FDA to Resume FSMA Inspections

Posted by Carol Miller|July 15, 2020

FDA paused non-critical, on-site Food Safety Modernization Act (FSMA) inspections in March at the start of the COVID-19 lockdowns. It announced it will now resume inspections in areas where COVID-19 infection rates show an downward trend.

“To arm our investigators with the most reliable and accurate information, the FDA has developed a rating system to assist us in determining when and where it is safest to conduct prioritized domestic inspections,” FDA’s Commissioner of Food and Drugs Stephen Hahn said in a statement on July 10.

Inspections Resume Next Week

Although Hahn hopes inspections will resume during the week of July 20, COVID-19 trends will continue to have an impact on timing. FDA will use a rating system to determine when it’s safe for its inspectors to begin on-site visits. It’s a rating system based on three metrics:

Phase of the State (determined by White House guidelines)
County level infection trends
County level infection intensity

There are also three main categories of regulatory activity FDA is prioritizing, Hahn says:

“Mission-critical inspections only
“All inspections with caveats to help protect staff who have self-identified as being in a vulnerable population
“Resumption of all regulatory activities”