FDA To Resume Domestic Inspections with New Risk-Assessment System
The US Food and Drug Administration (FDA) is working toward resuming onsite domestic inspections in the US beginning the week of July 20, 2020, with a new risk-assessment rating system to determine when and where it is safest to conduct prioritized domestic inspections based onCOVID-19-related information in states and localities. The FDA had paused onsite surveillance inspections in the US beginning in March (March 2020) due to the COVID-19 outbreak.
Prioritized domestic inspections will be pre-announced to FDA-regulated businesses. “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,” said FDA Commissioner Stephen Hahn, in a July 10, 2020 statement. “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 rating system, the COVID-19 Advisory Rating system (COVID-19 Advisory Level), will use real-time data to qualitatively assess the number of COVID-19 cases in a local area based on state and national data and will make that data available to 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: the phase of the state, as defined by 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 says it 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.
The FDA said it will ensure 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 Centers for Disease Control and Prevention (CDC) guidance.
Source: US Food and Drug Administration