FSMA Inspections

FSMA Inspections

FSMA inspections are well underway. The Food Safety Modernization Act (FSMA) is slowly beginning to roll out. The implementation is a learning curve both for industry and the FDA. Still there have been dozens of inspections. FDA Atty completed a Freedom of Information Act (FOIA) request with the FDA’s Center for Food Safety and Nutrition and the Office of Regulatory Affairs. CFSAN would handle any FSMA inspections of a foreign facility while ORA would conduct any domestic FSMA inspections.

Inspections are focused on two parts. First, on modernized GMPs. GMP inspections are routine and at the heart of any inspection. Second, the inspections audit for compliance with FSMA’s core rules. This is in addition to a heavy amount of swabbing.

The HARPC rule went into effect in September and was the only FSMA rule produced under the FOIA request. The FSVP rule became effective at the end of May.

To-date only one entity as been cited for not following a substantive component of HARPC. That facility was cited for “Failure to identify a known or reasonably foreseeable hazard during the hazard analysis,” during an inspection on November 29 – December 2. The action that led to the citation was a failure identify a chemical hazard for allergen cross-contact and implement a preventative control to control cross contact. It is notable the first FSMA citation is focused on allergens. Not a surprising result given the amount of focus and attention allergens have received under FSMA. It is also interesting that the facility relied on a HACCP plan rather than a food safety plan. As mentioned in previous posts and presentations there is a risk using a voluntary HACCP plan rather than a required food safety plan. In particular, if no gap analysis is conducted.

Below are some additional details from the FOIA request.


Districts Responding

San Francisco








New Orleans






New York


All other The FSMA inspections to date have cited only one (1)

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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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