FDA Extends Pause on Food Safety Inspections Due To Omicron Variant

Amid the continued spread of the COVID-19 Omicron variant across the US, federal food safety regulators are extending a pause placed on food safety inspections, which was initially issued late last month.

The U.S. Food and Drug Administration (FDA) paused food, drug, tobacco and medical product safety inspections on December 29, which was intended to end January 19. However, this week the agency issued further pause for domestic inspections through at least February 4.

The extension was issued to ensure the safety of agency employees and other firms employed by the FDA to regulate inspections. With the rapid spread of Omicron variant infections across the U.S., and record-braking infections and hospitalizations, FDA officials say they wanted to prevent the further spread of COVID-19. However, these concerns have to be weighed against risks to the U.S. food and drug supply that may result from an extended period without regulatory inspections.

The agency said it plans to restart inspection activities as soon as safely possible. The inspections play a key role in early detection of food poisoning outbreaks and determining whether food recalls are warranted.

The extended pause applies to domestic surveillance and safety inspections, but not for foreign inspections. And the agency indicates it will “continue mission-critical inspections both domestic and foreign.”

The FDA will continue to proceed with foreign surveillance inspections that have received country clearance and are within the CDC’s level 1 or 2 COVID-19 travel recommendation. If the inspections are not within that scope, the inspections will be rescheduled. The goal is to return to the regular schedule of foreign inspections by April 2022.

Furthermore, the agency will continue with remote foreign supplier verification program activities for human and animal foods and will use remote assessments and import operations surveillance to help with oversight in the meantime.

The FDA stopped inspection work temporarily in 2020, at the start of the coronavirus pandemic, but returned to standard operations in July 2021. By November, the agency completed more than 1,000 domestic inspections out of 3,200 outstanding inspections.

Until the most recent pause, the FDA anticipated it would complete its backlog of domestic inspections in 2022, but the problems the agency faces are extensive both domestically and for foreign inspections of drug and medical products, including overseas staffing shortages and language barriers.