FDA Resumes Inspections After COVID-19 Halt

August 5, 2020

The Food and Drug Administration (FDA) has resumed some domestic facility inspections following a temporary halt in in March as cases of COVID-19 increased in the United States.

For the “foreseeable future,” most businesses that will be inspected by the FDA will be informed beforehand in order to best protect the inspectors and the company’s employees. During their inspections, FDA staff and contractors will wear personal protective equipment, the agency said.

The FDA is restarting inspections using the White House Guidelines for Opening Up America Again as a roadmap as well as the Centers for Disease Control and Prevention (CDC) guidance for protecting workplace exposures to COVID-19 in non-healthcare settings.

While on-site inspections were largely shut down, the FDA said “mission critical inspections” continued and that the agency used other tools for surveillance of manufacturing facilities including remote assessments and import alerts. The FDA said it maintained the safety, in particular, of consumer products, including hand sanitizer and diagnostic tests.

The decision to resume inspections, according to the agency, is based on a close monitoring of reopening criteria established at the federal, state and county levels.  

The agency has established a rating system, called the COVID-19 Advisory Rating system, to help decide when and where it is safest to do domestic inspections. The rating system uses real-time state and national data to assess the number of COVID-19 cases in a local area. The FDA will be sharing that data with state partners who conduct any inspections on behalf of the FDA.

The rating system uses metrics including the phase of reopening a state is in (based on the White House guidelines) and statistics measured at the county level to gauge the current trend and intensity of COVID-19 infections. The FDA will take the metrics into account to determine the safety of three types of inspections: mission critical only, all inspections with caveats to help protect staff who have self-identified as being in a vulnerable population, and resuming all inspections.

But in addition to those metrics, according to the FDA, resuming inspections will depend on data about the virus’ trajectory in each state and locality and the rules and guidelines that are put in place by state and local governments and will have to see downward trends in new cases of COVID-19 and hospitalizations in a given area.” Resumption will also depend on whether there are available services in a community such as public transportation.