FDA FSVP and FSMA Enforcement Update

Marc recently attended the Food and Drug Law Annual conference as a speaker alongside FDA’s interim director of FSMA Operations, Jennifer Thomas. Marc and Jennifer were also joined by Steve Armstrong of EAS consulting. Together they present on key updates from the FDA’s enforcement of FSMA.

The FDA’s FSVP and enforcement update slides can be found at the link: FDA FSMA Slides.

The FDA provided new insight into the enforcement of FSMA, including FSVP. As expected the FDA described an educational approach where parties new to regulation like import brokers are guided through the FSVP rule. The most significant FSVP violations at the moment are a total absence of any foreign supplier verification plan and where a plan does exist documentation on approving or rejecting foreign suppliers. It was clear from the FDA’s presentation that FSVP inspections are happening and many importers are far from ready.

In addition to an FDA FSVP update, the FDA noted it plans to begin inspections under the PC rule for animals, some parts of Produce Safety rule, and the Intentional Adulteration rule. The FDA also noted it is currently a small add-on to the inspection of a shipper. It’s not clear how long this approach will be in place before carriers are also inspected.

Summary of FSMA Enforcement Update:

  • FSVP inspections are ongoing across industry;
  • FDA expects importers to have started FSVP compliance but is not yet citing for deficiencies;
  • Modernized GMPs and Part 117 (PC for Human Food) continues;
  • Sanitary Transport inspections are being rolled out first with shippers;
  • Inspections of sprout production under Produce Safety rule has begun; and
  • PC for animals, intentional adulteration and parts of Produce Safety will soon be inspected.
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Marc Sanchez

Marc Sanchez

Marc is dedicated to helping his clients navigate the complex world of FDA and USDA legislation. He represents FDA-regulated companies in the food, dietary supplement, beverage, cosmetic, medical device, and drug industries.

Marc is the author of two textbooks and a lecturer at Northeastern University. He is a member of the Washington State Bar Association and the D.C. Bar Association.

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