FDA Exceeds Pandemic-Stunted Inspection Goals

FDA Headquarters

It’s getting to be annual review time for many employees, and the U.S. Food and Drug Administration (FDA) has issued its own pretty favorable report on how it handled inspection activities during the COVID-19 pandemic.

The agency exceeded its own inspection projections in fiscal year (FY) 2021, according to its November 2021 “An Update to the Resiliency Roadmap for FDA Inspectional Oversight” report.

FDA estimated that, as of March 31, 2021, more than 15,000 domestic surveillance inspections that had been planned to be completed during FY20 and FY21 had been postponed due to the COVID-19 pandemic.

FDA projected that approximately 14% of the 15,514 domestic surveillance inspections still to be conducted in FY21 could be completed. This included 1,272 (10%) of the 12,285 remaining human and animal food domestic surveillance inspections and 851 (26%) of the 3,229 outstanding human and animal medical products inspections.

As of September 30, 2021, FDA has exceeded the projections for FY21, completing more than twice as many domestic surveillance oversight activities as projected.

“FDA’s development of new oversight approaches and expanded use of a variety of surveillance tools significantly contributed to the agency’s ability to exceed these goals,” the agency said in the new report.

Edited by Michael Causey