The U.S. Food and Drug Administration paused its on-site inspections back in March, but says it plans to resume those the week of July 20. That plan starts with using a new COVID-19 Advisory Rating system (explained below if you care) to determine where it is safest to resume which levels of inspections.
The FDA has also determined that, for the foreseeable future, prioritized domestic inspections will be pre-announced to FDA-regulated businesses to help assure the safety of all involved.
To this point the FDA has kept things moving with remote assessments and import alerts as well as other compliance requirements. As the COVID-19 pandemic continued, they adjusted their 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, they’ve been 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.
But my state has more COVID cases than ever – are they still coming?
Again, the goal is restarting on-site inspections during the week of July 20, but it 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.”
Here’s more info than you’ll ever need on how they’ll be figuring that out:
The FDA’s new 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. They are also making the Advisory Level data available to its 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.