- On May 11, 2020, the U.S. Food and Drug Administration (FDA) provided an update in regard to the agency’s surveillance inspections during the COVID-19 pandemic. In its update, FDA stated that it will continue to utilize and implement additional alternative inspection tools and approaches, while postponing domestic and foreign routine surveillance inspections. FDA also stated that it is working with the Centers for Disease Control and Prevention (CDC) on a phased plan for resuming on-site surveillance inspections. This phased plan would govern how to return to on-site facility surveillance inspections in accordance with the gating criteria outlined in the White House Guidelines for Opening Up America Again to ensure inspections are carried out safely.
- By way of background, in March 2020, FDA provided an update noting that it had implemented alternative approaches to on-site surveillance inspections. In that update, FDA stated that it was temporarily postponing all domestic routine surveillance facility inspections, which are facility inspections the FDA traditionally conducts every few years based on a risk analysis. Instead of conducting on-site inspections, the agency said it would resort to alternative means of oversight, such as evaluating records from facilities.
- In its May 11, 2020 update, FDA commissioner Stephen Hahn noted that alternative approaches to on-site surveillance inspections will continue as local, national and international conditions warrant, with the exception of certain mission critical inspections. We will continue to monitor any developments.