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FDA Announces Plans for Resuming On-Site Domestic Inspections of Food Facilities

Risk-based inspection priorities mandated by the FDA Food Safety Modernization Act (FSMA) of 2011 require FDA to conduct routine inspections of high-risk domestic facilities at least once every three years.  In March 2020, FDA announced that it was temporarily postponing all routine on-site inspections of domestic food facilities and would instead resort to alternative means of oversight, such as evaluating records from facilities for as long as conditions warrant with respect to the corona virus pandemic.

FDA’s July 10, 2020 Coronavirus (COVID-19) Update: Daily Roundup announced the release of a statement on plans for resuming on-site domestic inspections beginning July 20, 2020 at certain food facilities.  Prioritized domestic inspections under this plan will be pre-announced to FDA-regulated businesses.  Facilities where on-site inspections can resume will be determined under a newly developed COVID-19 Advisory Rating system (COVID-19 Advisory Level).  The Advisory Level is based on the Phase of the State (as defined by the White House guidelines on Opening Up America Again) and statistics measured at the county level to gauge the current trend and intensity of infection.  The resumption of inspections is contingent on FDA observing downward trends in new cases of COVID-19 and hospitalizations in the geographic region where a facility is located.  FDA will identify regulatory activities that can occur at the county level as follows:

  • mission critical inspections only,
  • all inspections with caveats to help protect staff who have self-identified as being in a vulnerable population, and
  • resumption of all regulatory activities.
© 2020 Keller and Heckman LLPNational Law Review, Volume X, Number 195


About this Author

Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...