US FDA working to restart on-site inspections during week of July 20

The US Food and Drug Administration recently announced that it will resume prioritised domestic inspections of FDA-regulated facilities and other associated activities since it first announced postponement in March due to the COVID-19 pandemic. The regulatory body said that it will be running its operations  following the guidance issued by the US Centers for Disease Control and Prevention (CDC) and the  The White House Guidelines for Opening Up America Again for protecting workplace exposures to COVID-19 in non-healthcare settings.

Discussing how the agency has worked around the operational impediments caused by the COVID-19 crisis, the US FDA stated, “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.”

To arm its investigators with reliable and accurate information, the FDA has developed a rating system to assist them 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. The three main categories of regulatory activity which will be carried out by the US FDA at 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.

The US FDA stated that it is working toward the goal of restarting on-site inspections around July 20. However, resuming prioritised 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. Restarting of operations in a specific area will be subject to a downward trend in new cases of COVID-19 and hospitalizations in a given area, along with the state of other services that have been curtailed by the pandemic, such as public transportation.

On the safety measure which will be carried out to ensure optimum safety for the investigators, the FDA reported, “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.”