FDA Prepares for Resumption of Domestic Inspections with New Risk Assessment System

The U.S. Food and Drug Administration has been thoughtfully and deliberately determining the safest and most appropriate time to resume prioritized domestic inspections of FDA-regulated facilities and other associated activities since we first announced postponement in March. The White House Guidelines for Opening Up America Again are providing us a roadmap for optimizing operations and new work arrangements, as well as the Centers for Disease Control and Prevention (CDC) guidance for protecting workplace exposures to COVID-19 in non-healthcare settings.

Despite pausing on-site surveillance inspections in the U.S. in March, our investigators have conducted mission critical inspections and other activities to ensure FDA-regulated industries are meeting applicable FDA requirements. We have had great success by using a number of tools as part of the agency’s risk-based approach to ensuring quality, including remote assessments and import alerts as well as other compliance requirements. As the COVID-19 pandemic continued, we adjusted our processes and guidance as necessary to maintain the appropriate level of review to ensure the safety of consumer products, including hand sanitizer, diagnostic tests and more.

At the same time, we have been closely monitoring reopening criteria established at the federal, state or county levels and planning to identify when and where to resume domestic inspections, prioritizing the inspections based on risk and other factors.

To arm our investigators with the most reliable and accurate information, the FDA has developed a rating system to assist us in determining when and where it is safest to conduct prioritized domestic inspections. The COVID-19 Advisory Rating system (COVID-19 Advisory Level) uses real-time data to qualitatively assess the number of COVID-19 cases in a local area based on state and national data. We are also making the Advisory Level data available to our state partners who carry out inspections of FDA-regulated entities on the agency’s behalf under contract.

The Advisory Level is based upon the outcome of three metrics: Phase of the State (as defined by the White House guidelines) and statistics measured at the county level to gauge the current trend and intensity of infection. When each of these is taken into consideration, the FDA will identify regulatory activities that can occur within the given geographic region. The three main categories of regulatory activity at the county level will be: 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.

At this time, we are working toward the goal of restarting on-site inspections during the week of July 20. However, resuming prioritized domestic inspections will depend on the data about the virus’ trajectory in a given state and locality and the rules and guidelines that are put in place by state and local governments. In order to move to the next phase, we must see downward trends in new cases of COVID-19 and hospitalizations in a given area. Our ability to resume is also affected by other services that have been curtailed by the pandemic, such as public transportation. The availability of these services will be an important factor in how we determine resuming domestic inspections.

The FDA has also determined that, for the foreseeable future, prioritized domestic inspections will be pre-announced to FDA-regulated businesses. This will help assure the safety of the investigator and the firm’s employees, providing the safest possible environment to accomplish our regulatory activities, while also ensuring the appropriate staff are on-site to assist FDA staff with inspection activities. Due to the nature of retail tobacco inspections, these inspections will not be pre-announced when they resume, as they are undercover operations where the retailer is unaware an inspection is taking place.

The health, safety and well-being of our investigators, as well as the public, are of the utmost importance to us. We will ensure our investigators are outfitted with personal protective equipment and are equipped with other necessary equipment to carry out their work while adhering to state and local guidance as well as applicable CDC guidance. We will continue to work to ensure our prioritized domestic inspections resume appropriately and as safely as possible.