will begin this spring. Last year FDA chose to delay routine inspections to allow...more

FDA Issues Final Guidance on Mandatory Recall Authority under FSMA

The Food and Drug Administration (FDA) recently issued final Guidance regarding its mandatory recall authority, which was granted to FDA by the FDA Food Safety Modernization Act (FSMA). Together with the release of this...more

FDA Announces Pilot Program for Two-Tier Preventive Controls for Human Food Inspections under FSMA

The U.S. Food and Drug Administration (FDA) recently announced that it will engage in a pilot program to evaluate the benefits of two-tier inspections for some aspects of the Preventive Controls for Human Food (PCHF) rule...more

FSMA Implementation Update (March 2018)

There have been several recent developments regarding implementation of the FDA Food Safety Modernization Act (FSMA). The below post summarizes the following topics: - Guidance on application of the Foreign Supplier...more

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