FSVP Enforcement
TO BE STRICTER
IN MARCH 2019
By Leonardo Natale, Fact Consulting, Inc.
March 19, 2019 will be the last key date in the FDA’s rolling enforcement calendar for its Foreign Supplier Verification (FSVP) regulations. In 2017 the FDA conducted only a few hundred FSVP inspections because the agency struggled to find importers that were subject to the regulation. In 2018 the FDA planned to inspect 2,275 FSVP Importers; the agency has so far inspected 242 FSVP Importers.
Glenn Bass, Director of FDA Office of Human and Animal Food Operations West, spoke at the Food Safety Preventive Control Alliance (FSPCA) Annual Meeting in Chicago in July. He described the FDA’s approach as “soft” until March 2019, to help the FSVP Importers better understand their new tasks and obligations, as the agency spreads awareness of the new FSMA rules. The FDA conceded that there is confusion domestically about the difference between the Importer of Record and the FSVP Importer. Mr. Bass also acknowledged that there remains some confusion abroad regarding the mandatory nature of FSMA. It is no longer a voluntary standard but is now federal law with FDA jurisdiction over registered food facilities.
Through an exchange on the FSPCA’s website, the FDA answered this question: “How will the existing GFSI (Global Food Safety Initiative) certifications of companies be affected by preventive controls?” The FDA responded by saying, “Firms that have received GFSI recognized certifications will need to comply with FDA’s Preventive Controls regulation regardless of their certification. Third party audits and certifications will not be accepted in lieu of an FDA inspection . . .”
Fact Consulting, Inc., Food Safety Agency of Consultants and Traders, offers twenty years of experience in import and export from Europe and Asia, with the knowledge and experience to work as an FSVP agent. Visit our website at FactConsultingAndTraders.com In the United States +1 609-369-1931