FDA to Resume Prioritized Food Facility and Other Domestic Inspections Based on New Risk Assessment System

On July 10, 2020, the U.S. Food and Drug Administration (FDA) announced that it will be restarting on-site prioritized domestic inspections, including food facilities, during the week of July 20 after pausing such inspections since March due to the COVID-19 pandemic. FDA will pre-announce prioritized domestic inspections to ensure the safety of the investigator and business employees as well as the availability of on-site staff to assist the investigator with inspection activities.

FDA will use its new COVID-19 Advisory Rating system (COVID-19 Advisory Level) to determine when and where to safely conduct prioritized domestic inspections. The Advisory Level is based on three metrics:

• Phase of the State as determined by The White House Guideline for Opening Up America Again;
• The current trend of infection; and
• The current intensity of infection as measured at the county level.

Based on these three metrics, FDA will identify which level of regulatory activity may occur in a given geographic region:

• Mission critical inspections only;
• All inspections with caveats to help protect staff who have self-identified as being in a vulnerable population; or
• Resumption of all regulatory activities.

The Advisory Level will be available to FDA’s state partners who are under contract to carry out inspections on the agency’s behalf.

Investigators will wear personal protective equipment and adhere to guidance issued by the Centers for Disease Control and Prevention, as well as state and local agencies. FDA’s resumption of on-site prioritized domestic inspections will depend on data about the trajectory of the virus in a given geographic region, rules and guidelines put in place by state and local governments, and the availability of other services such as public transportation.

As the number of cases around the world grows, Faegre Drinker’s Coronavirus Resource Center is available to help you understand and assess the legal, regulatory and commercial implications of COVID-19.