July 23, 2024

FDA Is Resuming Domestic Inspections With New Risk Assessment System

The FDA is resuming domestic inspections with a new risk assessment system during the coronavirus pandemic. Inspections were suspended in March 2020 as the pandemic was just starting. FDA inspectors have still “conducted mission critical inspections,” as they put it, even though regular inspections were suspended.

FDA Resuming Domestic Inspections With New Risk Assessment System

The agency continued to maintain reviews of consumer products, especially those related to the COVID-19 pandemic, including hand sanitizers made with methanol and diagnostic tests that were making potentially false claims.

The FDA has developed a rating system to let inspectors know when and where prioritized domestic inspections can begin. It’s called the COVID-19 Advisory Rating System and uses real time data to assess the number of COVID-19 cases in a local area based on state and national data. This information is also being transmitted to state partners who inspect FDA-regulated facilities under contract.

The Advisory Level is based on three metrics: Phase of the State, White House Guidelines, and statistics measured at the county level. The FDA will identify activities that can occur within a region. The three main categories of activity will be: mission critical inspections, all inspections with caveats to protect staff who are vulnerable, and resumption of all regulatory activities.

The agency hopes to begin inspections during the week of July 20, 2020.. But this date depends on data about the pandemic and outbreak trajectories in different states and localities and the guidelines put in place by those governments, stating, “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.”

The FDA is also pre-announcing prioritized domestic inspections to FDA-regulated businesses to assure the safety of the investigator and the firm’s employees, except for tobacco inspections, as those are undercover operations. Inspectors will be outfitted with personal protective equipment.


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